Effectiveness and acceptability of a 24-h interval versus a 48-h interval between mifepristone intake and misoprostol administration for in-hospital abortion at 9-20 gestational weeks: an international, open-label, randomised, controlled, non-inferiority trial.

Background: Optimising management of second-trimester medical abortion is important, as complications increase with gestational age. We aimed to compare a 24-h interval with a 48-h interval between mifepristone intake and misoprostol administration in in-hospital, second-trimester medical abortion for effectiveness and acceptability.

Methods: This open-label, randomised, controlled, non-inferiority trial was conducted at nine hospitals in India, Sweden, Thailand, and Viet Nam among adults undergoing medical abortion for a singleton viable pregnancy at a gestation of between 9 weeks and 20 weeks.

Research agenda for ending preventable maternal deaths from postpartum haemorrhage: a WHO research prioritisation exercise.

Introduction: Postpartum haemorrhage (PPH) remains the leading cause of maternal death. Yet there is a lack of clarity around what research is needed to determine what works and how best to deliver proven PPH interventions. This article describes a WHO-led effort to develop a global PPH research agenda for 2023-2030, to reinvigorate research and innovation while avoiding duplication and waste.

Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people.

Systematic under-representation of pregnant women and gender diverse pregnant people in clinical research has prevented them from benefitting fairly from biomedical advances. The resulting lack of pharmacological safety and efficacy data leads to medicine discontinuation, sub-optimal dosing, and reliance on repurposed therapies. We identify four roadblocks to fair inclusion.

The effects of proton pump inhibitors during pregnancy on treatment of preeclampsia and related outcomes: a systematic review and meta-analysis.

Objective: This systematic review evaluated the available evidence on the effects of proton pump inhibitors during pregnancy on preeclampsia and related maternal, fetal, and neonatal outcomes.

Data Sources: Five electronic databases (MEDLINE, Embase, CINAHL, Cochrane Central Register of Controlled Trials, and Global Medicus Index) were searched on November 17, 2023.

Study Eligibility Criteria: Randomized controlled trials of pregnant women who used any class or dose of proton pump inhibitor were eligible.

Modeling the economic burden of postpartum hemorrhage due to substandard uterotonics in Ghana.

Uterotonics are essential in preventing postpartum hemorrhage (PPH), the leading direct cause of maternal death worldwide. However, uterotonics are often substandard in low- and middle-income countries, contributing to poor maternal health outcomes. This study examines the health and economic impact of substandard uterotonics in Ghana.

The drug drought in maternal health: an ongoing predicament.

We developed a comprehensive database of medicines that are used or are being investigated for pre-eclampsia or eclampsia, preterm birth or labour, postpartum haemorrhage, intrauterine growth restriction, and fetal distress and that were in active development between 2000 and 2021. A total of 444 candidates were identified: approximately half of candidates were in active development, two-thirds had been repurposed after initially being used for another condition, and just under half were in preclinical studies. Only 64 candidates were in active late-stage (phase 3) development as of Oct 25, 2021, and given the slow pace of biomedical development, it could take years before any of these products eventually make it to market.

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.

Background: Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal-fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem.

Methods And Findings: We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating women in vaccine and therapeutic clinical trials in any setting.

The effects of probiotics administration during pregnancy on preeclampsia and associated maternal, fetal, and newborn outcomes: a systematic review and meta-analysis.

Objective: This study aimed to synthesize the available evidence on probiotic administration during pregnancy for the prevention of preeclampsia and its effects on related maternal, fetal, and newborn outcomes.

Data Sources: Six databases were systematically searched for eligible studies, namely Ovid MEDLINE, Embase, CINAHL, Cochrane, Global Index Medicus, and the Maternity and Infant Care Database, from inception to August 2, 2023.

Study Eligibility Criteria: Randomized controlled trials that evaluated the effects of probiotic administration on women during any stage of pregnancy were eligible for inclusion.

Quality testing of mifepristone and misoprostol in 11 countries.

Objective: Previous studies have demonstrated quality concerns with misoprostol. Mifepristone, however, has not been extensively assessed for quality. Between 2020 and 2021, Concept Foundation and the International Planned Parenthood Federation conducted a study to determine the quality of these medical abortion drugs in low- and middle-income countries (LMIC).

New medicines for spontaneous preterm birth prevention and preterm labour management: landscape analysis of the medicine development pipeline.

Background: There are few medicines in clinical use for managing preterm labor or preventing spontaneous preterm birth from occurring. We previously developed two target product profiles (TPPs) for medicines to prevent spontaneous preterm birth and manage preterm labor. The objectives of this study were to 1) analyse the research and development pipeline of medicines for preterm birth and 2) compare these medicines to target product profiles for spontaneous preterm birth to identify the most promising candidates.

Self-care interventions for preconception, antenatal, intrapartum and postpartum care: a scoping review.

Objective: To identify current and emerging self-care interventions to improve maternity healthcare.

Design: Scoping review.

Data Sources: MEDLINE, Embase, EmCare, PsycINFO, Cochrane CENTRAL/CDSR, CINAHL Plus (last searched on 17 October 2021).

