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Contraception: X 2020Mifepristone and misoprostol are recommended for second-trimester medical abortion, but consensus is unclear on the ideal regimen. (Review)
Review
BACKGROUND
Mifepristone and misoprostol are recommended for second-trimester medical abortion, but consensus is unclear on the ideal regimen.
OBJECTIVES
The objectives were to systematically review randomized controlled trials (RCTs) investigating efficacy, safety and satisfaction of medical abortion at ≥ 12 weeks' gestation.
DATA SOURCES
We searched PubMed, Popline, Embase, Global Index Medicus, Cochrane Controlled Register of Trials and International Clinical Trials Registry Platform from January 2008 to May 2017.
STUDY ELIGIBILITY PARTICIPANTS AND INTERVENTIONS
We included RCTs on medical abortion at ≥ 12 weeks' gestation using mifepristone and/or misoprostol. We excluded studies with spontaneous abortion, fetal demise and mechanical cervical ripening and those not reporting ongoing pregnancy (OP).
STUDY APPRAISAL AND SYNTHESIS METHODS
After extracting prespecified data and assessing risk of bias in accordance with the Cochrane handbook, we used Revman5 software to combine data and GRADE to assess certainty of evidence.
RESULTS
We included 43 of the 1894 references identified. Combination mifepristone-misoprostol had lower rates of OP [risk ratio (RR) 0.12, 95% confidence interval (CI) 0.04-0.35] vs. misoprostol only. A 24-h interval between mifepristone and misoprostol had lower OP rate at 24 h than simultaneous dosing (RR 3.13, 95% CI 1.23-7.94). Every 3-h dosing had lower OP rate at 48 h (RR 0.39, 95% CI 0.17-0.88).
LIMITATIONS
Direct comparisons of buccal misoprostol to sublingual or vaginal routes after mifepristone were limited. Evidence from clinical trials on how to best manage women with prior uterine incisions was lacking.
CONCLUSION
Our analysis supports the use of mifepristone 200 mg 1 to 2 days before misoprostol 400 mcg vaginally every 3 h at ≥ 12 weeks' gestation.
IMPLICATIONS
Where available, providers should use mifepristone plus misoprostol for second-trimester medical abortion. Vaginal misoprostol appears to be most efficacious with fewest side effects, but sublingual and buccal routes are also acceptable.
PubMed: 32954250
DOI: 10.1016/j.conx.2020.100037 -
PloS One 2020There are concerns about the quality of medicines available in low- and middle-income countries (LMIC) to manage hemorrhage, pre-eclampsia/eclampsia and sepsis. We aimed...
BACKGROUND
There are concerns about the quality of medicines available in low- and middle-income countries (LMIC) to manage hemorrhage, pre-eclampsia/eclampsia and sepsis. We aimed to identify, critically appraise, and synthesize the findings of studies on the quality of these three types of medicines available in LMIC.
METHODS
This systematic review searched Medline, EMBASE and LILACS (from inception to 25 May 2020) for studies on the quality of selected medicines available in LMIC that provided at least the amount of active pharmaceutical ingredient. We contacted study authors for additional information. We excluded simulation studies. We used the MEDQUARG tool to assess study quality. The main outcome was the prevalence of failed samples.
FINDINGS
We identified 9699 unique citations and included 34 studies (3159 samples from 40 countries) in the review. Most studies (65%) had low quality (scores <6/12). Overall, 48.9% of 1890 uterotonic samples (19 studies) failed quality tests; failures rates were 75% for ergometrine and nearly 40% each for oxytocin and misoprostol. The overall prevalence of failed injectable antibiotics (1090 samples, 18 studies) was 13.4%, ranging from 2.9% for injectable metronidazole (34 samples, 3 studies) to 16.0% for cefazolin (449 samples, 2 studies). The prevalence of low quality magnesium sulphate (179 samples, 2 studies) was 3.4%. We did not find any studies on the quality of carbetocin, tranexamic acid, or clindamycin.
CONCLUSIONS
There is a widespread problem with the quality of medicines used to manage life-threatening maternal conditions in LMIC. This can be a contributing factor to high maternal mortality rates in these regions.
