The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomised trial.

OBJECTIVE: To assess the effectiveness of introducing condom-catheter uterine balloon tamponade (UBT) for postpartum haemorrhage (PPH) management in low- and middle-income settings. DESIGN: Stepped wedge, cluster-randomised trial. SETTING: Eighteen secondary-level hospitals in Uganda, Egypt and Senegal. POPULATION: Women with vaginal delivery from October 2016 to March 2018. METHODS: Use of condom-catheter UBT for PPH management was introduced using a half-day training and provision of pre-packaged UBT kits. Hospitals were randomised to when UBT was introduced. The incident rate (IR) of study outcomes was compared in the control (i.e. before UBT) and intervention (i.e. after UBT) periods. Mixed effects regression models accounted for clustering (random effect) and time period (fixed effect). MAIN OUTCOME MEASURES: Combined IR of PPH-related invasive surgery and/or maternal death. RESULTS: There were 28 183 and 31 928 deliveries in the control and intervention periods, respectively. UBT was used for 9/1357 and 55/1037 women diagnosed with PPH in control and intervention periods, respectively. PPH-related surgery or maternal death occurred in 19 women in the control period (IR = 6.7/10 000 deliveries) and 37 in the intervention period (IR = 11.6/10 000 deliveries). The adjusted IR ratio was 4.08 (95% confidence interval 1.07-15.58). Secondary outcomes, including rates of transfer and blood transfusion, were similar in the trial periods. CONCLUSIONS: Introduction of condom-catheter UBT in these settings did not improve maternal outcomes and was associated with an increase in the combined incidence of PPH-related surgery and maternal death. The lack of demonstrated benefit of UBT introduction with respect to severe outcomes warrants reflection on its role. TWEETABLE ABSTRACT: Stepped wedge trial shows UBT introduction does not reduce the combined incidence of PPH-related surgery or death.

Foley catheter vs. oral misoprostol to induce labour among hypertensive women in India: a cost-consequence analysis alongside a clinical trial.

OBJECTIVE: To determine the effectiveness and economic impact of two methods for induction of labour in hypertensive women, in low-resource settings. DESIGN: Cost-consequence analysis of a previously reported multicentre, parallel, open-label randomised trial. SETTING & POPULATION: A total of 602 women with a live fetus, aged ≥18 years requiring delivery for pre-eclampsia or hypertension, in two public hospitals in Nagpur, India. METHODS: We performed a formal economic evaluation alongside the INFORM clinical trial. Women were randomised to receive transcervical Foley catheterisation or oral misoprostol 25 mcg. Healthcare expenditure was calculated using a provider-side microcosting approach. MAIN OUTCOME MEASURES: Rates of vaginal this delivery within 24 hours of induction, healthcare expenditure per completed treatment episode. RESULTS: Induction with oral misoprostol resulted in a (mean difference) $20.6USD reduction in healthcare expenditure [95% CI (-) $123.59 (-) $72.49], and improved achievement of vaginal delivery within 24 hours of induction, mean difference 10% [95% CI (-2 to 17.9%), P = 0.016]. Oxytocin administration time was reduced by 135.3 minutes [95% CI (84.4-186.2 minutes), P < 0.01] and caesarean sections by 9.1% [95% CI (1.1-17%), P = 0.025] for those receiving oral misoprostol. Following probabilistic sensitivity analysis, oral misoprostol was cost-saving in 63% of 5,000 bootstrap replications and achieved superior rates of vaginal delivery, delivery within 24 hours of induction and vaginal delivery within 24 hours of induction in 98.7%, 90.7%, and 99.4% of bootstrap simulations. Based on univariate threshold analysis, the unit price of oral misoprostol 25 mcg could feasibly increase 31-fold from $0.24 to $7.50 per 25 mcg tablet and remain cost-saving. CONCLUSION: Compared to Foley catheterisation for the induction of high-risk hypertensive women, oral misoprostol improves rates of vaginal delivery within 24 hours of induction and may also reduce costs. Additional research performed in other low-resource settings is required to determine their relative cost-effectiveness. TWEETABLE ABSTRACT: Oral misoprostol less costly and more effective than Foley catheter for labour induction in hypertension.

Postpartum hemorrhage: new insights for definition and diagnosis.

The current definition of is inadequate for early recognition of this important cause of maternal death that is responsible for >80,000 deaths worldwide in 2015. A stronger definition of postpartum hemorrhage should include both blood loss and clinical signs of cardiovascular changes after delivery, which would help providers to identify postpartum hemorrhage more promptly and accurately. Along with the amount of blood loss, clinical signs, and specifically the shock index (heart rate divided by systolic blood pressure) appear to aid in more accurate diagnosis of postpartum hemorrhage.

Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster-randomised non-inferiority community trial.

OBJECTIVE: To assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis. DESIGN: A cluster-randomised non-inferiority community trial. SETTING: Health sub-centres and home deliveries in the Bijapur district of Karnataka, India. POPULATION: Women with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study. METHODS: Auxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour. MAIN OUTCOME MEASURES: Postpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention. RESULTS: Misoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013). CONCLUSION: Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level. TWEETABLE ABSTRACT: Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.

Postpartum haemorrhage management, risks, and maternal outcomes: findings from the World Health Organization Multicountry Survey on Maternal and Newborn Health.

OBJECTIVE: To explore the clinical practices, risks, and maternal outcomes associated with postpartum haemorrhage (PPH). DESIGN: Secondary analysis of cross-sectional data. SETTING: A total of 352 health facilities in 28 countries. SAMPLE: A total of 274 985 women giving birth between 1 May 2010 and 31 December 2011. METHODS: We used multivariate logistic regression to examine factors associated with PPH among all births, and the Pearson chi-square test to examine correlates of severe maternal outcomes (SMOs) among women with PPH. All analyses adjust for facility- and country-level clustering. MAIN OUTCOME MEASURES: PPH, SMOs, and clinical practices for the management of PPH. RESULTS: Of all the women included in the analysis, 95.3% received uterotonic prophylaxis and the reported rate of PPH was 1.2%. Factors significantly associated with PPH diagnosis included age, parity, gestational age, induction of labour, caesarean section, and geographic region. Among those with PPH, 92.7% received uterotonics for treatment, and 17.2% had an SMO. There were significant differences in the incidence of SMOs by age, parity, gestational age, anaemia, education, receipt of uterotonics for prophylaxis or treatment, referral from another facility, and Human Development Index (HDI) group. The rates of death were highest in countries with low or medium HDIs. CONCLUSIONS: Among women with PPH, disparities in the incidence of severe maternal outcomes persist, even among facilities that report capacity to provide all essential emergency obstetric interventions. This highlights the need for better information about the role of institutional capacity, including quality of care, in PPH-related morbidity and mortality.

Overview of abortion cases with severe maternal outcomes in the WHO Multicountry Survey on Maternal and Newborn Health: a descriptive analysis.

OBJECTIVE: To summarise individual and institutional characteristics of abortion-related severe maternal outcomes reported at health facilities. DESIGN: Secondary analysis of data from the WHO Multicountry Survey on Maternal and Newborn Health. SETTING: 85 health facilities in 23 countries. SAMPLE: 322 women with abortion-related severe maternal outcomes. METHODS: Frequency distributions and comparisons of differences in characteristics between cases of maternal near miss and death using Fisher's exact tests of association. MAIN OUTCOME MEASURES: Individual and institutional characteristics and frequencies of potentially life-threatening conditions, and interventions provided to women with severe maternal outcomes, maternal near miss, and maternal death. RESULTS: Most women with abortion-related severe maternal outcomes (SMOs) were 20-34 years old (65.2%), married or cohabitating (92.3%), parous (84.2%), and presented with abortions resulting from pregnancies at less than 14 weeks of gestation (67.1%). The women who died were younger, more frequently without a partner, and had abortions at ≥14 weeks of gestation, compared with women with maternal near miss (MNM). Curettage was the most common mode of uterine evacuation. The provision of blood products and therapeutic antibiotics were the most common other interventions recorded for all women with abortion-related SMOs; those who died more frequently had antibiotics, laparotomy, and hysterectomy, compared with women with MNM. Although haemorrhage was the most common cause of abortion-related SMO, infection (alone and in combination with haemorrhage) was the most common cause of death. CONCLUSION: This analysis affirms a number of previously observed characteristics of women with abortion-related severe morbidity and mortality, despite the fact that facility-based data on abortion-related SMO suffers a number of limitations.

Magnesium sulphate for prevention of eclampsia: are intramuscular and intravenous regimens equivalent? A population pharmacokinetic study.