Target product profiles for novel medicines to prevent and treat preeclampsia: An expert consensus.

Background: Preeclampsia and eclampsia are a leading cause of global maternal and newborn mortality. Currently, there are few effective medicines that can prevent or treat preeclampsia. Target Product Profiles (TPPs) are important tools for driving new product development by specifying upfront the characteristics that new products should take.

The compatibility of oxytocin and tranexamic acid injection products when mixed for co-administration by infusion for the treatment of postpartum haemorrhage: An in vitro investigation.

Objective: To investigate the compatibility of oxytocin and tranexamic acid injection products when mixed for the purpose of co-administration by intravenous infusion.

Design: Compatibility testing.

Setting: Hospitals taking part in a multicentre postpartum haemorrhage treatment (E-MOTIVE) trial in Kenya, Nigeria, Tanzania and South Africa.

Analysis of a maternal health medicines pipeline database 2000-2021: New candidates for the prevention and treatment of fetal growth restriction.

Objective: The Accelerating Innovation for Mothers project established a new database of candidate medicines under development between 2000 and 2021 for five pregnancy-related conditions, including fetal growth restriction. The objective was to assess medicines for fetal growth restriction and their potential for clinical use globally.

Design: Landscape analysis.

Systematic evaluation of the pre-eclampsia drugs, dietary supplements and biologicals pipeline using target product profiles.

Background: The Accelerating Innovation for Mothers (AIM) project established a database of candidate medicines in research and development (R&D) between 2000 and 2021 for five pregnancy-related conditions, including pre-eclampsia. In parallel, we published target product profiles (TPPs) that describe optimal characteristics of medicines for use in preventing/treating pre-eclampsia. The study objective was to use systematic double screening and extraction to identify all candidate medicines being investigated for pre-eclampsia prevention/treatment and rank their potential based on the TPPs.

Expert consensus on novel medicines to prevent preterm birth and manage preterm labour: Target product profiles.

Objective: To develop target product profiles (TPPs) for new medicines for preterm birth prevention and preterm labour management that address the real-world need of women and healthcare providers, informed by views and agreement amongst globally diverse stakeholders.

Design: Mixed methods.

Setting: Global (with a focus on low- and middle-income countries, LMICs).

Reclassifying contraceptives as over-the-counter medicines to improve access.

Self-care interventions include over-the-counter contraceptives, which enable individuals to make informed, autonomous decisions about fertility management. As there is a substantial unmet need for contraception in many countries, increasing access by establishing sound, affordable and effective regulation of over-the-counter contraceptives could help reduce unintended pregnancies and improve maternal health. We performed a review of 30 globally diverse countries: (i) to assess national regulatory procedures for changing oral contraceptives, emergency contraceptives and injectable contraceptives from prescription-only to over-the-counter products; and (ii) to determine whether national lists of over-the-counter medicines included contraceptives.

Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania.

Objective: To check the quality of oxytocin and tranexamic acid-two recommended products for prevention and treatment of postpartum hemorrhage (PPH)-used in facilities taking part in an implementation research project to improve PPH diagnosis and management.

Methods: Between September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards.

Innovations in the prevention and treatment of postpartum hemorrhage: Analysis of a novel medicines development pipeline database.

Background: A significant barrier to improving prevention and treatment of postpartum hemorrhage (PPH) is a lack of innovative medicines that meet the needs of women and providers, particularly those in low-and middle-income countries (LMICs). The Accelerating Innovation for Mothers (AIM) project established a new database of candidate medicines under development for five pregnancy-related conditions between 2000 and 2021.

Objective: To systematically identify and rank candidates for prevention and treatment of PPH.

Challenges in updating national guidelines and essential medicines lists in Sub-Saharan African countries to include WHO-recommended postpartum hemorrhage medicines.

Despite the 2017 WHO recommendations on tranexamic acid (TXA) for the treatment of postpartum hemorrhage (PPH), the 2018 uterotonic recommendations (which included heat-stable carbetocin (HSC) for the prevention of PPH) and their inclusion in the WHO Essential Medicines List (EML), both drugs are still underused or not used at all to manage PPH in many countries with a high burden. HSC is currently being registered in low- and middle-income countries and its policy inclusion is limited and slow. TXA (also heat stable) is available in many countries but is not registered for PPH treatment, which may have contributed to the delay in its inclusion in national guidelines and EMLs.

Duration of third stage labour and postpartum blood loss: a secondary analysis of the WHO CHAMPION trial data.

Background: Obstetric haemorrhage continues to be a leading cause of maternal mortality, contributing to more than a quarter of the 2,443,000 maternal deaths reported between 2003 and 2009. During this period, about 70% of the haemorrhagic deaths occurred postpartum. In addition to other identifiable risk factors for greater postpartum blood loss, the duration of the third stage of labour (TSL) seems to be important, as literature shows that a longer TSL can be associated with more blood loss.

Effect of heat stable carbetocin vs oxytocin for preventing postpartum haemorrhage on post delivery hemoglobin-a randomized controlled trial.

Objective: To compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level.

Setting: Hospital based study in Southern India.

Population: Women delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India.