Topics: Developing Countries; Female; Humans; Pregnancy; Pregnancy Complications; Quality of Health Care
PubMed: 32649710
DOI: 10.1371/journal.pone.0236060 -
BMC Women's Health Jul 2020A wide range of drugs have been studied for first trimester medical abortion. Studies evaluating different regimens, including combination mifepristone and misoprostol...
BACKGROUND
A wide range of drugs have been studied for first trimester medical abortion. Studies evaluating different regimens, including combination mifepristone and misoprostol and misoprostol alone regimens, show varying results related to safety, efficacy and other outcomes. Thus, the objectives of this systematic review were to compare the safety, effectiveness and acceptability of medical abortion and to compare medical with surgical methods of abortion ≤63 days of gestation.
METHODS
Pubmed and EMBASE were systematically searched from database inception through January 2019 using a combination of MeSH, keywords and text words. Randomized controlled trials on induced abortion at ≤63 days that compared different regimens of medical abortion using mifepristone and/or misoprostol and trials that compared medical with surgical methods of abortion were included. We extracted data into a pre-designed form, calculated effect estimates, and performed meta-analyses where possible. The primary outcomes were ongoing pregnancy and successful abortion.
RESULTS
Thirty-three studies composed of 22,275 participants were included in this review. Combined regimens using mifepristone and misoprostol had lower rates of ongoing pregnancy, higher rates of successful abortion and satisfaction compared to misoprostol only regimens. In combined regimens, misoprostol 800 μg was more effective than 400 μg. There was no significant difference in dosing intervals between mifepristone and misoprostol and routes of misoprostol administration in combination or misoprostol alone regimens. The rate of serious adverse events was generally low.
CONCLUSION
In this systematic review, we find that medical methods of abortion utilizing combination mifepristone and misoprostol or misoprostol alone are effective, safe and acceptable. More robust studies evaluating both the different combination and misoprostol alone regimens are needed to strengthen existing evidence as well as assess patient perspectives towards a particular regimen.
Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First
PubMed: 32635921
DOI: 10.1186/s12905-020-01003-8 -
The Cochrane Database of Systematic... Jul 2020Primary postpartum haemorrhage (PPH) is commonly defined as bleeding from the genital tract of 500 mL or more within 24 hours of birth. It is one of the most common...
BACKGROUND
Primary postpartum haemorrhage (PPH) is commonly defined as bleeding from the genital tract of 500 mL or more within 24 hours of birth. It is one of the most common causes of maternal mortality worldwide and causes significant physical and psychological morbidity. An earlier Cochrane Review considering any treatments for the management of primary PPH, has been split into separate reviews. This review considers treatment with mechanical and surgical interventions.
OBJECTIVES
To determine the effectiveness and safety of mechanical and surgical interventions used for the treatment of primary PPH.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (26 July 2019) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of mechanical/surgical methods for the treatment of primary PPH compared with standard care or another mechanical/surgical method. Interventions could include uterine packing, intrauterine balloon insertion, artery ligation/embolism, or uterine compression (either with sutures or manually). We included studies reported in abstract form if there was sufficient information to permit risk of bias assessment. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion and risk of bias, independently extracted data and checked data for accuracy. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
We included nine small trials (944 women) conducted in Pakistan, Turkey, Thailand, Egypt (four trials), Saudi Arabia, Benin and Mali. Overall, included trials were at an unclear risk of bias. Due to substantial differences between the studies, it was not possible to combine any trials in meta-analysis. Many of this review's important outcomes were not reported. GRADE assessments ranged from very low to low, with the majority of outcome results rated as very low certainty. Downgrading decisions were mainly based on study design limitations and imprecision; one study was also downgraded for indirectness. External uterine compression versus normal care (1 trial, 64 women) Very low-certainty evidence means that we are unclear about the effect on blood transfusion (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.66 to 8.23). Uterine arterial embolisation versus surgical devascularisation plus B-Lynch (1 trial, 23 women) The available evidence for hysterectomy to