OBJECTIVE: To compare magnesium sulphate concentrations achieved by intramuscular and intravenous regimens used for the prevention of eclampsia. SETTING: Low-resource obstetric hospitals in Nagpur and Vellore, India. POPULATION: Pregnant women at risk for eclampsia due to hypertensive disease. METHODS: A pharmacokinetic study was performed as part of a randomised trial that enrolled 300 women comparing intramuscular and intravenous maintenance regimens of magnesium dosing. Data from 258 enrolled women were analysed in the pharmacokinetic study. A single sample was drawn per woman with the expectation of using samples in a pooled data analysis. MAIN OUTCOME MEASURES: Pharmacokinetic parameters of magnesium distribution and clearance. RESULTS: Magnesium clearance was estimated to be 48.1 dl/hour, volume of distribution to be 156 dl and intramuscular bioavailability to be 86.2%. The intramuscular regimen produced higher initial serum concentrations, consistent with a substantially larger loading dose. At steady state, magnesium concentrations in the intramuscular and intravenous groups were comparable. With either regimen, a substantial number of women would be expected to have serum concentrations lower than those generally held to be therapeutic. CONCLUSIONS: Clinical implications were that a larger loading dose for the intravenous regimen should be considered; where feasible, individualised dosing of magnesium sulphate would reduce the variability in serum concentrations and might result in more women with clinically effective magnesium concentrations; and lower dose magnesium sulphate regimens should be considered with caution.

OS034. Magnesium sulfate for prevention of eclampsia: Are intramuscularand intravenous regimens equivalent?

INTRODUCTION: Magnesium sulfate is the agent of choice for the treatment and prevention of eclampsia. Optimal loading and maintenance dosing has not been determined. OBJECTIVES: To compare the pharmacokinetic parameters if IM vs. IV magnesium sulfate. METHODS: A pharmacokinetic study was performed as part of a randomized trial that enrolled 300 women comparing IM and IV regimens of magnesium dosing in two low resource sites in India. Data from 258 enrolled women were analyzed in the pharmacokinetic study. Due to infrastructure available at the sites, a single sample was drawn per subject with the expectation of utilizing samples in a pooled data analysis. RESULTS: Magnesium clearance was estimated via pharmacokinetic modeling to be 48.1dL/h, volume of distribution 156dL and IM bioavailability 86.2%. The IM regimen produced higher initial serum concentrations, consistent with a substantially larger loading dose. At steady state, Mg concentrations in the IM and IV Groups were comparable. With either regimen, a substantial number of subjects would be expected to have serum concentrations lower than those generally expected to be therapeutic. CONCLUSION: A larger loading dose for the IV regimen should be considered. Where feasible, individualized higher doses of magnesium sulfate would yield a greater number of treated women with clinically effective magnesium concentrations.

Community Kangaroo Mother Care: implementation and potential for neonatal survival and health in very low-income settings.

OBJECTIVE: Immediate Kangaroo Mother Care (KMC), an intervention following childbirth whereby the newborn is placed skin-to-skin (STS) on mother's chest to promote thermal regulation, breastfeeding and maternal-newborn bonding, is being taught in very low-income countries to improve newborn health and survival. Existing data are reviewed to document the association between community-based KMC (CKMC) implementation and its potential benefits. STUDY DESIGN: New analyses of the sole randomized controlled study of CKMC in Bangladesh and others' experiences with immediate KMC are presented. RESULT: Newborns held STS less than 7 h per day in the first 2 days of life do not experience substantially better health or survival than babies without being held STS. CONCLUSION: Most women who were taught CKMC hold their newborns STS, but do so in a token manner unlikely to improve health or survival. Serious challenges exist to provide effective training and postpartum support to achieve adequate STS practices. These challenges must be overcome before scaling up.

Alternatives to routine ultrasound for eligibility assessment prior to early termination of pregnancy with mifepristone-misoprostol.

OBJECTIVE: To test the feasibility and efficacy of an approach that foregoes the routine use of ultrasound for the determination of eligibility for medical termination of pregnancy. DESIGN: Prospective trial. SETTING: Ten termination of pregnancy clinics in the USA. POPULATION: A total of 4484 women seeking termination of pregnancy with mifepristone-misoprostol. METHODS: Women provided estimates of the date of their last menstrual period and underwent pelvic bimanual and ultrasound examinations. We compared estimates of gestational age using these three methods. MAIN OUTCOME MEASURE: Proportion of women of ≤9 weeks' gestation by woman or provider estimate, but >9 weeks' gestation by ultrasound. RESULTS: The reliance on women's report of their last menstrual period together with physical examination to determine their eligibility for termination of pregnancy with mifepristone-misoprostol would result in few women (63/4008 or 1.6%) accepted for treatment outside the current limits of standard mifepristone-misoprostol regimens used for early termination of pregnancy (i.e. ≤63 days' gestation on ultrasound). CONCLUSIONS: Last menstrual period and physical examination alone, without the routine use of ultrasound, are highly effective for the determination of women's eligibility for early termination of pregnancy with mifepristone-misoprostol.

