Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. In Afghanistan, where most births take place at home without the assistance of a skilled birth attendant, there is a need for options to manage PPH in community-based settings. Misoprostol, a uterotonic that has been used as prophylaxis at the household level and has also been proven to be effective in treating PPH in hospital settings, is one possible option. METHODS: A double-blind, randomized placebo-controlled trial was conducted in six districts in Badakhshan Province, Afghanistan to test the effectiveness and safety of administering 800mcg sublingual misoprostol to women after a home birth for treatment of excessive blood loss. Consenting women were enrolled prior to delivery and given 600mcg misoprostol to self-administer orally as prophylaxis. Community health workers (CHW) were trained to observe for signs of PPH after delivery and if PPH was diagnosed, administer the study medication (misoprostol or placebo) and immediately refer the woman. A hemoglobin (Hb) decline of 2 g/dL or greater, measured pre- and post-delivery, served as the primary outcome; side effects, additional interventions, and transfer rates were also analyzed. RESULTS: Among the 1884 women who delivered at home, nearly all (98.7%) reported self-use of misoprostol for PPH prevention. A small fraction was diagnosed with PPH (4.4%, 82/1884) and was administered treatment. Hb outcomes, including the proportion of women with a Hb drop of 2 g/dL or greater, were similar between the study groups (misoprostol: 56.4% (22/39), placebo: 60.6% (20/33), p = 0.45). Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03). Other side effects were similar between study groups and none required treatment, including among the subset of 39 women, who received misoprostol for both of its PPH indications. CONCLUSIONS: While the study did not document a clinical benefit associated with misoprostol for treatment of PPH, study findings suggest that use of misoprostol for both prevention and treatment in the same birth as well as its use by lay level providers in home births does not result in any safety concerns. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov, number NCT01508429 Registered on December 1, 2011.

Management of the third stage of labour: (for the Optimal Intrapartum Care series edited by Mercedes Bonet, Femi Oladapo and Metin Gülmezoglu).

The physiology of the third stage of labour is described. Active management reduces the risk of postpartum haemorrhage (PPH), due to the use of a uterotonic agent. Intramuscular Oxytocin 10 IU has the highest efficacy and lowest side effect profile, although ergometrine, carbetocin and misoprostol are also effective. The appropriate uterotonic in different settings such as home birth by unskilled attendants and at caesarean section is discussed. For the latter, there is less consensus on the optimal dose/route of oxytocin, this topic remaining on the research agenda. Delayed cord clamping enables transfusion of blood to the neonate and is recommended rather than early clamping. Controlled cord traction should only be performed by skilled birth attendants and confers minimal advantage in preventing retained placenta. The importance of early recognition of PPH, and preparedness, is emphasised. An approach to medical and surgical management of PPH is presented.

Texas women's decisions and experiences regarding self-managed abortion.

BACKGROUND: Prior research has shown that a small proportion of U.S. women attempt to self-manage their abortion. The objective of this study is to describe Texas women's motivations for and experiences with attempts to self-manage an abortion. The objective of this study is to describe Texas women's motivations for and experiences with attempts to self-manage an abortion. METHODS: We report results from two data sources: two waves of surveys with women seeking abortion services at Texas facilities in 2012 and 2014 and qualitative interviews with women who reported attempting to self-manage their abortion while living in Texas at some time between 2009 and 2014. We report the prevalence of attempted self-managed abortion for the current pregnancy among survey respondents, and describe interview participants' decision-making and experiences with abortion self-management. RESULTS: 6.9% (95% CI 5.2-9.0%) of abortion clients (n = 721) reported they had tried to end their current pregnancy on their own before coming to the clinic for an abortion. Interview participants (n = 18) described multiple reasons for their decision to attempt to self-manage abortion. No single reason was enough for any participant to consider self-managing their abortion; however, poverty intersected with and layered upon other obstacles to leave them feeling they had no other option. Ten interview participants reported having a complete abortion after taking medications, most of which was identified as misoprostol. None of the six women who used home remedies alone reported having a successful abortion; many described using these methods for several days or weeks which ultimately did not work, resulting in delays for some, greater distress, and higher costs. CONCLUSION: These findings point to a need to ensure that women who may consider self-managed abortion have accurate information about effective methods, what to expect in the process, and where to go for questions and follow-up care. There is increasing evidence that given accurate information and access to clinical consultation, self-managed abortion is as safe as clinic-based abortion care and that many women find it acceptable, while others may prefer to use clinic-based abortion care.

