Maternal Mortality Clinical Trial
Official title:
Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria
| NCT number | NCT01487707 |
| Other study ID # | 019368-001 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2011 |
| Est. completion date | October 2016 |
| Verified date | January 2019 |
| Source | Abdul Latif Jameel Poverty Action Lab |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this cluster randomized controlled trial is to assess the impact of several
community-based interventions that address the key factors underlying the high maternal
mortality, as well as neonatal mortality and morbidity in northern Nigeria. The
interventions, include:
1. a Voluntary Health Worker Program (VHW)
2. the VHW program with provision of a safe birth kit
3. the VHW program with community folk media activities.
| Status | Completed |
| Enrollment | 7200 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 15 Years to 49 Years |
| Eligibility |
Inclusion Criteria: - Women of reproductive age who live in the study clusters who provide consent. Exclusion Criteria: - Eligible women who do not consent. |
| Country | Name | City | State |
|---|---|---|---|
| Nigeria | Planned Parenthood Federation | Abuja |
| Lead Sponsor | Collaborator |
|---|---|
| Abdul Latif Jameel Poverty Action Lab | MacArthur Foundation, Planned Parenthood Federation Nigeria |
Nigeria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maternal Mortality Ratio | 42 days post delivery | ||
| Secondary | Maternal Morbidity Rates | 42 days post delivery | ||
| Secondary | Proportion of women delivering in a health facility | 2 years | ||
| Secondary | Neonatal Mortality Rate | 28 days after birth | ||
| Secondary | Proportion of women receiving antenatal care during pregnancy | 2 years | ||
| Secondary | Knowledge of warning signs during pregnancy | 2 years | ||
| Secondary | Proportion of women/newborns receiving postnatal care | 2 years | ||
| Secondary | Birthweight | 2 years | ||
| Secondary | Stunting, underweight and wasting in children under 5 years | 2 years |
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