control bleeding (RR 0.73, 95% CI 0.15 to 3.57) is unclear due to very low-certainty evidence. The available evidence for intervention side effects is also unclear because the evidence was very low certainty (RR 1.09; 95% CI 0.08 to 15.41). Intrauterine Tamponade Studies included various methods of intrauterine tamponade: the commercial Bakri balloon, a fluid-filled condom-loaded latex catheter ('condom catheter'), an air-filled latex balloon-loaded catheter ('latex balloon catheter'), or traditional packing with gauze. Balloon tamponade versus normal care (2 trials, 356 women) One study(116 women) used the condom catheter. This study found that it may increase blood loss of 1000 mL or more (RR 1.52, 95% CI 1.15 to 2.00; 113 women), very low-certainty evidence. For other outcomes the results are unclear and graded as very low-certainty evidence: mortality due to bleeding (RR 6.21, 95% CI 0.77 to 49.98); hysterectomy to control bleeding (RR 4.14, 95% CI 0.48 to 35.93); total blood transfusion (RR 1.49, 95% CI 0.88 to 2.51); and side effects. A second study of 240 women used the latex balloon catheter together with cervical cerclage. Very low-certainty evidence means we are unclear about the effect on hysterectomy (RR 0.14, 95% CI 0.01 to 2.74) and additional surgical interventions to control bleeding (RR 0.20, 95% CI 0.01 to 4.12). Bakri balloon tamponade versus haemostatic square suturing of the uterus (1 trial, 13 women) In this small trial there was no mortality due to bleeding, serious maternal morbidity or side effects of the intervention, and the results are unclear for blood transfusion (RR 0.57, 95% CI 0.14 to 2.36; very low certainty). Bakri balloon tamponade may reduce mean 'intraoperative' blood loss (mean difference (MD) -426 mL, 95% CI -631.28 to -220.72), very low-certainty evidence. Comparison of intrauterine tamponade methods (3 trials, 328 women) One study (66 women) compared the Bakri balloon and the condom catheter, but it was uncertain whether the Bakri balloon reduces the risk of hysterectomy to control bleeding due to very low-certainty evidence (RR 0.50, 95% CI 0.05 to 5.25). Very low-certainty evidence also means we are unclear about the results for the risk of blood transfusion (RR 0.97, 95% CI 0.88 to 1.06). A second study (50 women) compared Bakri balloon, with and without a traction stitch. Very low-certainty evidence means we are unclear about the results for hysterectomy to control bleeding (RR 0.20, 95% CI 0.01 to 3.97). A third study (212 women) compared the condom catheter to gauze packing and found that it may reduce fever (RR 0.47, 95% CI 0.38 to 0.59), but again the evidence was very low certainty. Modified B-Lynch compression suture versus standard B-Lynch compression suture (1 trial, 160 women) Low-certainty evidence suggests that a modified B-Lynch compression suture may reduce the risk of hysterectomy to control bleeding (RR 0.33, 95% CI 0.11 to 0.99) and postoperative blood loss (MD -244.00 mL, 95% CI -295.25 to -192.75).
AUTHORS' CONCLUSIONS
There is currently insufficient evidence from RCTs to determine the relative effectiveness and safety of mechanical and surgical interventions for treating primary PPH. High-quality randomised trials are urgently needed, and new emergency consent pathways should facilitate recruitment. The finding that intrauterine tamponade may increase total blood loss > 1000 mL suggests that introducing condom-balloon tamponade into low-resource settings on its own without multi-system quality improvement does not reduce PPH deaths or morbidity. The suggestion that modified B-Lynch suture may be superior to the original requires further research before the revised technique is adopted. In high-resource settings, uterine artery embolisation has become popular as the equipment and skills become more widely available. However, there is little randomised trial evidence regarding efficacy and this requires further research. We urge new trial authors to adopt PPH core outcomes to facilitate consistency between primary studies and subsequent meta-analysis.
Topics: Bias; Blood Transfusion; Female; Hemostasis, Surgical; Hemostatic Techniques; Humans; Hysterectomy; Postpartum Hemorrhage; Pressure; Randomized Controlled Trials as Topic; Suture Techniques; Uterine Artery Embolization; Uterine Balloon Tamponade
PubMed: 32609374
DOI: 10.1002/14651858.CD013663 -
The Cochrane Database of Systematic... Jun 2020Advance community distribution of misoprostol for preventing or treating postpartum haemorrhage (PPH) has become an attractive strategy to expand uterotonic coverage to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Advance community distribution of misoprostol for preventing or treating postpartum haemorrhage (PPH) has become an attractive strategy to expand uterotonic coverage to places where conventional uterotonic use is not feasible. However, the value and safety of this strategy remain contentious. This is an update of a Cochrane Review first published in 2012.