Midwives and Post-abortion Care in Gabon: "Things have really changed".

Complications from spontaneous and induced abortion are a primary cause of death of women in sub-Saharan Africa. Le Réseau d'Afrique Centrale pour la Santé Reproductive des Femmes: Gabon, Cameroun, Guinée Équatoriale (the Middle African Network for Women's Reproductive Health, or GCG as it is commonly known) was founded in 2009 to identify and overcome obstacles to post-abortion care in Gabon. Research identified the main obstacle as lack of emergency skills and provisions among first-line health care providers. To fill the lacuna, GCG designed a program to train midwives in manual vacuum aspiration (MVA), misoprostol protocols, and the insertion of T-shaped copper IUDs. This article presents a nine-year retrospective (2009-2018) of the program. Qualitative and quantitative results confirm correlations between midwives' practice of MVA in health centers and spectacular decreases in treatment delays, with corresponding decreases in mortality from abortion complications. Our findings also demonstrate how these advances have been threatened by opposition to midwife practice in certain urban medical centers despite encouragement by the Gabon Ministry of Health to use the new protocols. Women's human right to the highest attainable standard of health, including access to safe abortion, is an assumption that GCG shares with the 40 African countries that have ratified the Protocol to the African Charter on Human and Peoples' Rights on the Rights of Women in Africa. The training program illustrates how a direct-action strategy can fully equip medical practitioners, especially those in peripheral sites with meager resources, to provide emergency post-abortion and abortion care even before governments legislate their human rights commitment.

Challenges and Successes of Distributing Birth Kits with Misoprostol to Reduce Maternal Mortality in Rural Tanzania.

The Saving Mothers Project was conducted from September 2015 to March 2017 in Bunda and Tarime Districts, Mara Region, Tanzania. The purpose of this project was to train community health workers (CHWs) to use mobile phones applications to register and educate pregnant women about safe deliveries and encourage them to access skilled health care providers for antenatal care and delivery, and to provide nurses and CHWs with clean birth kits with misoprostol to distribute to women. The birth kits were for use in case women could not access the health facility, or if the health facility was lacking supplies at the time of delivery. The overall goal of the study was to reduce the maternal mortality rate by increasing women's access to health services where possible, and to clean supplies when a non-facility birth was unavoidable. This paper reports on a mixed methods evaluation of the project including a survey of over two thousand four hundred women, and focus groups with women, community health workers, and nurses participating in the project. The results of the survey and focus groups demonstrate a high degree of satisfaction with the birth kits and misoprostol and an increase in facility birth rates where the project was implemented. Differences between the two districts illustrate that policy maker support is key to successful implementation.

Misoprostol, Magnesium Sulphate and Anti-shock garment: A knowledge, availability and utilization study at the Primary Health Care Level in Western Nigeria.

INTRODUCTION: Nigeria has one of the highest maternal mortality ratios in the world. The nurses and midwives being the first point of contact play a central role in addressing these problems. This study was conducted to assess the knowledge and utilization of the technologies (misoprostol, anti-shock garment and magnesium sulphate) in the reduction of maternal mortality amongst the Primary Health Care (PHC) nurses and midwives in Lagos State, Nigeria. In addition, the availability of the technologies in the flagship Primary Health Centres (PHCs) was assessed. METHODS: This was a cross-sectional study among all the nurses and midwives at the flagship PHCs in Lagos state and a total of 230 were eventually studied. Data was collected using a self-administered, structured questionnaire and a checklist. Descriptive and inferential statistics were applied. Level of significance was set at 5% (p<0.05). RESULTS: All the respondents were aware of the technologies but most (73.9%) had poor knowledge of them. Majority (74.8%) of the respondents had good knowledge of maternal mortality and its major causes. Most, 81.3% of the respondents have administered misoprostol, 37.0% magnesium sulphate while 52.2% have administered anti shock garment. Out of the 57 flagship PHCs, 27 (47.4%) had magnesium sulphate, 42 (73.7%) had misoprostol and 52 (91.2%) had anti-shock garments in their facilities. Respondents who were double qualified (nurse/midwife) had significantly better knowledge of maternal mortality and its major causes (p = 0.009) than the other cadres. Longer years of experience (p = 0.019), training in the use of misoprostol (p = 0.020) and training in the use of magnesium sulphate (p = 0.001) significantly improved knowledge of the technologies. CONCLUSION: Respondents had good knowledge of maternal mortality and its major causes and poor knowledge of the technologies for maternal mortality reduction, despite the trainings attended. Of the three technologies considered, misoprostol was the most commonly used. Periodic refresher courses for the training and retraining of PHC nurses and midwives on the technologies for maternal mortality reduction is recommended.