What measured blood loss tells us about postpartum bleeding: a systematic review.

BACKGROUND: Meta-analyses of postpartum blood loss and the effect of uterotonics are biased by visually estimated blood loss. OBJECTIVES: To conduct a systematic review of measured postpartum blood loss with and without prophylactic uterotonics for prevention of postpartum haemorrhage (PPH). SEARCH STRATEGY: We searched Medline and PubMed terms (labour stage, third) AND (ergonovine, ergonovine tartrate, methylergonovine, oxytocin, oxytocics or misoprostol) AND (postpartum haemorrhage or haemorrhage) and Cochrane reviews without any language restriction. SELECTION CRITERIA: Refereed publications in the period 1988-2007 reporting mean postpartum blood loss, PPH (> or =500 ml) or severe PPH (> or =1000 ml) following vaginal births. DATA COLLECTION AND ANALYSIS: Raw data were abstracted into Excel by one author and then reviewed by a co-author. Data were transferred to SPSS 17.0, and copied into RevMan 5.0 to perform random effects meta-analysis. MAIN RESULTS: The distribution of average blood loss (29 studies) is similar with any prophylactic uterotonic, and is lower than without prophylaxis. Compared with no uterotonic, oxytocin and misoprostol have lower PPH (OR 0.43, 95% CI 0.23-0.81; OR 0.73, 95% CI 0.50-1.08, respectively) and severe PPH rates (OR 0.61, 95% CI 0.29-1.29; OR 0.74, 95% CI 0.52-1.04, respectively). Oxytocin has lower PPH (OR 0.65, 95% CI 0.60-0.70) and severe PPH (OR 0.71, 95% CI 0.56-0.91) rates than misoprostol, but not in developing countries. CONCLUSION: Oxytocin is superior to misoprostol in hospitals. Misoprostol substantially lowers PPH and severe PPH. A sound assessment of the relative merits of the two drugs is needed in rural areas of developing countries, where most PPH deaths occur.

High fever following postpartum administration of sublingual misoprostol.

OBJECTIVE: To explore what triggers an elevated body temperature of > or =40.0 degrees C in some women given misoprostol, a prostaglandin E1 analogue, for postpartum haemorrhage (PPH). DESIGN: Post hoc analysis. SETTING: One tertiary-level hospital in Quito, Ecuador. POPULATION: A cohort of 58 women with a fever of above 40 degrees C following treatment with sublingual misoprostol (800 micrograms) for PPH. METHODS: Side effects were documented for 163 Ecuadorian women given sublingual misoprostol to treat their PPH. Women's body temperatures were measured, and if they had a fever of > or =40.0 degrees C, measurements were taken hourly until the fever subsided. Temperature trends were analysed, and the possible physiological mechanisms by which postpartum misoprostol produces a high fever were explored. MAIN OUTCOME MEASURES: The onset, duration, peak temperatures, and treatments administered for cases with a high fever. RESULTS: Fifty-eight of 163 women (35.6%) treated with misoprostol experienced a fever of > or =40.0 degrees C. High fevers followed a predictable pattern, often preceded by moderate/severe shivering within 20 minutes of treatment. Body temperatures peaked 1-2 hours post-treatment, and gradually declined over 3 hours. Fevers were transient and did not lead to any hospitalisation. Baseline characteristics were comparable among women who did and did not develop a high fever, except for known previous PPH and time to placental expulsion. CONCLUSIONS: An unexpectedly high rate of elevated body temperature of > or =40.0 degrees C was documented in Ecuador following sublingually administered misoprostol. It is unclear why temperatures > or =40.0 degrees C occurred with a greater frequency in Ecuador than in other study populations using similar treatment regimens for PPH. Pharmacogenetic studies may shed further light on variations in individuals' responses to misoprostol.

Treatment of postpartum hemorrhage with misoprostol.

A literature review was conducted to determine whether misoprostol is an effective treatment for postpartum hemorrhage (PPH) and in what dose. All English language articles published before March 2007 reporting on misoprostol for treatment of PPH were reviewed. Unpublished data previously presented at international scientific meetings were also included in the review. Little evidence exists in support of misoprostol for treatment of postpartum hemorrhage (PPH). Nonetheless, PPH remains a major killer of women worldwide, and new treatment options are widely sought. For this reason, we recommend a single dose of misoprostol 600 microg oral or sublingual for PPH treatment in instances when other treatments have either failed to work or are not available.

