CAT Final

Clinical Summary: As in the past, please briefly outline the scenario and state your clinical question as concisely and specifically as possible.
23 year old female G3P0020 presents at 21w4d complaining of bloody vaginal discharge beginning 4 hours prior to arrival. Ultrasound & physical exam completed in triage a found anhydramnios and preterm pre-mature rupture of membranes. Fetus at pre-viable gestational age and fatal outcomes of pregnancy discussed with patient. Discussed medical management with induction of labor vs. surgical management with dilatation and evacuation. Patient spiked fever overnight and started on antibiotics and diagnosed with septic (inevitable) abortion.

Search Question: Clearly state the question (including outcomes or criteria to be tracked)
In a second-trimester pregnancy, what abortion intervention yields better maternal outcomes, medical or surgical management?

PICO Search Elements: Identify the PICO elements – this should be a revision of whichever PICO you have already begun in a previous week.

P	I	C	O
Pregnant female	Medical management of abortion	Surgical management of abortion	Maternal outcomes
Second-trimester pregnant female	Misoprostol	Dilatation and evacuation	Decreased risk of complications
Midtrimester pregnancy	Induction of labor	Suction & curettage	Lower morbidity and mortality rate

Search Strategy: Outline the terms used, databases or other tools used, how many articles returned, and how you selected the final articles to base your CAT on. This will likewise be a revision and refinement of what you have already done. A minimum of 3 search databases should be used.

PUBMED:

• Misoprostol versus dilation and evacuation → 26
  • Misoprostol versus dilation and evacuation → 16 (last 10 years)
• Induction vs dilation and evacuation → 10
  • Induction vs dilation and evacuation → 2 (Review)
• Comparison of medical induction and dilation and evacuation for second-trimester abortion → 7

GOOGLE SCHOLAR:

• Induction vs dilation and evacuation → 22,400
  • Induction vs dilation and evacuation second trimester → 17,800
  • Induction vs dilation and evacuation second trimester → 8,550 (Last 10 years)

SCIENCE DIRECT:

• Misoprostol versus dilation and evacuation → 396
  • Misoprostol versus dilation and evacuation → 51 (Review Articles)
  • Misoprostol versus dilation and evacuation → 36 (Review Articles + Last 10 Years)

ACOG*: (understand not a database, but still believe it’s important to include the current practice guidelines)

• Second term abortion clinical guidelines → 1

Articles Chosen (5-8) for Inclusion (please copy and paste the abstract with link):
Please pay attention to whether the articles actually address your question and whether they are the highest level of evidence available. (Be aware that the instructor may also do a search and should not be able to find better articles that you overlooked).

1. ACOG Clinical Guidelines / Practice Bulletin*

In the United States, more than one half of pregnancies are unintended, with 3 in 10 women having an abortion by age 45 years (1). In 2008, 1.2 million abortions occurred in the United States, of which 6.2% took place between 13 weeks of gestation and 15 weeks of gestation, and 4.0% took place at 16 weeks of gestation or later (2, 3). Only 1.3% of abortions are performed at 21 weeks of gestation or later (4). The proportion of abortions performed in the second trimester, usually defined as between 13 weeks of gestation and 26 weeks of gestation (as calculated from the last menstrual period), has remained stable during the past two decades (4). The purpose of this document is to provide evidence-based guidelines for the medical and surgical methods of second-trimester termination as well as for the management of associated complications.

2. Retrospective Cohort

Bryant AG, Grimes DA, Garrett JM, Stuart GS. Second-trimester abortion for fetal anomalies or fetal death: labor induction compared with dilation and evacuation. Obstet Gynecol 2011;117:788–92. DOI:10.1097/AOG.0b013e31820c3d26

OBJECTIVE: To compare the safety and effectiveness of dilation and evacuation (D&E) and labor-induction abortion performed for fetal anomalies or fetal death in the second trimester
METHODS: We performed a retrospective cohort study of second-trimester abortions performed for fetal indications. We compared the frequency of complications and effectiveness of abortions performed at 13–24 weeks for these indications. We calculated proportions of patients with complications for these two methods and controlled for confounding using a log binomial model.
RESULTS: Labor-induction abortions had higher complication rates and lower effectiveness than did D&E. Thirty-two of 136 women undergoing labor induction (24%) experienced one or more complications, in contrast to 9 of 263 women (3%) undergoing D&E (unadjusted relative risk 6.9 [95% confidence interval 3.4–14.0]). When controlled for confounding, the adjusted risk ratio for labor induction was 8.5 (95% confidence interval 3.7–19.8) compared with D&E.
CONCLUSION: Dilation and evacuation is significantly safer and more effective than labor induction for second-trimester abortion for fetal indications. Bias and chance are unlikely explanations for these large discrepancies. Women facing this difficult decision should be offered a choice of methods and be provided information about their comparative safety and effectiveness.