Using misoprostol to treat postpartum hemorrhage in home deliveries attended by traditional birth attendants.

OBJECTIVE: To explore the clinical and programmatic feasibility of using 800 µg of sublingual misoprostol to prevent and treat postpartum hemorrhage (PPH) during home delivery. METHODS: The present double-blind randomized controlled trial included women who underwent home deliveries in Chitral district, Khyber Pakhtunkhwa province, Pakistan, after presenting at healthcare facilities during the third trimester of pregnancy between May 28, 2012, and November 27, 2014. Participants were randomized in a 1:1 ratio to receive either 800 µg of misoprostol or placebo sublingually if PPH was diagnosed, having previously received a prophylactic oral dose of 600 µg misoprostol. The primary outcome, hemoglobin decrease of 20 g/L or greater from pre- to post-delivery assessment, was compared on a modified intention-to-treat basis. RESULTS: There were 49 patients allocated to receive misoprostol and 38 allocated to receive placebo; the incidence of a 20 g/L decrease in hemoglobin was similar between the groups (20/43 [47%] vs 19/33 [58%], respectively; P=0.335). CONCLUSION: There was no significant difference in clinical outcomes between the two trial arms. ClinicalTrials.gov:NCT01485562.

"My job is to get pregnant women to the hospital": a qualitative study of the role of traditional birth attendants in the distribution of misoprostol to prevent post-partum haemorrhage in two provinces in Mozambique.

BACKGROUND: Post-partum haemorrhage is the leading cause of maternal deaths in Mozambique. In 2015, the Mozambican Ministry of Health launched the National Strategy for the Prevention of Post-Partum Haemorrhage at the Community Level. The strategy included the distribution of misoprostol to women in advance at antenatal care and via Traditional Birth Attendants who directly administer the medication. The study explores the role of Traditional Birth Attendants in the misoprostol program and the views of women who used misoprostol to prevent post-partum haemorrhage. METHODS: This descriptive study collected data through in-depth interviews and focus group discussions. Traditional Birth Attendants between the ages of 30-70 and women of reproductive age participated in the study. Data was collected between June-October 2017 in Inhambane and Nampula Provinces. Line by line thematic analysis was used to interpret the data using Nvivo (v.11). RESULTS: The majority of TBAs in the study were satisfied with their role in the misoprostol program and were motivated to work with the formal health system to encourage women to access facility based births. Women who used misoprostol were also satisfied with the medication and encouraged family and friends to access it when needed. Women in the community and Traditional Birth Attendants requested assistance with transportation to reach the health facility to avoid home births. CONCLUSIONS: This study contributes to the evidence base that Traditional Birth Attendants are an appropriate channel for the distribution of misoprostol for the prevention of post-partum haemorrhage at the community level. More support and resources are needed to ensure Traditional Birth Attendants can assist women to have safe births when they are unable to reach the health facility. A consistent supply of misoprostol is needed to ensure women at the community level receive this life saving medication.

Pharmacological and mechanical interventions for labour induction in outpatient settings.

