Increasing women's access to skilled pregnancy care to reduce maternal and perinatal mortality in rural Edo State, Nigeria: a randomized controlled trial.

BACKGROUND: Nigeria presently has the second highest absolute number of maternal deaths and perinatal deaths (stillbirth and neonatal deaths) in the world. The country accounts for up to 14% of global maternal deaths and is second only to India in the number of women who die during childbirth. Although all parts of the country are worsened by these staggering statistics, several lines of evidence show that most maternal, and perinatal deaths occur in the north-east and north-west geo-political zones where women have limited access to evidence-based maternal and neonatal health services. The proposed project intends to identify the demand and supply factors that prevent women from using PHCs for maternal and early new-born care in Nigeria, and to test innovative and community relevant interventions for improving women's access to PHC services, and thus, ultimately, to prevent maternal and perinatal deaths. METHODS: An open-labelled, randomized controlled trial will is carried out in two local government areas selected based on three criteria (i) maternal mortality rates (ii) PHC utilization rates and (iii) and geographic localization. The study will be conducted over 54-months in six communities, with PHCs in six communities of similar status serving as control sites. Surveys about quality of care and maternal health services utilization will be carried out at baseline, at midterm and at end of the project to test the effectiveness of the intervention, alongside conventional epidemiological measures of maternal and perinatal mortality. Ethical approval for the study has been granted (reference no. NHREC/01/01/2007). The findings will be published in compliance with reporting guidelines for randomized controlled trials. DISCUSSION: The current Federal Government in Nigeria has identified PHC as its main strategy for increasing access to health in Nigeria. However, despite numerous efforts, there are persisting concerns that there is currently no scientific evidence on which to base the improvement of PHCs. The results of this study will identify barriers in the use of PHCs and will provide scientific evidence for effective and innovative interventions for improving PHCs that can be rolled out throughout the country. TRIAL REGISTRATION: Clinical Trials.gov NCT02643953.

Implementing at-scale, community-based distribution of misoprostol tablets to mothers in the third stage of labor for the prevention of postpartum haemorrhage in Sokoto State, Nigeria: Early results and lessons learned.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of maternal death in Sokoto State, Nigeria, where 95% of women give birth outside of a health facility. Although pilot schemes have demonstrated the value of community-based distribution of misoprostol for the prevention of PPH, none have provided practical insight on taking such programs to scale. METHODS: A community-based system for the distribution of misoprostol tablets (in 600ug) and chlorhexidine digluconate gel 7.1% to mother-newborn dyads was introduced by state government officials and community leaders throughout Sokoto State in April 2013, with the potential to reach an estimated 190,467 annual births. A simple outcome form that collected distribution and consumption data was used to assess the percentage of mothers that received misoprostol at labor through December 2014. Mothers' conditions were tracked through 6 weeks postpartum. Verbal autopsies were conducted on associated maternal deaths. RESULTS: Misoprostol distribution was successfully introduced and reached mothers in labor in all 244 wards in Sokoto State. Community data collection systems were successfully operational in all 244 wards with reliable capacity to record maternal deaths. 70,982 women or 22% of expected births received misoprostol from April 2013 to December 2014. Between April and December 2013, 33 women (< 1%) reported that heavy bleeding persisted after misoprostol use and were promptly referred. There were a total of 11 deaths in the 2013 cohort which were confirmed as maternal deaths by verbal autopsies. Between January and December of 2014, a total 434 women (1.25%) that ingested misoprostol reported associated side effects. CONCLUSION: It is feasible and safe to utilize government guidelines on results-based primary health care to successfully introduce community distribution of life saving misoprostol at scale to reduce PPH and improve maternal outcomes. Lessons from Sokoto State's at-scale program implementation, to assure every mother's right to uterotonics, can inform scale-up elsewhere in Nigeria.