3. Retrospective Cohort
Sonalkar, S. , Ogden, S. N., Tran, L. K. and Chen, A. Y. (2017), Comparison of complications associated with induction by misoprostol versus dilation and evacuation for second‐trimester abortion. Int J Gynecol Obstet, 138: 272-275. doi:10.1002/ijgo.12229
Abstract
OBJECTIVE:
To compare the frequency of complications between medical induction with misoprostol and dilation and evacuation (D&E) for second-trimester uterine evacuation.
METHODS:
In a retrospective cohort study, records were reviewed from all women who underwent second-trimester uterine evacuation between 14 and 24 weeks of pregnancy at an academic hospital in the USA from January 2007 to December 2008. Total complications and serious complications were compared between medical induction and D&E, and clinical covariates associated with complications were assessed.
RESULTS:
Overall, 465 women were included. At least one complication occurred in 28 (23.0%) of 122 women in the medical induction group, and 24 (7.0%) of 343 women in the D&E group (P<0.001). One or more serious complications occurred in 4 (3.3%) women undergoing medical induction and 5 (1.5%) undergoing D&E (P=0.251). Logistic regression analysis demonstrated that increasing pregnancy length (P=0.003) and medical induction (as compared with D&E; P=0.004) were associated with complications.
CONCLUSION:
Although D&E resulted in fewer overall complications as compared with medical induction, the rate of serious complications did not differ between the two procedures
PMID: 28585710 DOI: 10.1002/ijgo.12229

4. Retrospective Cohort
Whitley, Kari A. et al. (2011). Midtrimester dilation and evacuation versus prostaglandin induction: a comparison of composite outcomes. American Journal of Obstetrics & Gynecology, Volume 205, Issue 4, 386.e1 – 386.e7. DOI: https://doi.org/10.1016/j.ajog.2011.07.028
Abstract
OBJECTIVE:
The objective of the study was to determine the optimal procedure for midtrimester uterine evacuation.
STUDY DESIGN:
This was a retrospective cohort study of women undergoing midtrimester uterine evacuation by prostaglandin induction or dilation and evacuation (D&E). Primary outcome was composite complication, defined as any of the following: infection, need for additional surgery, unexpected admission or readmission, serious maternal morbidity, and/or maternal death.
RESULTS:
Two hundred twenty patients met inclusion criteria: 94 D&E and 126 induction. D&E was associated with less composite complications (15% vs 28%, P = .02), which persisted in adjusted analysis (adjusted odds ratio, 0.38; 95% confidence interval, 0.15-0.99; P = .05). Women in the induction group had higher rates of retained placenta requiring curettage (22% vs 2%, P = .01), whereas cervical injury was more common in the D&E group (5% vs 0%, P = .01). Median length of stay was significantly shorter in the D&E group (5.7 hours vs 28.4 hours, P < .001).
CONCLUSION:
Midtrimester D&E is associated with fewer complications than prostaglandin induction.
PMID: 22083061         DOI: 10.1016/j.ajog.2011.07.028

5. Randomized Controlled Trial
Kelly, T. , Suddes, J. , Howel, D. , Hewison, J. and Robson, S. (2010), Comparing medical versus surgical termination of pregnancy at 13–20 weeks of gestation: a randomised controlled trial. BJOG: An International Journal of Obstetrics & Gynaecology, 117: 1512-1520. doi:10.1111/j.1471-0528.2010.02712.x
Abstract
OBJECTIVE:
To compare the psychological impact, acceptability and clinical effectiveness of medical versus surgical termination of pregnancy (TOP) at 13-20 weeks of gestation.
DESIGN:
Randomised trial.
SETTING:
Large UK tertiary centre.
SAMPLE:
Women accepted for TOP at 13-20 weeks of gestation.
METHODS:
Medical TOP (MTOP) using mifepristone and misoprostol or surgical TOP (STOP) by vacuum aspiration at <15 weeks of gestation, and by dilatation and evacuation at 15 or more weeks of gestation.
MAIN OUTCOME MEASURES:
Distress 2 weeks after TOP, measured by the impact of events scale (IES), and acceptability, measured by the proportion of women who would opt for the same procedure again.
RESULTS:
One hundred and twenty two women were randomised: 60 to the MTOP group and 62 to the STOP group. Twelve women opted to continue their pregnancy. Follow-up rates were low (n=66/110; 60%). At 2 weeks post-procedure there was no difference in total IES score between groups. However, compared with women undergoing STOP, women undergoing MTOP had a higher score on the IES intrusion subscale (mean difference 6.6; 95% CI 1.4-11.8), and a higher score on the general health questionnaire (GHQ) (P=0.033). Women found STOP more acceptable: compared with MTOP, more women would opt for the same procedure again (100% versus 53%, P≤0.001), and fewer women found the experience to be worse than expected (0% versus 53%, P=0.001). Women who had MTOP experienced more bleeding (P=0.003), more pain on the day of the procedure (P=0.008), and more days of pain (P=0.020). Of the 107 women who declined to participate, 58 (67%) preferred a STOP.
CONCLUSIONS:
Randomised trials of women requesting midtrimester TOP are challenging. Women found STOP less painful and more acceptable than MTOP.
PMID: 20860598 DOI: 10.1111/j.1471-0528.2010.02712.x
6. Systematic Review
Lohr PA, Hayes JL, Gemzell-Danielsson K. Surgical versus medical methods for second trimester induced abortion. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD006714. DOI: 10.1002/14651858.CD006714.pub2
Abstract
BACKGROUND:
Determining the optimal method of performing second-trimester abortions is important, since they account for a disproportionate amount of abortion-related morbidity and mortality.
OBJECTIVES:
To compare surgical and medical methods of inducing abortion in the second trimester of pregnancy with regard to efficacy, side effects, adverse events, and acceptability.
SEARCH STRATEGY:
We identified trials using Pub Med, EMBASE, POPLINE, and the Cochrane Central Register of Controlled Trials (CENTRAL). We also searched the reference lists of identified studies, relevant review articles, book chapters, and conference proceedings for additional, previously unidentified studies. We contacted experts in the field for information on other published or unpublished research.
SELECTION CRITERIA:
Randomised trials comparing any surgical to any medical method of inducing abortion at >/= 13 weeks’ gestation were included.
DATA COLLECTION AND ANALYSIS:
We assessed the validity of each study using the methods suggested in the Cochrane Handbook. Investigators were contacted as needed to provide additional information regarding trial conduct or outcomes. Two reviewers abstracted the data. Odds ratios and 95% confidence intervals were calculated for dichotomous variables using RevMan 4.2. The trials did not have uniform interventions, therefore, we were unable to combine them into a meta-analysis.
MAIN RESULTS:
Two studies met criteria for this review. One compared dilation and evacuation (D&E) to intra-amniotic instillation of prostaglandin F(2) (alpha). The second study compared D&E to induction with mifepristone and misoprostol. Compared with prostaglandin instillation, the combined incidence of minor complications was lower with D&E (OR 0.17, 95% CI 0.04-0.65) as was the total number of minor and major complications (OR 0.12, 95% CI 0.03-0.46). The number of women experiencing adverse events was also lower with D&E than with mifepristone and misoprostol (OR 0.06, 95% CI 0.01-0.76). Although women treated with mifepristone and misoprostol reported significantly more pain than those undergoing D&E, efficacy and acceptability were the same in both groups. In both trials, fewer subjects randomised to D&E required overnight hospitalisation.
AUTHORS’ CONCLUSIONS:
Dilation and evacuation is superior to instillation of prostaglandin F(2) (alpha). The current evidence also appears to favour D&E over mifepristone and misoprostol, however larger randomised trials are needed.
PMID: 18254113 DOI: 10.1002/14651858.CD006714.pub2