BACKGROUND: Induction of labour is carried out for a variety of indications and using a range of methods. For women at low risk of pregnancy complications, some methods of induction of labour or cervical ripening may be suitable for use in outpatient settings. OBJECTIVES: To examine pharmacological and mechanical interventions to induce labour or ripen the cervix in outpatient settings in terms of effectiveness, maternal satisfaction, healthcare costs and, where information is available, safety. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016) and reference lists of retrieved studies. SELECTION CRITERIA: We included randomised controlled trials examining outpatient cervical ripening or induction of labour with pharmacological agents or mechanical methods. Cluster trials were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed evidence using the GRADE approach. MAIN RESULTS: This updated review included 34 studies of 11 different methods for labour induction with 5003 randomised women, where women received treatment at home or were sent home after initial treatment and monitoring in hospital.Studies examined vaginal and intracervical prostaglandin E2 (PGE2), vaginal and oral misoprostol, isosorbide mononitrate, mifepristone, oestrogens, amniotomy and acupuncture, compared with placebo, no treatment, or routine care. Trials generally recruited healthy women with a term pregnancy. The risk of bias was mostly low or unclear, however, in 16 trials blinding was unclear or not attempted. In general, limited data were available on the review's main and additional outcomes. Evidence was graded low to moderate quality. 1. Vaginal PGE2 versus expectant management or placebo (5 studies)Fewer women in the vaginal PGE2 group needed additional induction agents to induce labour, however, confidence intervals were wide (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.27 to 0.99; 150 women; 2 trials). There were no clear differences between groups in uterine hyperstimulation (with or without fetal heart rate (FHR) changes) (RR 3.76, 95% CI 0.64 to 22.24; 244 women; 4 studies; low-quality evidence), caesarean section (RR 0.80, 95% CI 0.49 to 1.31; 288 women; 4 studies; low-quality evidence), or admission to a neonatal intensive care unit (NICU) (RR 0.32, 95% CI 0.10 to 1.03; 230 infants; 3 studies; low-quality evidence).There was no information on vaginal birth within 24, 48 or 72 hours, length of hospital stay, use of emergency services or maternal or caregiver satisfaction. Serious maternal and neonatal morbidity or deaths were not reported. 2. Intracervical PGE2 versus expectant management or placebo (7 studies) There was no clear difference between women receiving intracervical PGE2 and no treatment or placebo in terms of need for additional induction agents (RR 0.98, 95% CI 0.74 to 1.32; 445 women; 3 studies), vaginal birth not achieved within 48 to 72 hours (RR 0.83, 95% CI 0.68 to 1.02; 43 women; 1 study; low-quality evidence), uterine hyperstimulation (with FHR changes) (RR 2.66, 95% CI 0.63 to 11.25; 488 women; 4 studies; low-quality evidence), caesarean section (RR 0.90, 95% CI 0.72 to 1.12; 674 women; 7 studies; moderate-quality evidence), or babies admitted to NICU (RR 1.61, 95% CI 0.43 to 6.05; 215 infants; 3 studies; low-quality evidence). There were no uterine ruptures in either the PGE2 group or placebo group.There was no information on vaginal birth not achieved within 24 hours, length of hospital stay, use of emergency services, mother or caregiver satisfaction, or serious morbidity or neonatal morbidity or perinatal death. 3. Vaginal misoprostol versus placebo (4 studies)One small study reported on the rate of perinatal death with no clear differences between groups; there were no deaths in the treatment group compared with one stillbirth (reason not reported) in the control group (RR 0.34, 95% CI 0.01 to 8.14; 77 infants; 1 study; low-quality evidence).There was no clear difference between groups in rates of uterine hyperstimulation with FHR changes (RR 1.97, 95% CI 0.43 to 9.00; 265 women; 3 studies; low-quality evidence), caesarean section (RR 0.94, 95% CI 0.61 to 1.46; 325 women; 4 studies; low-quality evidence), and babies admitted to NICU (RR 0.89, 95% CI 0.54 to 1.47; 325 infants; 4 studies; low-quality evidence).There was no information on vaginal birth not achieved within 24, 48 or 72 hours, additional induction agents required, length of hospital stay, use of emergency services, mother or caregiver satisfaction, serious maternal, and other neonatal, morbidity or death.No substantive differences were found for other comparisons. One small study found that women who received oral misoprostol were more likely to give birth within 24 hours (RR 0.65, 95% CI 0.48 to 0.86; 87 women; 1 study) and were less likely to require additional induction agents (RR 0.60, 95% CI 0.37 to 0.97; 127 women; 2 studies). Women who received mifepristone were also less likely to require additional induction agents (average RR 0.59, 95% CI 0.37 to 0.95; 311 women; 4 studies; I² = 74%); however, this result should be interpreted with caution due to high heterogeneity. One trial each of acupuncture and outpatient amniotomy were included, but few review outcomes were reported. AUTHORS' CONCLUSIONS: Induction of labour in outpatient settings appears feasible and important adverse events seem rare, however, in general there is insufficient evidence to detect differences. There was no strong evidence that agents used to induce labour in outpatient settings had an impact (positive or negative) on maternal or neonatal health. There was some evidence that compared to placebo or no treatment, induction agents administered on an outpatient basis reduced the need for further interventions to induce labour, and shortened the interval from intervention to birth.We do not have sufficient evidence to know which induction methods are preferred by women, the interventions that are most effective and safe to use in outpatient settings, or their cost effectiveness. Further studies where various women-friendly outpatient protocols are compared head-to-head are required. As part of such work, women should be consulted on what sort of management they would prefer.

