Clinical trial NCT01487707: Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria
Official title: Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Mortality
Keywords: pregnancy
maternal mortality
neonatal mortality
community intervention
voluntary health worker
safe birth kit
maternal child health
Lead sponsor: Abdul Latif Jameel Poverty Action Lab
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation Nigeria
name: MacArthur Foundation
First posted: 2011-12-07
Enrollment: 7200
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Women of reproductive age who live in the study clusters who provide consent.

Exclusion Criteria:

* Eligible women who do not consent.

Primary outcomes:
measure: Maternal Mortality Ratio
timeFrame: 42 days post delivery
Secondary outcomes:
measure: Maternal Morbidity Rates
timeFrame: 42 days post delivery
measure: Proportion of women delivering in a health facility
timeFrame: 2 years
measure: Neonatal Mortality Rate
timeFrame: 28 days after birth
measure: Proportion of women receiving antenatal care during pregnancy
timeFrame: 2 years
measure: Knowledge of warning signs during pregnancy
timeFrame: 2 years
measure: Proportion of women/newborns receiving postnatal care
timeFrame: 2 years
measure: Birthweight
timeFrame: 2 years
measure: Stunting, underweight and wasting in children under 5 years
timeFrame: 2 years
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: Planned Parenthood Federation
Study officials:
affiliation: Massachusetts Institute of Technology
name: Jessica Leight, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts Institute of Technology
name: Vandana Sharma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stockholm School of Economics
name: Martina Bjorkman-Nyqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma V, Leight J, AbdulAziz F, Giroux N, Nyqvist MB. Illness recognition, decision-making, and care-seeking for maternal and newborn complications: a qualitative study in Jigawa State, Northern Nigeria. J Health Popul Nutr. 2017 Dec 21;36(Suppl 1):46. doi: 10.1186/s41043-017-0124-y.
citation: Sharma V, Brown W, Kainuwa MA, Leight J, Nyqvist MB. High maternal mortality in Jigawa State, Northern Nigeria estimated using the sisterhood method. BMC Pregnancy Childbirth. 2017 Jun 2;17(1):163. doi: 10.1186/s12884-017-1341-5.