7. Retrospective Observational Cohort Study
Shaw KA, Lerma K. Update on second-trimester surgical abortion. Curr Opin Obstet Gynecol 2016; 28:510-516. DOI: 10.1097/GCO.0000000000000318
PURPOSE OF REVIEW:
To review the recent literature on surgical second-trimester abortion, with specific attention to cervical preparation techniques.
RECENT FINDINGS:
Confirming previous studies, a recent retrospective observational cohort study, including 54 911 abortions, estimated the total abortion-related complication rate to be 0.41% for second-trimester or later procedures. Cervical preparation is known to reduce risks associated with second-trimester dilation and evacuation (D&E). When considering adjuncts to osmotic dilators for cervical preparation prior to D&E after 16 weeks, both misoprostol and mifepristone are effective alone and in combination or as adjuncts to osmotic dilators. Misoprostol consistently has been shown to cause more pain and cramping than placebo, but is an effective adjunct to osmotic dilators after 16 weeks. Although mifepristone has fewer side-effects, at its current price, it may not be as cost-effective as misoprostol.
SUMMARY:
Second-trimester abortion is safe. The use of mifepristone and misoprostol for second-trimester abortion has improved safety and efficacy of medical and surgical methods when used alone or in combination and as adjuncts to osmotic dilators. An important aspect of D&E, cervical preparation, is not a one-size-fits-all practice; the approach and methods are contingent on patient, provider and setting and should consider all the evidence-based options.
PMID: 27684047 DOI: 10.1097/GCO.0000000000000318

Summary of the Evidence:

Author (Date)	Level of Evidence	Sample/Setting (# of subjects/ studies, cohort definition etc. )	Outcome(s) studied	Key Findings	Limitations and Biases
American College of Obstetricians and Gynecologists 2019	Clinical Practice Guidelines	Clinical Practice Guidelines derived from evidence-based research for the medical and surgical methods of second-trimester termination	N/A   Evaluated the evidence-based research to formulate conclusions on the clinical practice for Second-Trimester Abortion	The following recommendations and conclusions are based on good and consistent scientific evidence (Level A): ●       Cervical preparation is recommended before D&E to decrease risk of cervical trauma. ●       Mifepristone followed in 24–48 hours by misoprostol is the most effective regimen for second-trimester medical abortion. ●       Misoprostol as a single agent is effective for medical abortion. ●       Administration of prophylactic antibiotics decreases the risk of infection after surgical abortion and, therefore, should be provided to all patients undergoing D&E. ●       Except for hysteroscopic sterilization, diaphragm, or cervical cap, all forms of contraception can be considered after second-trimester abortion and initiated on the day of the procedure. The following recommendations and conclusions are based on limited or inconsistent scientific evidence (Level B): ●       Dilation and evacuation is associated with fewer complications than medical abortion involving misoprostol regimens. ●       When there is a suspicion of abnormal placentation, D&E is the preferred abortion method, and preparations should be made for possible hemorrhage by ensuring the procedure is performed at an appropriate facility with accessibility to blood products, interventional radiology, and the capability to perform a hysterectomy if necessary. ●       The use of vasopressin in the paracervical block may decrease blood loss from D&E. ●                         Methylergonovine maleate is an appropriate first-line uterotonic agent unless contraindicated, as in patients with hypertension. Misoprostol is an effective agent in the setting of postabortion hemorrhage, and doses of 800–1,000 micrograms are recommended. ●       If refractory bleeding is thought to be due to atony or lower uterine segment bleeding, a Foley catheter or intrauterine balloon should be inserted to tamponade the endometrial cavity. ●       Because the risk of uterine rupture associated with prior cesarean delivery is similar to the risk among women without a prior cesarean delivery, guidelines support the safety of misoprostol specifically and medical abortion generally in women with one prior cesarean delivery. The following recommendations are based primarily on consensus and expert opinion (Level C): ●       In order to ensure access to D&E, residency training programs should offer integrated abortion training that includes second-trimester D&E. ●       All physicians should facilitate timely referrals for abortion care to reduce delays in accessing services. ●       Interventions to improve and facilitate early identification of pregnancy should be encouraged, including efforts to educate women about the signs and symptoms of pregnancy.	Clinical guidelines discuss high level findings and draw conclusions without including significant pathophysiologic details or personal experiences, which makes it challenging for a new (inexperienced provider)   Better tool for an experienced physician who can use it to provide the highest level of care with application of historical personal clinical experience VS. a new provider who does not have clinical experience to apply the guidelines in a practical setting without studying further and reviewing additional research   Guidelines are meant to provide overarching principles for practice but may not always be right for the individualized patient so provider must have the expereince to know when individualize care for the patient (in lieu of abiding by the guidelines)   Lower levels of evidence guiding practice based on consensus and expert opinion, if providers don’t utilize historical knowledge and practice a ‘recommendation’ at a lower level of evidence there may be unforseen outcomes the research didn’t predict, leading to negative outcomes for patients
Bryant AG, Grimes DA, Garrett JM, Stuart GS 2011	Retrospective Cohort	Retrospective analysis of second-trimester abortions for fetal anaomalies and fetal death comparing frequency of complications and effectiveness of abortions (surgical vs. medical)   399 women at the University of North Carolina Hospitals participated using CPT terminology codes for D&E / Medical management as well as diagnosis codes for fetal death and anomalies   Exclusion criteria included SROM, intrapartum fetal death (without anomaly) and onset of labor before the abortion   Complications documented in medical record were listed as primary outcome – allows for study to answer posed research question	To evaluate safety & effectiveness of dilation and evation and labor-induction abortion performed for fetal anomalies or fetal death in second trimester	D&E resulted in less morbidity than labor-induction when done for indications of fetal anomalies and fetal death – Safest method   –        24% of women in labor-induction group had one or more complications; 3% of women in D&E group had one or more complications –        Unadjusted RR for any complication in labor induction group compared with D&E was 6.9 (95% CI 3.4-14.0; P<.001) –        Adjusted RR for labor induction was 8.5 (95% CI 3.7-19.8; P< .001) –        Absolute risk reduction in morbidity 21% –        For every 5 patients undergoing labor induction, one suffered a complication that could have been avoided if D&E had been chosen instead (small number needed to harm) Complications differed by procedure type: –        MC in labor induction: retained placenta requiring D&C or manual removal (+Fever & Abx) –        D&E group complications: hospital admission, repeat aspiration or failed attempted D&E requiring labor induction)	Population evaluated were having abortions for known fetal anomalies and / or fetal death, whereas patient in clinical scenario did not have known fetal death when the decision to proceed with a D&E was made (ultimately patient fit selection criteria)   Relatively small population size, which makes it harder to apply findings to clinical settings (eligible patients may have been missed if data was miscoded or relevant data not abstracted) – authors note this is a sample size of convenience, if more patients had been included, it is possible the outcomes may have varied   Data derived from EMRs and standardized retrospectively, not the highest level of evidence on the pyramid and may not be substantiated in practice (findings consistent with other published data)   Given study is retrospective, it would be difficult to control other cofounding variables &/or comorbidities – researchers performed adjusted risk ration to aid in control   Possible selection bias as patients were not assigned to an abortion method but opted to the D&E or medical abortion   No follow up on patients done after discharge due to confidentiality
