Clinical Trial: Using Ongoing Newborn Intervention Trials to Obtain Additional Data Critical to Maternal, Fetal and Newborn Health in a Harmonized Way

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Using Ongoing Newborn Intervention Trials to Obtain Additional Data Critical to Maternal, Fetal and Newborn Health in a Harmonized Way: The AMANHI* Study *Alliance for Maternal and Newborn Health Impr

Brief Summary:

The goal of this study is to generate unique information to guide improvements on interventions to reduce maternal and newborn mortality as well as prevent stillbirths.

The objective of this study is to determine the burden, timing, and causes of maternal deaths, stillbirths and neonatal deaths.

This will be an observational study where data will be collected retrospectively in the context of the ongoing study in Haryana, India.

Women of reproductive age living in the study area have already been enumerated for the parent studies. Active surveillance is being conducted for identifying pregnancies and deaths among women of reproductive age in the population through 3 monthly home visitations.

Verbal autopsies will be conducted for all deaths of women in the reproductive age, including those who died in pregnancy, childbirth and up to 42-60 days after childbirth. Verbal autopsy interviews will also be conducted for all stillbirths.

Detailed Summary:

RATIONAL & BACKGROUND INFORMATION

Among the Millennium Development Goals, those that aim to reach significant reductions in maternal and child mortality have been proving the hardest to achieve.

Most maternal and neonatal deaths are caused by a few conditions, and majority of them are preventable with currently available, effective interventions. About a third of stillbirths occur in the intrapartum period, integrally related to the availability and quality of essential and emergency childbirth services. Effective interventions to reduce maternal deaths, stillbirths and newborn and child deaths reach less than half the pregnant women, mothers, newborns and children who need them. Information on mortality and morbidity as well as health care delivery is largely available only from surveys, which have inherent methodological issues that limit validity. Vital registration information and reliable information from the health system is missing in the same countries where the burden of mortality is the highest and health care is least accessible. This leads to underestimates of the magnitude of the problem with negative implications for the prioritization of interventions to scale-up.

The BMGF and WHO are supporting a set of large intervention trials that will follow cohorts of pregnant women and newborns to document the impact of the interventions. These trials provide a unique opportunity to address additional questions relevant for improving maternal, newborn and child health (MNCH) programs and for addressing the above-mentioned gaps in data.

STUDY GOALS AND OBJECTIVES Goal

The study will be conducted as a part of the large ongoing parent study on newborn health research in
Sponsor: Society for Applied Studies

Current Primary Outcome:

• Burden of maternal and neonatal death and still births [ Time Frame: 2 years ]
  The parent study is already collecting information on the burden, timing and causes of neonatal deaths and an estimate of maternal deaths and still births. The proposed additional study presents a unique opportunity to estimate population-based burden, timing, and causes of maternal deaths and stillbirths.
• Timing of maternal and neonatal death and still births [ Time Frame: 2 Years ]
  The parent study is already collecting information on the burden, timing and causes of neonatal deaths and an estimate of maternal deaths and still births. The proposed additional study presents a unique opportunity to estimate population-based burden, timing, and causes of maternal deaths and stillbirths.
• Causes of maternal and neonatal death and still births [ Time Frame: 2 Years ]
  The parent study is already collecting information on the burden, timing and causes of neonatal deaths and an estimate of maternal deaths and still births. The proposed additional study presents a unique opportunity to estimate population-based burden, timing, and causes of maternal deaths and stillbirths.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Society for Applied Studies

Dates:
Date Received: September 27, 2012
Date Started: August 2012
Date Completion:
Last Updated: October 28, 2016
Last Verified: October 2016