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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Society for Applied Studies.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT01699945
First received: September 27, 2012
Last updated: October 1, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Maternal Deaths
Neonatal Deaths
Still Births
Other: This is an observational study being conducted as a substudy of antoher trial.

Study Type: Observational
Study Design: Time Perspective: Retrospective
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 Improvement (AMANHI)

Resource links provided by NLM:


Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • Burden of maternal and neonatal death and still births [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 730
Study Start Date: August 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699945

Contacts
Contact: Sarmila Mazumder, PhD 011-46043751-55 ext 401 CHRD@sas.org.in

Locations
India
CHRD, Society for Applied Studies Recruiting
Faridabad, Haryana, India, 121004
Contact: Sarmila Mazumder, PhD    011-46043751-55 ext 401    CHRD@sas.org.in   
Principal Investigator: Sarmila Mazumder, PhD         
Sponsors and Collaborators
Society for Applied Studies
World Health Organization
Investigators
Principal Investigator: Sarmila Mazumder, PhD CHRD, Society for Applied Studies
  More Information

No publications provided

Responsible Party: Society for Applied Studies
ClinicalTrials.gov Identifier: NCT01699945     History of Changes
Other Study ID Numbers: RPC532(India)
Study First Received: September 27, 2012
Last Updated: October 1, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Society for Applied Studies:
Verbal autopsies
Maternal deaths
Still births

Additional relevant MeSH terms:
Death
Maternal Death
Pathologic Processes
Pregnancy Complications
Parental Death

ClinicalTrials.gov processed this record on September 30, 2014