Updates to the US Food and Drug Administration Regulations for Mifepristone: Implications for Clinical Practice and Access to Abortion.

This article provides information on recent changes in the US Food and Drug Administration (FDA) labeling and safety regulations for mifepristone (Mifeprex). The revised label now permits midwives, advanced practice nurses, and physician assistants to order and prescribe mifepristone, eliminating the requirement for physician supervision. The updated label also extends eligibility for use from 49 to 70 days' gestation and decreases the number of required visits from 3 to 2. The recommended dose of mifepristone has been reduced, and the dosage, timing, and route of administration for misoprostol have also been changed to reflect current research. These changes have implications for clinical practice and may lead to expanded access for women in the United States.

Women's perceptions of induction of labour outcomes: Results of an online-survey in Germany.

OBJECTIVE: induction of labour (IOL) is a common procedure in high income countries. It may be conducted for medical as well as non-medical reasons. Women's views on induction of labour have not extensively been evaluated as yet. Also, women's preferences for certain methods of induction including alternative and complementary methods need further exploration in order to meet their expectations and needs. DESIGN AND SETTING: we published a short online questionnaire on women'views and experiences with IOL. MEASUREMENTS AND FINDINGS: we asked for indication and gestational age at induction; method of induction, duration of labour and mode of birth. We also asked for the extent of desired, and experienced support and participation in decision-making. Within four weeks of being online, 698 women answered the questionnaire. Most frequent reasons for induction were postmaturity (51.7%), doctor's recommendation (31.6%) and medical complications (25.6%). Most women were induced with misoprostol or dinoprostone, but nearly half of the respondents were also offered, or asked for, complementary and alternative methods (CAM). 50% or more women would have preferred more information on alternatives to IOL, methods of IOL, side effects of the drugs, information on alternatives (59.2%) and on the medication (55.3%). Many would have wished for more support (49.9%) with decision-making (55.2%), and more time (54.1%). KEY CONCLUSION: women' expectations and needs regarding IOL are widely unmet in current clinical practice. IMPLICATIONS FOR PRACTICE: there is a need for evidence-based information and decisional support for pregnant women who need to decide how to proceed once term is reached.

Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial.

BACKGROUND: Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. METHODS: We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3-21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 µg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratified by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov, number NCT01713153. FINDINGS: 28 maternity hut clusters were randomly assigned-14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group and 2·7 g/L (SD 17·8) in the oxytocin group. When adjusted for cluster design, the mean difference in haemoglobin decreases between groups was not significant (0·3 g/L, 95% CI -8·26 to 8·92, p=0·71). Both drugs were well tolerated. Shivering was common in the misoprostol group, and nausea in the oxytocin group. Postpartum haemorrhage was diagnosed in one woman allocated to oxytocin, who was referred and transferred to a higher-level facility for additional care, and fully recovered. No other women were transferred. INTERPRETATION: In terms of effects on haemoglobin concentrations, neither oxytocin nor misoprostol was significantly better than the other, and both drugs were safe and efficacious when delivered by auxiliary midwives. The programmatic limitations of oxytocin, including short shelf life outside the cold chain, mean that misoprostol could be more appropriate for community-level prophylaxis of postpartum haemorrhage. FUNDING: Bill & Melinda Gates Foundation.

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.

Outpatient cervical ripening.

Induction of labor is one of the most commonly performed obstetric procedures. Many patients undergoing labor induction require cervical ripening. In an era where cost and patient satisfaction have become paramount, the idea of outpatient cervical ripening is appealing; provided it can be performed in a safe and cost effective manner. The ideal agent would induce adequate cervical ripening without causing significant uterine contractions/labor. Various methods have been studied including administration of misoprostol, PGE2, nitric oxide donors, use of Foley balloon catheters and acupuncture. Each method has its strengths and limitations; however, larger studies of outpatient cervical ripening that are specifically powered for rare adverse maternal and fetal outcomes are needed before definitive recommendations can be made.