Sonalkar, S. , Ogden, S. N., Tran, L. K. Chen, A. Y. 2017	Retrospective Cohort	Retrospective cohort study of second-trimester uterine evacuation (between 14 and 24 weeks) at the University of California, LAMC   465 women (mean age 26.5 +/- 7 years) were included in the study –        D&E n=343 (1-2 days after cervical preparation with laminaria) –        Medical induction n=122 (serial doses of misoprostol)   Mean pregnancy length 19 +/- 3weeks   Retrospective chart review completed on patients between 1/1/07 – 12/31/08 – data extracted from records using ICD codes, CPT codes and operating room logs   Demographic data abstracted to aid with statistical analyses and logistical regression model (using SAS)   Complications abstracted for both routes: new infection, readmission, ED visits, retained products, blood loss, transfusion, ICU admission, cardiopulmonary arrest, detah	To compare frequency of complications between medical induction (with misoprostol) and dilation and evacuation for second-trimester uterine evacuation	D&E resulted in fewer overall odds of complications (compared to medical induction) – p <0.001 –        rate of serious complications did not differ between two procedures   Procedure type and length of pregnancy remained significant –        with each week of pregnancy, women were 27% more likely to have a complication, timely evacuation is recommended   D&E procedure was 61.5% less likely to have a complication than those who underwent medical induction –        23% of women experienced at least one complication in medical induction group –        7% of women in the D&E group experienced at least one complication (p< 0.001) –        One or more serious complication occurred in 3.3% of women undergoing medical induction –        1.5% of women undergoing D&E had one or more serious complication occur (p=0.251) –        Logistic regressions shows that greater gestation age (p=0.003) and medical induction (as compared with D&E; p=0.004) were associated with complications   MC complication among both procedures: infection (requiring antibiotics) –        medical induction had greater likelihood to be diagnosed with infection than those with D&E	Potential for selection bias, as a retrospective cohort study, patients selected their intervention (rather than having one assigned randomly)   Authors note, it was difficult to assess whether participants had previously sought out care at other institutions before LAMC –        if so, they could have received more education and guidance on a particular approach, further skewing study findings –        Additionally, prior complications could have been addressed and resurfaced at the time of delivery (or D&E) leading to complications   Demographic details were abstracted but no comparison of these details were done (BMI, race/ethnic origin, socioeconomic status)   Small sample size used in this study which makes it more challenging to apply the findings to clinical practice.   Retrospective study is challenging / limiting as it looks back on a population to see what was achieved with previous practices instead of setting out with intent to determine appropriate outcomes.
Whitley, Kari A. et al. 2011	Retrospective Cohort	Retrospective cohort study on all women with a planned midtrimester uterine evacuation procedure (13 weeks – 23w6days) at Leigh Valley Health Network (PA)   220 patients retrospectively identified using CPT and ICD codes as well as delivery logs and Reports of Induced Termineation of Pregnancy forms –        94 D&E –        126 induction   Exclusion criteria included: active labor and/or advanced cervical dilation, preexisting chorioamnionitis and pregnancies outside gestattional age range   Primary outcome evaluate was occurrence of a composite complication (infection requiring antibiotics, endometritis or sepsis, blood transfusion, need for additional surgery, unexpected admission / readmission for related complications, maternal morbidity & mortality) – can be used clinically for counseling patients on procedure risk   Secondary outcome: length of stay	To determine the optimal procedure for midtrimester uterine evacuation.	D&E is safer and more cost effective than induction   D&E associated with less composite complications than prostaglandin induction (15% vs 28%, P=0.02) –        Multivariate logsitc regression performed to control for potential confounders – data remains consistent and supported by adjusted analysis (adjusted odds ratio 0.38; 95% CI, 0.15-0.99; P=0.05) –        PROM had strongest association with morbidity, analysis repeated without PPROM patients and D&E remained associated with less composite complications (AOR 0.34; 95% CI 0.12-0.95; P = 0.04) –        Women in injudction grou had higher rates of retained placenta requiring currettage (22% vs. 2%, p=0.01) –        Cervical injury was more common in D&E group (5% vs 0%, p = 0.01)   Median length of stay was significantly shorter in the D&E group (5.7 hours vs. 28.4 hours; p <0.001)   No difference in serious complications (which were rare in both groups) – no maternal deaths	Although time period extended, change in providers at the beginning of time period resulted in a more standardized approach to process, which eliminated selection possibility from patients, potentially affecting results.   Results may be slightly higher than normal as LVHM serves as a referral center for patients with suspected fetal anomalies and/or pregnancy complications so women electing to have a second trimester pregnancy termination from surrounding areas come to this facility even if they would not normally deliver, potentially skewing results   Given the study was done retrospectively, the researchers weren’t able to account for all demographic differences that may have affected the final results (including age, insurace, race, ethnicity, likelihood of undergoing invasive testing)   Relatively small sample size tried to be adjusted with composite complications however doesn’t necessarily allow for clinical application   Women with known fetal anaomlies were encouraged to have inductions to allow for autopsies to obtain a diagnosis   Retrospective studies have information and selection bias   LVHM providers have option to opt out of caring for patients undergoing pregnancy termination (and more likely to opt out of learning a D&E procedure), limiting the number of providers able to perform the procedure safely and effectively –        results may not be comparable with other institutions with providers less expereinced in D&Es or with varying protocols
Kelly, T. Suddes, J. Howel, D. Hewison, J. Robson, S. 2010	Randomized Controlled Trial	RCT of Medical Termination of Pregnancy vs Surgical termination of Pregnancy between 13 weeks – 19 weeks, 6 days in Newcastle, England.   Exclusion criteria: fetal congenital abnormality and a medical disease precluding medical TOP, those unable to speak English were also excluded.   720 women given a patient information sheet, after decision to proceed with TOP –        research nurse answered questions and enrolled patients in study after explaining they were randomized to MTOP or STOP –        122 women enrolled –        60 to MTOP –        62 to STOP –        12 women decided to continue pregnancies (52 MTOP and 58 STOP) –        Women who declined were asked to state rationale   Gestational age confirmed with US BPD and again on day of procedure   Women in trial asked to return to hospital 14d s/p TOP for follow-up and questioned about: –        bleeding and pain   Primary outcome was IES (15-item scale) with seven intrusion and eight avoidance items used to measure stress reactions after traumatic events and has convergent validity   Secondary outcomes included: –        General health questionnaire –        HADS score for anxiety and depression –        Physical symptoms during/after procedure –        Complications –        Acceptability –        Satisfaction	To compare the psychological impact, acceptability and clinical effectiveness of medical versus surgical termination of pregnancy at 13-20 weeks of gestation.	