OBJECTIVES
To assess the effectiveness and safety of the strategy of advance misoprostol distribution to pregnant women for the prevention or treatment of PPH in non-facility births.
SEARCH METHODS
For this update, we searched the Cochrane Pregnancy and Childbirth Trial Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (19 December 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomised, cluster-randomised or quasi-randomised controlled trials of advance misoprostol distribution to pregnant women compared with usual (or standard) care for the prevention or treatment of PPH in non-facility births. We excluded studies without any form of random design and those that were available in abstract form only.
DATA COLLECTION AND ANALYSIS
At least two review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias in included studies. Two review authors independently assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
Two studies conducted in rural Uganda met the inclusion criteria for this review. One was a stepped-wedge cluster-randomised trial (involving 2466 women) which assessed the effectiveness and safety of misoprostol distribution to pregnant women compared with standard care for PPH prevention during non-facility births. The other study (involving 748 women) was a pilot individually randomised placebo-controlled trial which assessed the logistics and feasibility of community antenatal distribution of misoprostol, as well as the effectiveness and safety of self-administration of misoprostol for PPH prevention. Only 271 (11%) of women in the cluster-randomised trial and 299 (40%) of the women in the individually randomised trial had non-facility births. Data from the two studies could not be meta-analysed as the data available from the stepped-wedge trial were not adjusted for the study design. Therefore, the analysed effects of advance misoprostol distribution on PPH prevention largely reflect the findings of the placebo-controlled trial. Neither of the included studies addressed advance misoprostol distribution for the treatment of PPH. Primary outcomes Severe PPH was not reported in the studies. In both the intervention and standard care arms of the two studies, no cases of severe maternal morbidity or death were recorded among women who had a non-facility birth. Secondary outcomes Compared with standard care, it is uncertain whether advance misoprostol distribution has any effect on blood transfusion (no events, 1 study, 299 women), the number of women not using misoprostol (2% in the advance distribution group versus 4% in the usual care group; risk ratio (RR) 0.50, 95% confidence interval (CI) 0.13 to 1.95, 1 study, 299 women), the number of women not using misoprostol correctly (RR 4.86, 95% CI 0.24 to 100.46, 1 study, 290 women), inappropriate use of misoprostol (RR 4.97, 95% CI 0.24 to 102.59, 1 study, 299 women) or maternal transfer or referral to a health facility (RR 0.66, 95% CI 0.11 to 3.91, 1 study, 299 women). Compared with standard care, it is uncertain whether advance misoprostol provision increases the number of women experiencing minor adverse effects: shivering/chills (RR 1.84, CI 95% 1.35 to 2.50, 1 study, 299 women), fever (RR 1.87, 95% CI 1.16 to 3.00, 1 study, 299 women), or diarrhoea (RR 3.92, 95% CI 0.44 to 34.64, 1 study, 299 women); major adverse effects: placenta retention (RR 1.49, 95% CI 0.25 to 8.79, 1 study, 299 women) or hospital admission for longer than 24 hours (RR 0.99, 95% CI 0.66 to 15.73, 1 study, 299 women) after non-facility birth. For all the outcomes included in the 'Summary of findings' table, we assessed the certainty of the evidence as very low, according to GRADE criteria.
AUTHORS' CONCLUSIONS
Whilst it might be considered reasonable and feasible to provide advance misoprostol to pregnant women where there are no suitable alternative options for the prevention or treatment of PPH, the evidence on the benefits and harms of this approach remains uncertain. Expansion of uterotonic coverage through this strategy should be cautiously implemented either in the context of rigorous research or with targeted monitoring and evaluation of its impact.