Haemoglobin status and predictors of anaemia among pregnant women in Mpigi, Uganda.

BACKGROUND: Anaemia in pregnancy is a major public health problem especially in the low-income countries where it is highly prevalent. There has been no recent study in Uganda about the factors associated with anaemia in pregnancy. We aimed to assess the current haemoglobin (Hb) status and factors associated with anaemia (Hb < 11.0 g/dl) in pregnant women in Mpigi, Uganda. METHODS: We assessed Hb levels of 2436 pregnant women at 28+ weeks of gestation at six health facilities, who were approached to participate in a stepped-wedge cluster-randomised trial of antenatal distribution of misoprostol (for self-administration after home birth or when oxytocin is not available). Women were administered a questionnaire and their baseline blood haemoglobin was examined using portable HemoCueR Hb 301 system. Predictors of anaemia were estimated using linear and logistic regression analysis. RESULTS: The mean Hb was 11.5 (± 1.38) g/dl and prevalence of anaemia (Hb < 11.0 g/dl) was 32.5% (95% CI 30.6%, 34.3%). After adjusting for measured confounders, factors associated with increased risk of anaemia in pregnancy were malaria infection (OR: 1.32, 95% CI: 1.11, 1.58), Human Immuno-deficiency Virus infection (OR: 2.13, 95% CI: 1.36, 2.90) and lack of iron supplementation (OR: 1.66, 95% CI: 1.36, 2.03). Intermittent presumptive treatment of malaria, maternal age and parity showed a weak association with anaemia in pregnancy CONCLUSION: The high prevalence of anaemia in pregnancy in our setting highlights the need to put more effort in the fight against malaria and HIV, and also ensure that pregnant women access iron supplements early in pregnancy.

Community-level distribution of misoprostol to prevent postpartum hemorrhage at home births in northern Nigeria.

In Nigeria, most deaths due to postpartum hemorrhage (PPH) occur in the absence of skilled birth attendants. A study using community mobilization and the training of community drug keepers to increase access to misoprostol for PPH prevention was conducted in five communities around Zaria in Kaduna State, Nigeria. Community-oriented resource persons (CORPs) and traditional birth attendants (TBAs) recruited and counseled pregnant women on bleeding after delivery, the importance of delivery at a health facility, and the role of misoprostol. Drug keepers stored and dispensed misoprostol during a woman's third trimester of pregnancy. TBAs and CORPs enrolled 1,875 women from January through December 2009. These results are based on 1,577 completed postpartum interviews. Almost all women delivered at home (95%) and skilled attendance at delivery was low (7%). The availability of misoprostol protected 83% of women who delivered at home against PPH who otherwise would not have been protected. Policymakers working in similar contexts should consider utilizing commuity-level distribution models to reach women with this life-saving intervention.

Decentralizing postabortion care in Senegal with misoprostol for incomplete abortion.

OBJECTIVE: To expand access to postabortion care (PAC) services in Senegal by introducing misoprostol as a first-line treatment at the community level. METHODS: The present prospective study enrolled 481 women seeking treatment for incomplete abortion at 11 community health posts in Senegal between September 2011 and August 2012. Participants were given 400 µg of sublingual misoprostol and asked to return to the clinic 1 week later to confirm clinical status. At study completion, all women were asked to respond to a series of questions regarding their experience with this method. All care was provided by nurse midwives. RESULTS: All but three of the study women (99.4%; 474/477) had successful complete abortion after taking misoprostol. Almost all women were satisfied or very satisfied with the treatment (99.6%; 469/471), would select the method again if needed (98.9%; 465/470), and would recommend the method to a friend (99.8%; 468/469). CONCLUSION: The results provide further evidence that 400 µg of misoprostol is highly effective for first-line treatment of incomplete abortion. Furthermore, this regimen can be fully provided by nurse midwives, and can be easily and successfully introduced in community health settings where other methods of PAC may not previously have been available. Clinicaltrials.gov: NCT01939457.

Achievements of the FIGO Initiative for the Prevention of Unsafe Abortion and its Consequences in South-Southeast Asia.