Women seemed to prefer STOP –        majority of women were satisfied with the care received regardless of the procedure –        both MTOP or STOP should be offered as choices for women after 13 weeks of gestation   Mean IES-I score was higher for MTOP (difference = 6.6, 95% CI; 1.4-11.8), indicating ‘women had more intrusive thoughts about the procedure’ –        MTOP associated with more pain and bleeding and unexpected overnight stays   Mean IES total and IES-A scores were higher in the MTOP group –        lack statistical signifcance, wide 95% CI showed data consistent with large differences   Mean GHQ 12 scores higher after MTOP (adjusted difference 2.6, 95% CI 0.7-4.4)   Patients who underwent STOP would opt to have same procedure again 100 vs 53% (95% CI for difference 29-65% compared to patients who underwent MTOP procedure   MTOP patients described heavier bleeding (37 vs 4%, 95% CI for difference 14-52% for longer durations (difference in means 2.2 days 95% C, 0.4-4.5) than those who underwent STOP	Study completed in England so not as applicable to a clinical setting within the United States due to confounding environmental factors as well as medical practices that may differ between two nations   Small sample size included for randomization –        Patients that declined to be randomized did so indicating a strong preference for one procedure over the other   Study includes a smaller window of patients interms of the timing women could enroll (which naturally limits the number of women able to enroll in the study), whereas if they’d been involved in a different study they could have participated for another 4-5 weeks and still been considered second trimester evacuations. –        limited funding could not extend recruitment beyond 46 months to recruit a larger sample size   Limited availability of research nurse prevented researchers from meeting ~500 patients that were eligible for the study, with more patient enrollment, results may have varied. –        Small sample size 122 (of 720 eligible patients) enrolled. While an RCT is higher on the evidence chain the population size is still small making the data more difficult to translate to clinical setting   Only 66 women attended 2-week clinic follow-up or retruned questionnaire, unable to conduct finite results given approximately ½ the population is missing and results may vary if additional patitents had provided similar feedback –        potential for more data to be collected if researchers offered other means for patients to provide feedback
Lohr PA Hayes JL Gemzell-Danielsson K. 2008	Systematic Review	Review of PubMed, EMBASE, Popline and CENTRAL searching for randomized trials comparing any surgical to any medical metho of inducing abortion at >/= 13 weeks’ gestation –        validity assessed using methods suggested in Cochrane Handbook –        Investigators contacted as needed to provide additonal information regarding trial conduct or outcomes –        Two reviewers abstracted data –        Odds ratios and 95% CI calculated for dichotomous variables using RevMan4.2 –        Results were not combine into a meta-analysis   Two studies included in systematic review that met the proposed criteria. –        Total participants in both studies equal 100 –        Study 1: compared D&E to injecting drug into the pregnant womb –        Study 2: compared D&E to drugs taken by mouth and by vagina Top Outcome measures: 1.     Major complications 2.     Minor complications 3.     Side effects 4.     Pain 5.     Abortion completed with intended method 6.     Time to completed abortion 7.     Requirement for overnight hospitalization 8.     Hospital readmission 9.     Satisfaction and acceptability	To compare surgical and medical methods of inducing abortion in the second trimester of pregnancy with regard to efficacy, side effects, adverse events, and acceptability.	Study 1 – Dilation and evacuation is preferable to prostaglandin F2alpha instillation for second trimester abortion –        D&E also appears to be associated with fewer overall adverse events, side effects and pain than induction with mifepristone and misopristol –        Instillation of prostaglandin F2alpha compared to D&E, between 13-24 weeks, was associated with higher risk of serious complications (RR1.9, 95% CI 1.2-3.1) –        Women treated with misoprostol had a higher overall rate of complications compared to those undergoing D&E (22% vs 4%, p<0.001) + selection bias   Combination of major and minor complications was significantly lower in the D&E group (OR 0.12, 0.03-0.46)   Total number of women experiencing one or more adverse events was lower in the D&E group (OR 0.06,95%CI; 0.07-0.76)   Study 2 – Induction with mifepristone and misoprostol appears to be effective and acceptable as D&E however D&E is favoured over mifepristone and misoprostol –        more women undergoing induction experienced adverse events with induction (pain and side effects) (OR 0.06, 95%, CI 0.01-0.76) –        Combine incidence of minor complications lower with D&E (OR 0.17, 95% CI 0.04-0.65) as well as major complications (OR 0.12, 95% CI 0.03-0.46)   Both trials, fewer subjects randomized to D&E required overnight hospitalization.	Systematic review allows the research to sit high on the evidence pyramid but study only incorporated two subsequent studies to review with a total relatively small sample population, findings are statistically significant but from a small sample size makes them harder to apply in a clinical setting.   Study makes a comparison of instillation techniques to D&E, which are not used in modern abotion care, findings are not as useful and applicable to clinical practice –        Limited availability of D&E compared to current abortive methods.   Selection bias was evident in certain studies as induction group participants were of significantly higher gestational age and thus altering the results so they’re not applicable to the broader population in clinical practice   Study is outdated and review completed by British researchers – practices likely differ between nations making it challenging to apply findings to the clinical setting                 More studies with modern medicines used for abortion after 3 months of pregnancy are needed Trials of adequate power are needed to compare currently used medical and surgical methods of abortion in the second trimester
Shaw KA, Lerma K. 2016	Retrospective Observational Cohort Study	Reviewed 54,911 abortions retrospectively, noting the evolution of medical and surgical abortive methods   Evaluates and provides detailing of abortion in second trimester –        Induction abortion –        Dilation and evacuation –        Induction vs. Dilation and evacuation Evaluates cervical prepartion –        Osmotic dilators alone –        Pharmacologic agents compared with osmotic dilators –        Pharmacologic agents as adjuncts to osmotic dilators   Operative Technique Evaluated	To review the recent literature on surgical second-trimester abortion, with specific attention to cervical preparation techniques.	Second-trimester abortion safe and effective –        Complication rate 0.41% for second-trimester or later procedures   D&E can be cost-effective and efficient and generally most common means of second-trimester abortion in US –        D&E risk increases as gestational age increases –        Associated with lower rates of morbidity & mortality   Introduction of mifepristone and misoprostol to second-trimester abortion has improved the safety & efficacy of both medical and surgical methods –        Introduction of mifepristone to second-trimester medical abortion improved safety and efficacy, reducing abortion times by nearly 50%   Cervical prepartion methods shown to decrease risk associated with D&E –        Cervical preparation is KEY aspect of D&E provision, will be both patient and provider dependent –        Cervical prepartion reduces the risk of the most common complications of D&E (cervical laceration and uterine perforation) –        Both misoprostol and mifepristone are effective alone and in combination –        Misoprostol consistently has been shown to cause more pain and cramping than placebo (use pain management!) –        Mifepristone has fewer side-effects but may be cost-effective	Study is a review of retrospective studies – not a retrospective study itself; however there is not an analysis or systematic data that supports the findings beyond what the other studies being refernced, no meta analysis done, more difficult to apply clinically. Study addresses the processes hollistically, without comparing them in detail with supporting data. Good article to read to get an overview of the topic and the different options available. Highlevel review.

