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CompletedNCT01487707Updated Jan 15, 2019

Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

An interventional study of Voluntary Health Worker (VHW) Program and Safe Birth Kit in Maternal Mortality, sponsored by Abdul Latif Jameel Poverty Action Lab. Completed at 1 site in Nigeria. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Abdul Latif Jameel Poverty Action Lab · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
7,200
Allocation
Randomized
Ages
15 Years to 49 Years
Sex
Female
01

Study 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.
02

Conditions studied

  • Maternal Mortality

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Keywords

  • pregnancy
  • maternal mortality
  • neonatal mortality
  • community intervention
  • voluntary health worker
  • safe birth kit
  • maternal child health
03

In context

Maternal Death

77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.

This study's enrollment of 7,200 is above the median of 1,126 across 57 interventional studies indexed under Maternal Death.

Browse Maternal Death studies →

Lead sponsor

Abdul Latif Jameel Poverty Action Lab is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Eligible women who do not consent.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7,200 participants (actual)

Study arms

  • Experimental
    Voluntary Health Worker (VHW) Program

    Behavioral: Voluntary Health Worker (VHW) Program

  • Experimental
    VHW program plus Safe Birth Kit

    Behavioral: Voluntary Health Worker (VHW) Program · Behavioral: Safe Birth Kit

  • Experimental
    VHW program plus Folk Media Activities

    Behavioral: Voluntary Health Worker (VHW) Program · Behavioral: Community Folk Media Campaigns

Interventions

  • BehavioralVoluntary Health Worker (VHW) Program

    Voluntary Health Workers will conduct door-to-door campaigns on maternal and child health, and will visit pregnant women regularly to to educate and to encourage use of antenatal care and facility-based deliveries.

  • BehavioralSafe Birth Kit

    A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.

  • BehavioralCommunity Folk Media Campaigns

    Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.

06

What researchers measure

Primary outcomes

  1. Maternal Mortality Ratio

    Time frame: 42 days post delivery

Secondary outcomes

  1. Maternal Morbidity Rates

    Time frame: 42 days post delivery

  2. Proportion of women delivering in a health facility

    Time frame: 2 years

  3. Neonatal Mortality Rate

    Time frame: 28 days after birth

  4. Proportion of women receiving antenatal care during pregnancy

    Time frame: 2 years

  5. Knowledge of warning signs during pregnancy

    Time frame: 2 years

  6. Proportion of women/newborns receiving postnatal care

    Time frame: 2 years

  7. Birthweight

    Time frame: 2 years

  8. Stunting, underweight and wasting in children under 5 years

    Time frame: 2 years

07

Study locations

1 site
  • Planned Parenthood Federation
    Abuja, Nigeria
08

References and documents

Publications

  • 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. PubMed 29297412 ↗
  • 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. PubMed 28577546 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2011, a primary completion of Oct 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2011
First posted
Dec 7, 2011
Start
Dec 2011
Primary completionActual
Oct 2016
CompletionActual
Oct 2016
Last update
Jan 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01487707
Lead sponsor
Abdul Latif Jameel Poverty Action Lab
Collaborators
Planned Parenthood Federation Nigeria, MacArthur Foundation
Responsible party
Sponsor
First posted
Dec 7, 2011
Start date
Dec 2011
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Jan 15, 2019

Study contacts

Jessica Leight, PhD
principal investigator · Massachusetts Institute of Technology
Vandana Sharma, MD
principal investigator · Massachusetts Institute of Technology
Martina Bjorkman-Nyqvist, PhD
principal investigator · Stockholm School of Economics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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