Misoprostol to treat missed abortion in the first trimester.

Missed abortion in the first trimester is characterized by the arrest of embryonic or fetal development. The cervix is closed and there is no or only slight bleeding. Ultrasound examination shows an empty gestational sac or an embryo/fetus without cardiac activity. Based on a review of the published literature a single dose of 800 microg vaginal misoprostol may be offered as an effective, safe, and acceptable alternative to the traditional surgical treatment for this indication. Alternatively, 600 microg misoprostol can be administered sublingually. After administration of misoprostol, hospitalization is not necessary and the time to expulsion varies considerably. Bleeding may last for more than 14 days with additional days of light bleeding or spotting. The woman should be advised to contact a provider in case of heavy bleeding or signs of infection. A follow-up is recommended after 1 to 2 weeks.

Treatment of incomplete abortion and miscarriage with misoprostol.

A literature review was conducted to determine whether misoprostol is an effective treatment for incomplete abortion and, if so, to recommend an appropriate regimen. All English language articles published before October 2007 using misoprostol in at least one of the study arms were reviewed to determine the efficacy of misoprostol when used to treat incomplete abortion in the first trimester. All available unpublished data previously presented at international scientific meetings were also reviewed. Sufficient evidence was found in support of misoprostol as a safe and effective means of non-surgical uterine evacuation. A single dose of misoprostol 600 microg oral is recommended for treatment of incomplete abortion in women presenting with a uterine size equivalent to 12 weeks gestation.

Prevention of postpartum hemorrhage with misoprostol.

As a stable, orally active and cheap uterotonic, misoprostol would appear ideally suited to the prevention of postpartum hemorrhage (PPH) in the developing world. Following numerous clinical trials, it appears that misoprostol prophylaxis using an oral or sublingual dose of 600 microg is more effective than placebo at preventing PPH in community births (relative risk 0.59, 95% confidence intervals 0.41-0.84), but not in hospital settings (RR 1.23, 95% CI 0.86-1.74). It is, however, not as effective as injectable oxytocin (RR 1.34, 95% CI 1.16 to 1.55). Misoprostol is therefore indicated for prevention of PPH in settings where injectable conventional uterotonics are not available. In the event of continued hemorrhage, a minimum of 2 h should lapse after the original dose before a second dose is given. If the initial dose was associated with pyrexia or marked shivering, at least 6 h should lapse before the second dose is given.

Is misoprostol a safe, effective and acceptable alternative to manual vacuum aspiration for postabortion care? Results from a randomised trial in Burkina Faso, West Africa.

OBJECTIVES: Previous research has demonstrated the effectiveness of misoprostol for treatment of incomplete abortion; however, few studies have systematically compared misoprostol's effectiveness with that of standard surgical care. This study documents the effectiveness of a single 600 micrograms dose of oral misoprostol versus manual vacuum aspiration (MVA) for treatment of incomplete abortion in a developing country setting. DESIGN: Open-label randomised controlled trial. SETTING: Two university teaching hospitals in Burkina Faso, West Africa. POPULATION: Women of reproductive age presenting with incomplete abortion. METHODS: From April 2004 through October 2004, 447 consenting women with incomplete abortion were randomised to either a single dose of 600 micrograms oral misoprostol or MVA for treatment of their condition. MAIN OUTCOME MEASURE: Completed abortion following initial treatment. RESULTS: Regardless of treatment assigned, nearly all participants had a complete uterine evacuation (misoprostol = 94.5%, MVA = 99.1%; relative risk [RR] = 0.95 [95% CI 0.92-0.99]). Acceptability and satisfaction ratings were similar and high for both misoprostol and MVA, with three out of four women indicating that the treatment's adverse effects were tolerable (misoprostol = 72.9%, MVA = 75.8%; RR = 0.96 [95% CI 0.86-1.07]). The majority of women were 'satisfied' or 'very satisfied' with the method they received (misoprostol = 96.8%, MVA = 97.7%; RR = 0.99 [95% CI 0.96-1.02]), expressed a desire to choose that method again (misoprostol = 94.5%, MVA = 86.6%; RR = 1.09 [95% CI 1.03-1.16]) and to recommend it to a friend (misoprostol = 94.5%, MVA = 85.2%; RR = 1.11 [95% CI 1.04-1.18]). CONCLUSION: Six hundred micrograms of oral misoprostol is as safe and acceptable as MVA for the treatment of incomplete abortion. Operations research is needed to ascertain the role of misoprostol within postabortion care programmes worldwide.