PubMed: 35819305
DOI: 10.1002/14651858.CD009336.pub2 -
International Journal of Environmental... Mar 2020Currently, there is no meta-analysis comparing intravaginal misoprostol plus intracervical Foley catheter versus intravaginal misoprostol alone for term pregnancy... (Meta-Analysis)
Meta-Analysis
Currently, there is no meta-analysis comparing intravaginal misoprostol plus intracervical Foley catheter versus intravaginal misoprostol alone for term pregnancy without identifying risk factors. Therefore, the purpose of this study is to conduct a systematic review and meta-analysis of randomized control trials (RCTs) comparing concurrent intravaginal misoprostol and intracervical Foley catheter versus intravaginal misoprostol alone for cervical ripening. We systematically searched Embase, Pubmed, and Cochrane Collaboration databases for randomized controlled trials (RCTs) comparing intracervical Foley catheter plus intravaginal misoprostol and intravaginal misoprostol alone using the search terms "Foley", "misoprostol", "cervical ripening", and "induction" up to 29 January 2019. Data were extracted and analyzed by two independent reviewers including study characteristics, induction time, cesarean section (C/S), clinical suspicion of chorioamnionitis, uterine tachysystole, meconium stain, and neonatal intensive care unit (NICU) admissions. Data was pooled using random effects modeling and calculated with risk ratio (RR) and 95% confidence interval (CI). Pooled analysis from eight studies, including 1110 women, showed that labor induction using a combination of intracervical Foley catheter and intravaginal misoprostol decreased induction time by 2.71 h (95% CI -4.33 to -1.08, = 0.001), as well as the risk of uterine tachysystole and meconium staining (RR 0.54, 95% CI 0.30-0.99 and RR 0.48, 95% CI 0.32-0.73, respectively) significantly compared to those using intravaginal misoprostol alone. However, there was no difference in C/S rate (RR 0.93, 95% CI 0.78-1.11) or clinical suspicion of chorioamnionitis rate (RR 1.22, CI 0.58-2.57) between the two groups. Labor induction with a combination of intracervical Foley catheter and intravaginal misoprostol may be a better choice based on advantages in shortening induction time and reducing the risk of uterine tachysystole and meconium staining compared to intravaginal misoprostol alone.
Topics: Administration, Intravaginal; Catheterization; Cervical Ripening; Cesarean Section; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 32168947
DOI: 10.3390/ijerph17061825 -
The Cochrane Database of Systematic... Mar 2020The advent of medical abortion has improved access to safe abortion procedures. Medical abortion procedures involve either administering mifepristone followed by... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The advent of medical abortion has improved access to safe abortion procedures. Medical abortion procedures involve either administering mifepristone followed by misoprostol or a misoprostol-only regimen. The drugs are commonly administered in the presence of clinicians, which is known as provider-administered medical abortion. In self-administered medical abortion, drugs are administered by the woman herself without the supervision of a healthcare provider during at least one stage of the drug protocol. Self-administration of medical abortion has the potential to provide women with control over the abortion process. In settings where there is a shortage of healthcare providers, self-administration may reduce the burden on the health system. However, it remains unclear whether self-administration of medical abortion is effective and safe. It is important to understand whether women can safely and effectively terminate their own pregnancies when having access to accurate and adequate information, high-quality drugs, and facility-based care in case of complications.
OBJECTIVES
To compare the effectiveness, safety, and acceptability of self-administered versus provider-administered medical abortion in any setting.
SEARCH METHODS
We searched Cochrane Central Register of Controlled Trials, MEDLINE in process and other non-indexed citations, Embase, CINAHL, POPLINE, LILACS, ClinicalTrials.gov, WHO ICTRP, and Google Scholar from inception to 10 July 2019.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and prospective cohort studies with a concurrent comparison group, using study designs that compared medical abortion by self-administered versus provider-administered methods.
DATA COLLECTION AND ANALYSIS
Two reviewers independently extracted the data, and we performed a meta-analysis where appropriate using Review Manager 5. Our primary outcome was successful abortion (effectiveness), defined as complete uterine evacuation without the need for surgical intervention. Ongoing pregnancy (the presence of an intact gestational sac) was our secondary outcome measuring success or effectiveness. We assessed statistical heterogeneity with Chi tests and I statistics using a cut-off point of P < 0.10 to indicate statistical heterogeneity. Quality assessment of the data used the GRADE approach. We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We identified 18 studies (two RCTs and 16 non-randomized studies (NRSs)) comprising 11,043 women undergoing early medical abortion (≤ 9 weeks gestation) in 10 countries. Sixteen studies took place in low-to-middle income resource settings and two studies were in high-resource settings. One NRS study received analgesics from a pharmaceutical company. Five NRSs and one RCT did not report on funding; nine NRSs received all or partial funding from an anonymous donor. Five NRSs and one RCT received funding from government agencies, private foundations, or non-profit bodies. The intervention in the evidence is predominantly from women taking mifepristone in the presence of a healthcare provider, and subsequently taking misoprostol without healthcare provider supervision (e.g. at home). There is no evidence of a difference in rates of successful abortions between self-administered and provider-administered groups: for two RCTs, risk ratio (RR) 0.99, 95% confidence interval (CI) 0.97 to 1.01; 919 participants; moderate certainty of evidence. There is very low certainty of evidence from 16 NRSs: RR 0.99, 95% CI 0.97 to 1.01; 10,124 participants. For the outcome of ongoing pregnancy there may be little or no difference between the two groups: for one RCT: RR 1.69, 95% CI 0.41 to 7.02; 735 participants; low certainty of evidence; and very low certainty evidence for 11 NRSs: RR 1.28, 95% CI 0.65 to 2.49; 6691 participants. We are uncertain whether there are any differences in complications requiring surgical intervention, since we found no RCTs and evidence from three NRSs was of very low certainty: for three NRSs: RR 2.14, 95% CI 0.80 to 5.71; 2452 participants.