Conclusion(s):
The American College of Obstetricians and Gynecologists conclude dilation and evacuation is associated with fewer complications than medical induction using misoprostol regimens. That said, ACOG reports misoprostol is effective for medical abortion as a single agent. Experts note that both abortion options may not be available in all areas in the United States and providers should consider safety, effectiveness, cost, logistics, patient preference and indication before making a decision as the the appropaiate approach for a second-trimester abortion as they are deeply personal and can impact outcomes.

Bryant AG. et al found dilation and evacuation resulted in less morbidity than medical labor-induction when done for indications of fetal anomalies and fetal death. The authors found there were approximately five times as many complications for patients undergoing medical labor induction as there were if they’d undergone a dilation and evacuation, with an adjusted risk reduction in morbidity noted at 21% (for D&E).  That said, the study was completed retrospectively with limited follow up done after initial discharge from the hospital, prompting the need for further research to evaluate patients post-discharge.

Sonalkar, S. et. al’s research finds that dilation and evacuation resulted in fewer overall complications when compared to medical induction, while the rate of serious complications did not differ between the two treatments.  These authors highlighted the significance of gestational age playing affecting outcomes and reported with each week of pregnancy women were more likely to have a complication.  Ultimately, further research is required, with larger sample sizes and greater patient education, to effectively make long-term recommendations to drive practice.

Whitley, Kari A. et al. found that dilation and evacuation is both safer and more cost effective than induction and confirmed after a multivariate logistic regression was performed.  The authors found that length of stay was shorter for the D&E group but there was no difference in serious complications (i.e. maternal deaths) between the two interventions.  Patients treated in this hospital system were counseled to have medical inductions if they have known fetal anomalies, which may alter the results, indicating that further research is required to eliminate biases.

Kelly, T. et. al, the only Randomized Controlled Trial included, determined that women preferred the surgical termination of pregnancy (D&E) over medical termination of pregnancy based on questionnaires/surveys completed by participants.  The authors found that patients who were randomized into the medical termination of pregnancy group experienced more pain, bleeding and unexpected overnight stays.  These researchers only evaluated patients through 19 weeks, 6 days and not the full second trimester, which naturally eliminates a significant portion of the population.  Further research is required with an adequately powered study given the limited results discussed.

Lohr PA et. al, all British researchers, completed a systematic review, which evaluated two studies.  Study one found dilation and evacuation is preferable to prostaglandin F2 alpha instillation for second trimester abortion and study two noted dilation and evacuation is favored over mifepristone / misoprostol inductions, given the adverse events associated with induction.  Additional research is needed to validate these findings given the limited subject pools and advancements in medicine that may ultimately impact the resulting data.

Shaw KA et. al review retrospective studies and discuss the literature findings and how second-trimester abortions are done in practice.  With the largest sample size, the authors note the evolution of both medical and surgical abortions and highlight the various methods for second-term abortions, ultimately dictating it safe and effective.  The researchers note that dilation and evacuation is the most common means of second-trimester abortion and the inclusion of mifepristone and misoprostol has improved the safety & efficacy of both medical and surgical abortions.  This article is a high level review that references the various procedures but provides only limited supporting data.  Additional actionable research is required to substantiate the claims made in this article.

Similarly across all articles reviewed, there is a common ground that both dilation and evacuation as well as medical induction with misoprostol is safe and effective for second term abortions. As is the case in any medical intervention, evaluating risks and benefits is essential to understanding the needs of the patients but also comorbidities that may affect outcomes. A large majority of the studies are completed retrospectively, which inherently has selection bias. On the other hand the systematic review and randomized controlled trial included were completed in the British Health Care system, as they would not be approved by the NIH in the United States, given the personal nature of the subject and unknown outcomes. Further research is needed to better understand how the advances in moder medicine affect the outcomes for patients who undergo second trimester abortions. As noted, a majority of the articles provide insight highlighting D&E is superior to medical induction; however both interventions are safe to use for second trimester abortions. That said, these articles evaluate very small sample sizes and research / trials of adequate power are necessary to dictate clinical practice.

 

Clinical Bottom Line:

Please include an assessment of the following:
– Weight of the evidence – summarize the weaknesses/strengths of the articles and explain how they factored into your clinical bottom line (this may recap what you discussed in the criteria for choosing the articles)
– Magnitude of any effects
– Clinical significance (not just statistical significance)
– Any other considerations important in weighing this evidence to guide practice – If the evidence you retrieved was not enough to conclude an answer to the question, discuss what aspects still need to be explored and what the next studies will have to answer/provide (e.g. larger number, higher level of evidence, answer which sub-group benefits, etc)

Similarly to any medical decision, the decision to move forward with a second trimester abortion is a very personal one. One that should only be decided upon once a patient is educated on the various interventions available. A patients comorbidities must be taken into account when discussing the treatment options to ensure there is an understanding as to the different effects that may result from surgical or medical termination of pregnancy. When selecting articles, the goal was to include the highest level of evidence available within a 10 year period, which allows for the evidence to be transferrable to clinical practice and applicable to the patient who prompted the search.

Clinical guidelines in this particular instance would provide an excellent starting point given the scientific data that suppports the recommendations as well as the breakdown of evidence that backs the findings. These clinical guidelines highlight the overarching takeaways and provide levels of evidence for which scientific data support the recommendations proposed. The recommendations are drawn from extensive, statistically significant data, and meant to guide practitioners trained in the interventions. Clinical guidelines are meant for providers who are experienced in their field and have bakground knowledge and have sound understand of the pathophysiology of the processes, which they can then use to apply these recommenations into practice. I would weight the clinical guidelines amongst the highest in my evidence given the data is supported by the experts in the field and substantive research is completed to keep these clinical guidelines updated with modern medicine.