Misoprostol for treatment of incomplete abortion at the regional hospital level: results from Tanzania.

OBJECTIVE: To investigate the safety, efficacy, and acceptability of misoprostol versus manual vacuum aspiration (MVA) for treatment of incomplete abortion. DESIGN: A prospective open-label randomised trial. SETTING: Kagera Regional Hospital, Bukoba, Tanzania. SAMPLE: Three hundred women with a clinical diagnosis of incomplete abortion and a uterine size <12 weeks. METHODS: A total of 150 women were randomised to either a single dose of 600 micrograms of oral misoprostol or MVA. If abortion was clinically complete at 7-day follow up, the woman was released from the study. If it was still incomplete, the woman was offered the choice of an additional 1-week follow up or immediate MVA. Cases still incomplete after a further week were offered MVA. MAIN OUTCOME MEASURES: Incidence of successful abortion (success defined as no secondary surgical intervention provided), incidence of adverse effects, patient satisfaction. RESULTS: Success was very high in both arms (misoprostol: 99%; MVA: 100%; difference not significant). Most adverse effects were higher in the misoprostol arm, although the mean pain score was higher in the MVA arm (3.0 versus 3.5; P < 0.001). More women were very satisfied with misoprostol (75%) than with MVA (55%, P = 0.001), and a higher proportion of women in the misoprostol arm said that they would recommend the treatment to a friend (95% versus 75%, P < 0.001). CONCLUSION: Misoprostol is as effective as MVA at treating incomplete abortion at uterine size of <12 weeks. The acceptability of misoprostol appears higher. Given the many practical advantages of misoprostol over MVA in low-resource settings, misoprostol should be more widely available for treatment of incomplete abortion in the developing world.

Comparison of misoprostol and manual vacuum aspiration for the treatment of incomplete abortion.

OBJECTIVE: To compare the safety, efficacy, and acceptability of misoprostol versus manual vacuum aspiration (MVA) for treatment of incomplete abortion in Maputo, Mozambique. METHODS: A total of 270 women with clinically diagnosed incomplete abortions of up to 12 weeks of gestation were randomized to either 600 mug oral misoprostol or MVA. Women were followed-up seven days later to evaluate whether the abortion was complete. RESULTS: Success was high for both MVA and misoprostol groups (100% vs 91%, P=0.002). Women in the MVA arm reported fewer side effects but higher pain scores. Women who received misoprostol were significantly more likely to be "very satisfied" with the treatment and willing to choose the method again. CONCLUSION: Although oral misoprostol was less effective than MVA in this study, it was more acceptable to women. Misoprostol is well-suited for use in low-resource settings, and should be promoted as an option for the treatment of incomplete abortion.

Does methotrexate confer a significant advantage over misoprostol alone for early medical abortion? A retrospective analysis of 8678 abortions.

OBJECTIVE: The objective of this study was to compare efficacy for four medical abortion regimens used in one clinic setting: (1) misoprostol alone, (2) oral methotrexate + buccal misoprostol, (3) oral methotrexate + vaginal misoprostol, and (4) intramuscular methotrexate + vaginal misoprostol. DESIGN: Retrospective analysis of data from clinical records. SETTING: An anonymous women's health centre in Latin America, providing medical abortion services since 2001 in a highly restrictive setting. POPULATION: A total of 8678 women with gestations <56 days, who sought a medical abortion between April 2002 and December 2004. METHODS: Chi-square test was performed to compare patient characteristics by abortion outcome (success/failure). The impact of selected variables on method success was explored through logistic regression. A second regression analysis was conducted with a subsample (n = 4022), for which data on parity and previous abortion(s) were available. MAIN OUTCOME MEASURE: Abortion outcome (success/failure) at 2-week follow up. RESULTS: Success rates for the three methotrexate regimens ranged from 81.7 to 83.5% and did not differ significantly; misoprostol-alone regimen had a success rate of 76.8%. Efficacy was significantly higher for the three combined methotrexate regimens compared with misoprostol alone and remained so in the multivariate model (OR = 1.35). In the final regression, lower gestational age, being nulliparous, and having no previous abortions were positively correlated with method success. CONCLUSIONS: In this real-use setting, methotrexate appears to confer a significant advantage over misoprostol alone for early medical abortion. This finding is important for settings where mifepristone remains unavailable. Additional factors such as gestational age limits and patient preference should be considered in regimen selection.