AUTHORS' CONCLUSIONS
This review shows that self-administering the second stage of early medical abortion procedures is as effective as provider-administered procedures for the outcome of abortion success. There may be no difference for the outcome of ongoing pregnancy, although the evidence for this is uncertain for this outcome. There is very low-certainty evidence for the risk of complications requiring surgical intervention. Data are limited by the scarcity of high-quality research study designs and the presence of risks of bias. This review provides insufficient evidence to determine the safety of self-administration when compared with administering medication in the presence of healthcare provider supervision. Future research should investigate the effectiveness and safety of self-administered medical abortion in the absence of healthcare provider supervision through the entirety of the medical abortion protocol (e.g. during administration of mifepristone or as part of a misoprostol-only regimen) and at later gestational ages (i.e. more than nine weeks). In the absence of any supervision from medical personnel, research is needed to understand how best to inform and support women who choose to self-administer, including when to seek clinical care.
Topics: Abortifacient Agents; Abortion, Induced; Female; Humans; Mifepristone; Misoprostol; Patient Safety; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic
PubMed: 32150279
DOI: 10.1002/14651858.CD013181.pub2 -
The Cochrane Database of Systematic... Feb 2020Induction of labour involves stimulating uterine contractions artificially to promote the onset of labour. There are several pharmacological, surgical and mechanical... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Induction of labour involves stimulating uterine contractions artificially to promote the onset of labour. There are several pharmacological, surgical and mechanical methods used to induce labour. Membrane sweeping is a mechanical technique whereby a clinician inserts one or two fingers into the cervix and using a continuous circular sweeping motion detaches the inferior pole of the membranes from the lower uterine segment. This produces hormones that encourage effacement and dilatation potentially promoting labour. This review is an update to a review first published in 2005.
OBJECTIVES
To assess the effects and safety of membrane sweeping for induction of labour in women at or near term (≥ 36 weeks' gestation).
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (25 February 2019), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 February 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials comparing membrane sweeping used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed on a predefined list of labour induction methods. Cluster-randomised trials were eligible, but none were identified.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion, risk of bias and extracted data. Data were checked for accuracy. Disagreements were resolved by discussion, or by including a third review author. The certainty of the evidence was assessed using the GRADE approach.
