CompletedNot Applicable

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

India2,258 participantsStarted 2012-08

Plain-language 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.

Who can participate

Age range

15 Years – 49 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All deaths Exclusion Criteria: * Non consent for verbal autopsy All deaths of women in reproductive age group and all still births in specified window period for whom the respondents have given consent to provide information.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Burden of maternal and neonatal death and still births

Timeframe: 2 years

Timing of maternal and neonatal death and still births

Timeframe: 2 Years

Causes of maternal and neonatal death and still births

Timeframe: 2 Years

Trial details

NCT IDNCT01699945

SponsorSociety for Applied Studies

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Maternal Deaths trials