For the most part, the studies available from the US are retrospective studies that included patients that had undergone second trimester abortions and evaluated the likelihood of complications following the respective intervention. Retrospective studies are beneficial in that they can be used to evaluate historical outcomes to guide future practices; however, there is an inherit selection bias based on the retrospective nature of the study, which researchers / reviewers should acknowledge. I would weigh the three Retrospective Cohorts completed in the US second to the Clinical Guidelines and above the systematic review and randomized controlled trial and retrospective observational cohort study. The US retrospective studies provided substantive, clinically significant, data that directed the clinical bottom highlighting the fact that Dilation and Evacuation results in less complications / morbidity than medical induction of pregnancy, yielding better maternal outcomes. Within the three articles, I would weigh the Bryant AG. et al and Sonalkar, S. et. al articles above the Whitley, Kari A. et al article, as they have larger sample sizes and directly address the posed question. The Sonalkar, S. et. al had an inconsistency in the size of the sample groups, but the researchers completed a logistical regression to verify their findings. The Whitley, Kari A. et al. article counseled patients to undergo medical abortions for the ability to have an autopsy post-mortem and accepted referrals from other hospitals, which may have skewed the results / brought patients to the hospital that would not have otherwise presented for evaluation. Interestingly the Whitley, Kari A. et al. addressed the associated costs between the two interventions, and although it wasn’t a part of the resesarch question, provided an additional layer of context, noting the dilation and evacuation is more cost effective. Ultimately, the three articles have the same conclusion, and were forthcoming with their limitations. Although they are lower on the evidence pyramid than systematic reviews / meta analsyses, the researchers provide sound results that help direct clinical practice.

Given we are practicing medicine in the United States, I was looking to solely include articles that evaluated / studied patients in the United States as well. That said, the laws and legal issues surrounding abortion in the US prohibit significant research from obtaining NIH approval from a research perspective, prompting me to include studies from the UK as a reference point. The effects of such a study, in the US, would weigh heavily in the political / social environment and the findings would be dissected for any flaw in the methods, though the magnitude would be of great impact. In the United States, researchers would never be permitted ethically to randomly assign patients to surgical or medical abortions given the personal nature of the decision and legal statutes involved, making if difficult to include any Randomized Controlled Trials from the US. Studies should also acknowledge the legal / state regulations that prevent some patients from having a second trimester abortion, requiring patients to travel to other states. Furthermore, it is important to acknowledge that some rural areas in America do not have providers trained to complete the surgical termination of pregnancy, which either eliminates it as an option, or again, requires the patient to travel to obtain the procedure. Finally, it is imperative to note that many trained providers may opt out of performing a termination of pregnancy, whether medically induced or completed surgically, for moral or religious reasons, making it difficult for patients in remote areas to obtain adequate care. Many of the articles touch upon these points but the retrospective studies were only looking at locations where these procedures were performed, eliminating these cofounding variables.

Kelly, T. et. al evaluates the complication rates for patients undergoing medical and surgical abortions in the second trimester by randomized controlled trial in England, while Lohr PA et. al, British authors, completed a systematic review of two articles to apply the findings to the British National Health Service. These articles provide research at the highest level on the evidence pyramid, which is why they were included, and evaluate findings which directly answer the posed question. That said, the British National Healthcare System differs greatly from healthcare in the United States and these environmental (and regulatory) factors prompt me to weigh these articles below the retrospective studies completed in the US, which is lower than I normally would weigh them. Lohr PA et. al evaluate ‘archaic’ abortion procedures with their review of medical instillation; but acknowlege that studies using modern medicine are necessary to evaluate the efficacy and safety of second trimester abortion.    Furhtermore, while these studies both contribute to the limited reesearch available they emphasize the small sample sizes used in their studies, calling for more research to be done at greater powers with the goal of providing data that is truly applicable to clinical practice. These articles may be helpful in a clinical / research setting to help drive further research but the statistical data isn’t useful in American maternal medicine.

While Shaw KA et. al was technically a retrospective observational cohort study, I would weigh it the lowest of all of the articles submitted for inclusion. The article presented a strong abstract with limited statistical data to support their findings. That said, the researchers collectively review more than 50,000 cases, which is the largest sample size and another reason the article was ultimately included. Shaw and team do address the research question and review various methods of second trimester abortion, there is no statistical significance provided to help substantiate the findings. The article is sound for providing background data and information for someone interested but does not provide results other than citations of other researchers work and provides limited data on a comparison between the medical and surgical second trimester abortion.

Abortion in the United States is a hot topic in the ever changing political climate. Second-trimester abortion elevates that discussion given the gestational age of the fetus and viability outside the womb. There are a multitude of tiers that must be taken into consideration given the complexity of this topic. Not only is there the medical data to dissect but also the personal, emotional, religious and moral beliefs of the patient and the provider that may dictate outcomes. The research questions which method of abortion, surgical or medical termination of pregnancy awards the best maternal outcomes. Historically evaluating scenarios where one intervention was selected over another allows for effective analysis of these outcomes, which helps derive decisions that direct clinical practice. That said, further research needs to be done, at higher levels and greater powers of evidence to determine which method of abortion yields better maternal outcomes, while accounting for the personal nature of the decision as well as other comorbidities that may direct a decision. A systematic review of the retrospective data could provide findings that were not noted across the smaller scale studies. Greater sample sizes should be included to allow for the transferability of these findings to modern medical practice.

After reviewing the available data, the clinical bottom line derived from the articles indicate that both medical and surgical termination of pregnancies should be offered to patients who wish to undergo second-trimester abortions. However, it is important to note, at a statistically significant level, dilation and evacuation is associated with fewer complications yielding safer more effective maternal outcomes. Regardless of findings, individuals have their own very personal beliefs about this topic. As providers it is essential we share the relevant data with patients and ensure they are well informed to make the best decision for them personally, a decision that is rooted in scientific data and results.