MAIN RESULTS
We included 44 studies (20 new to this update), reporting data for 6940 women and their infants. We used random-effects throughout. Overall, the risk of bias was assessed as low or unclear risk in most domains across studies. Evidence certainty, assessed using GRADE, was found to be generally low, mainly due to study design, inconsistency and imprecision. Six studies (n = 1284) compared membrane sweeping with more than one intervention and were thus included in more than one comparison. No trials reported on the outcomes uterine hyperstimulation with/without fetal heart rate (FHR) change, uterine rupture or neonatal encephalopathy. Forty studies (6548 participants) compared membrane sweeping with no treatment/sham Women randomised to membrane sweeping may be more likely to experience: · spontaneous onset of labour (average risk ratio (aRR) 1.21, 95% confidence interval (CI) 1.08 to 1.34, 17 studies, 3170 participants, low-certainty evidence). but less likely to experience: · induction (aRR 0.73, 95% CI 0.56 to 0.94, 16 studies, 3224 participants, low-certainty evidence); There may be little to no difference between groups for: · caesareans (aRR 0.94, 95% CI 0.85 to 1.04, 32 studies, 5499 participants, moderate-certainty evidence); · spontaneous vaginal birth (aRR 1.03, 95% CI 0.99 to 1.07, 26 studies, 4538 participants, moderate-certainty evidence); · maternal death or serious morbidity (aRR 0.83, 95% CI 0.57 to 1.20, 17 studies, 2749 participants, low-certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.83, 95% CI 0.59 to 1.17, 18 studies, 3696 participants, low-certainty evidence). Four studies reported data for 480 women comparing membrane sweeping with vaginal/intracervical prostaglandins There may be little to no difference between groups for the outcomes: · spontaneous onset of labour (aRR, 1.24, 95% CI 0.98 to 1.57, 3 studies, 339 participants, low-certainty evidence); · induction (aRR 0.90, 95% CI 0.56 to 1.45, 2 studies, 157 participants, low-certainty evidence); · caesarean (aRR 0.69, 95% CI 0.44 to 1.09, 3 studies, 339 participants, low-certainty evidence); · spontaneous vaginal birth (aRR 1.12, 95% CI 0.95 to 1.32, 2 studies, 252 participants, low-certainty evidence); · maternal death or serious morbidity (aRR 0.93, 95% CI 0.27 to 3.21, 1 study, 87 participants, low-certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.40, 95% CI 0.12 to 1.33, 2 studies, 269 participants, low-certainty evidence). One study, reported data for 104 women, comparing membrane sweeping with intravenous oxytocin +/- amniotomy There may be little to no difference between groups for: · spontaneous onset of labour (aRR 1.32, 95% CI 88 to 1.96, 1 study, 69 participants, low-certainty evidence); · induction (aRR 0.51, 95% CI 0.05 to 5.42, 1 study, 69 participants, low-certainty evidence); · caesarean (aRR 0.69, 95% CI 0.12 to 3.85, 1 study, 69 participants, low-certainty evidence); · maternal death or serious morbidity was reported on, but there were no events. Two studies providing data for 160 women compared membrane sweeping with vaginal/oral misoprostol There may be little to no difference between groups for: · caesareans (RR 0.82, 95% CI 0.31 to 2.17, 1 study, 96 participants, low-certainty evidence). One study providing data for 355 women which compared once weekly membrane sweep with twice-weekly membrane sweep and a sham procedure There may be little to no difference between groups for: · induction (RR 1.19, 95% CI 0.76 to 1.85, 1 study, 234 participants, low-certainty); · caesareans (RR 0.93, 95% CI 0.60 to 1.46, 1 study, 234 participants, low-certainty evidence); · spontaneous vaginal birth (RR 1.00, 95% CI 0.86 to 1.17, 1 study, 234 participants, moderate-certainty evidence); · maternal death or serious maternal morbidity (RR 0.78, 95% CI 0.30 to 2.02, 1 study, 234 participants, low-certainty evidence); · neonatal death or serious neonatal perinatal morbidity (RR 2.00, 95% CI 0.18 to 21.76, 1 study, 234 participants, low-certainty evidence); We found no studies that compared membrane sweeping with amniotomy only or mechanical methods. Three studies, providing data for 675 women, reported that women indicated favourably on their experience of membrane sweeping with one study reporting that 88% (n = 312) of women questioned in the postnatal period would choose membrane sweeping in the next pregnancy. Two studies reporting data for 290 women reported that membrane sweeping is more cost-effective than using prostaglandins, although more research should be undertaken in this area.
AUTHORS' CONCLUSIONS
Membrane sweeping may be effective in achieving a spontaneous onset of labour, but the evidence for this was of low certainty. When compared to expectant management, it potentially reduces the incidence of formal induction of labour. Questions remain as to whether there is an optimal number of membrane sweeps and timings and gestation of these to facilitate induction of labour.
Topics: Amnion; Cervical Ripening; Female; Humans; Labor, Induced; Mechanical Phenomena; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic; Risk Factors; Term Birth
PubMed: 32103497
DOI: 10.1002/14651858.CD000451.pub3 -
BMJ Sexual & Reproductive Health Oct 2020Medical abortion with mifepristone and misoprostol usually involves an interval of 36-48 hours between administering these drugs; however, it is possible that the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Medical abortion with mifepristone and misoprostol usually involves an interval of 36-48 hours between administering these drugs; however, it is possible that the clinical efficacy at early gestations may be maintained when the drugs are taken simultaneously. The objective of this systematic review was to determine the safety and effectiveness of simultaneous compared with interval administration of mifepristone and misoprostol for abortion up to 10 weeks' gestation.
