NCT01699945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,258

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

September 27, 2012

Last Update Submit

October 28, 2016

Conditions

Maternal DeathsNeonatal DeathsStill Births

Keywords

Verbal autopsiesMaternal deathsStill births

Outcome Measures

Primary Outcomes (3)

  • Burden of maternal and neonatal death and still births

    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.

    2 years

  • Timing of maternal and neonatal death and still births

    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.

    2 Years

  • Causes of maternal and neonatal death and still births

    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.

    2 Years

Study Arms (1)

Verbal Autopsies

The study involves filling of verbal autopsies for still births and deaths in women of reproductive age group.

Other: This is an observational study being conducted as a substudy of antoher trial.

Interventions

This is an observational study being conducted as a substudy of antoher trial.OTHER
Verbal Autopsies

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted in the same study areas and population as the parent study. The participants in this study will be pregnant women identified through surveillance among all women of reproductive age in the population where the parent study is being conducted, and their newborn infants. The parent study is not conducting an intervention related to maternal health or stillbirths. Therefore, the results of the AMANHI study related to maternal and stillbirth outcomes are not likely to be influenced by what happens in the parent study. However, only the control group in the parent study will be considered for analysis of neonatal deaths in this observational study.

You may qualify if:

  • All deaths

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRD, Society for Applied Studies

Faridabad, Haryana, 121004, India

Location

MeSH Terms

Conditions

Maternal DeathPerinatal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Sarmila Mazumder, PhD

    CHRD, Society for Applied Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2012

First Posted

October 4, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

IN(1)