Since 2008, the FIGO Initiative for the Prevention of Unsafe Abortion and its Consequences has contributed to ensuring the substitution of sharp curettage by manual vacuum aspiration (MVA) and medical abortion in selected hospitals in participating countries of South-Southeast Asia. This initiative facilitated the registration of misoprostol in Pakistan and Bangladesh, and the approval of mifepristone for "menstrual regulation" in Bangladesh. The Pakistan Nursing Council agreed to include MVA and medical abortion in the midwifery curriculum. The Bangladesh Government has approved the training of nurses and paramedics in the use of MVA to treat incomplete abortion in selected cases. The Sri Lanka College of Obstetricians and Gynaecologists, in collaboration with partners, has presented a draft petition to the relevant authorities appealing for them to liberalize the abortion law in cases of rape and incest or when lethal congenital abnormalities are present. Significantly, the initiative has introduced or strengthened the provision of postabortion contraception.

A randomized controlled study of the efficacy of misoprostol and hyaluronic acid in preventing adhesion formation after gynecological surgery: a rat uterine horn model.

OBJECTIVE: To investigate the effect of misoprostol in the reduction of adhesion formation after gynecological surgery. STUDY DESIGN: A double blind, randomized controlled experimental study was designed. Twenty-one female Wistar Hannover rats were divided into three groups as control, misoprostol and Hyalobarrier(®) groups. A uterine horn adhesion model was created. After anesthesia induction, 1.5-2cm injuries were made to the each uterine horn by cautery. The control group received no special medications except for the standard surgical procedure. The misoprostol group received 10µcg/kg misoprostol in addition to the standard surgical procedure, and the Hyalobarrier(®) group received 1cm(3) ready-for-use Hyalobarrier(®) gel intraperitoneally in addition to the standard surgical procedure. After 14 days from the first surgical procedure, adhesion scores were evaluated. RESULTS: The extent (p<0.001), severity (p<0.001), degree (p<0.001) and total adhesion score (p<0.001) values of the control group were statistically higher than the values of misoprostol and Hyalobarrier(®) groups. The inflammation score value of misoprostol group was statistically lower than control and Hyalobarrier(®) groups (p<0.001). CONCLUSION: In this study, we have found a new therapeutic potential of misoprostol that may be useful in preventing pelvic adhesion and reducing inflammation scores.

Mucosal protective agents prevent exacerbation of NSAID-induced small intestinal lesions caused by antisecretory drugs in rats.

Antisecretory drugs such as histamine H2-receptor antagonists and proton pump inhibitors are commonly used for the treatment of upper gastrointestinal mucosal lesions induced by nonsteroidal anti-inflammatory drugs (NSAIDs). However, it has recently been reported that these drugs exacerbate NSAID-induced small intestinal lesions in rats. Unfortunately, there are few effective agents for the treatment of this complication. We examined the effects of mucosal protective agents (MPAs) (misoprostol, irsogladine, and rebamipide) and mucin of porcine stomach on diclofenac-induced intestinal lesions and the exacerbation of the lesions by ranitidine or omeprazole. The effects of the drugs on intestinal motility and mucus distribution/content were also examined. Male Wistar rats (180-220 g) were used. Each drug was administered orally under fed conditions. Diclofenac (1-10 mg/kg) produced multiple lesions in the small intestine dose-dependently. Both ranitidine (30 mg/kg) and omeprazole (100 mg/kg) significantly increased the intestinal lesions induced by low doses (3 and 6 mg/kg) of diclofenac. Misoprostol (0.03-0.3 mg/kg), irsogladine (3-30 mg/kg), and rebamipide (30-300 mg/kg), as well as mucin (30-300 mg/kg) inhibited the formation of intestinal lesions caused by a high dose (10 mg/kg) of diclofenac alone and prevented the exacerbation of diclofenac-induced lesions by antisecretory drugs. Diclofenac (10 mg/kg) markedly increased the intestinal motility and decreased the mucosal mucus, and the decrease of mucus was significantly inhibited by the MPAs. These results indicate the usefulness of the MPAs for the treatment of intestinal lesions induced by NSAIDs alone or by coadministration with antisecretory drugs, and suggest that mucus plays an important role in the protection of intestinal mucosa by the MPAs.