METHODS
We searched Embase Classic, Embase; Ovid MEDLINE(R) including Daily, and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations; and Cochrane Library on 11 December 2019. We included randomised controlled trials (RCTs), published in English from 1985, comparing simultaneous to interval administration of mifepristone and misoprostol for early abortion. Risk of bias was assessed using the Cochrane Collaboration checklist for RCTs. Meta-analysis of risk ratios (RRs) using the Mantel-Haenszel method were performed. The quality of the evidence was assessed using GRADE.
RESULTS
Meta-analyses of three RCTs (n=1280) showed no differences in 'ongoing pregnancy' (RR 1.78, 95% CI 0.38 to 8.36), 'haemorrhage requiring transfusion or ≥500 mL blood loss' (RR 0.11, 95% CI 0.01 to 2.03) and 'incomplete abortion with the need for surgical intervention' (RR 1.30, 95% CI 0.76 to 2.25) between the interventions. Individual study results showed no difference in patient satisfaction, or 'need for repeat misoprostol', although 'time to onset of bleeding or cramping' was longer after simultaneous than interval administration. The quality of evidence was very low to moderate.
CONCLUSION
The published data support the use of simultaneous mifepristone and misoprostol for medical abortion up to 9 weeks in women who prefer this method of administration.
Topics: Abortifacient Agents, Steroidal; Abortion, Induced; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Pregnancy
PubMed: 32079651
DOI: 10.1136/bmjsrh-2019-200448 -
BMC Pregnancy and Childbirth Dec 2019To systematically review the literature on clinical interventions that influence vaginal birth after cesarean (VBAC) rates. (Meta-Analysis)
Meta-Analysis
BACKGROUND
To systematically review the literature on clinical interventions that influence vaginal birth after cesarean (VBAC) rates.
METHODS
We searched Ovid Medline, Ovid Embase, Wiley Cochrane Library, CINAHL via EBSCOhost; and Ovid PsycINFO. Additional studies were identified by searching for clinical trial records, conference proceedings and dissertations. Limits were applied for language (English and French) and year of publication (1985 to present). Two reviewers independently screened comparative studies (randomized or non-randomized controlled trials, and observational designs) according to a priori eligibility criteria: women with prior cesarean sections; any clinical intervention or exposure intended to increase the VBAC rate; any comparator; and, outcomes reporting VBAC, uterine rupture and uterine dehiscence rates. One reviewer extracted data and a second reviewer verified for accuracy. Meta-analysis was conducted using Mantel-Haenszel (random effects model) relative risks (VBAC rate) and risk differences (uterine rupture and dehiscence). Two reviewers independently conducted methodological quality assessments using the Mixed Methods Appraisal Tool (MMAT).
RESULTS
Twenty-nine studies (six trials and 23 cohorts) examined different clinical interventions affecting rates of vaginal deliveries among women with a prior cesarean delivery (CD). Methodological quality was good overall for the trials; however, concerns among the cohort studies regarding selection bias, comparability of groups and outcome measurement resulted in higher risk of bias. Interventions for labor induction, with or without cervical ripening, included pharmacologic (oxytocin, prostaglandins, misoprostol, mifepristone, epidural analgesia), non-pharmacologic (membrane sweep, amniotomy, balloon devices), and combined (pharmacologic and non-pharmacologic). Single studies with small sample sizes and event rates contributed to most comparisons, with no clear differences between groups on rates of VBAC, uterine rupture and uterine dehiscence.
CONCLUSIONS
This systematic review evaluated clinical interventions directed at increasing the rate of vaginal delivery among women with a prior CD and found low to very low certainty in the body of evidence for cervical ripening and/or labor induction techniques. There is insufficient high-quality evidence to inform optimal clinical interventions among women attempting a trial of labor after a prior CD.
Topics: Cervical Ripening; Cesarean Section; Clinical Trials as Topic; Cohort Studies; Delivery, Obstetric; Female; Humans; Labor, Induced; Pregnancy; Vaginal Birth after Cesarean
PubMed: 31888540
DOI: 10.1186/s12884-019-2689-5