Using Ongoing Newborn Intervention Trials to Obtain Additional Data Critical to Maternal, Fetal and Newborn Health in a Harmonized Way (AMANHI)
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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) |
- 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 |
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.
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| Contact: Sarmila Mazumder, PhD | 011-46043751-55 ext 401 | CHRD@sas.org.in |
| 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 | |
| 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 Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013