Maternal MortalityNCT01487707
Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria
A study testing Voluntary Health Worker (VHW) Program, Safe Birth Kit and Community Folk Media Campaigns in people with Maternal Mortality, run by Abdul Latif Jameel Poverty Action Lab at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Mortality
- What is being tested?
- Voluntary Health Worker (VHW) Program, Safe Birth Kit and Community Folk Media Campaigns
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 1 siteNigeria
- Study dates
- Dec 2011to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women of reproductive age who live in the study clusters who provide consent.
Who cannot join
- Eligible women who do not consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria
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:
- a Voluntary Health Worker Program (VHW)
- the VHW program with provision of a safe birth kit
- the VHW program with community folk media activities.
- Conditions
- Maternal Mortality
- Being tested
- Voluntary Health Worker (VHW) Program, Safe Birth Kit, Community Folk Media Campaigns
- Keywords
- pregnancy, maternal mortality, neonatal mortality, community intervention, voluntary health worker, safe birth kit, maternal child health
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluntary Health Worker (VHW) ProgramBehavioural
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.
Safe Birth KitBehavioural
A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.
Community Folk Media CampaignsBehavioural
Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.
| Study group | Role | What they receive |
|---|---|---|
| Voluntary Health Worker (VHW) Program | Experimental | Not described Receives: Behavioral: Voluntary Health Worker (VHW) Program |
| VHW program plus Safe Birth Kit | Experimental | Not described Receives: Behavioral: Voluntary Health Worker (VHW) Program; Behavioral: Safe Birth Kit |
| VHW program plus Folk Media Activities | Experimental | Not described Receives: Behavioral: Voluntary Health Worker (VHW) Program; Behavioral: Community Folk Media Campaigns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Mortality Ratio
Measured: 42 days post delivery
Secondary outcomes (8)
Maternal Morbidity Rates
Measured: 42 days post delivery
Proportion of women delivering in a health facility
Measured: 2 years
Neonatal Mortality Rate
Measured: 28 days after birth
Proportion of women receiving antenatal care during pregnancy
Measured: 2 years
Knowledge of warning signs during pregnancy
Measured: 2 years
Proportion of women/newborns receiving postnatal care
Measured: 2 years
Birthweight
Measured: 2 years
Stunting, underweight and wasting in children under 5 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdul Latif Jameel Poverty Action Lab
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Federation Nigeria, MacArthur Foundation
- Responsible party
- Sponsor
- Investigators
- Jessica Leight, PhD, Principal investigator, Massachusetts Institute of TechnologyVandana Sharma, MD, Principal investigator, Massachusetts Institute of TechnologyMartina Bjorkman-Nyqvist, PhD, Principal investigator, Stockholm School of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487707
- Sponsor's protocol ID
- 019368-001
- Status last verified
- Jan 2019
- First submitted
- 6 Dec 2011
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
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 29297412Sharma 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria
- ClinicalTrials.gov ID
- NCT01487707
- Acronym / sponsor ID
- 019368-001
- Conditions
- Maternal Mortality
- Keywords
- pregnancy, maternal mortality, neonatal mortality, community intervention, voluntary health worker, safe birth kit, maternal child health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,200 participants (actual)
- Lead sponsor
- Abdul Latif Jameel Poverty Action LabUniversity, hospital or other
- Collaborators
- Planned Parenthood Federation Nigeria, MacArthur Foundation
- Study start
- Dec 2011
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- a Voluntary Health Worker Program (VHW)
- the VHW program with provision of a safe birth kit
- the VHW program with community folk media activities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Voluntary Health Worker (VHW) Program | Experimental | Behavioral: Voluntary Health Worker (VHW) Program |
| VHW program plus Safe Birth Kit | Experimental | Behavioral: Voluntary Health Worker (VHW) Program, Behavioral: Safe Birth Kit |
| VHW program plus Folk Media Activities | Experimental | Behavioral: Voluntary Health Worker (VHW) Program, Behavioral: Community Folk Media Campaigns |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women of reproductive age who live in the study clusters who provide consent.
Key exclusion criteria (1 listed)
- Eligible women who do not consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voluntary Health Worker (VHW) ProgramVoluntary 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. | Behavioural | VHW program plus Folk Media Activities, VHW program plus Safe Birth Kit, Voluntary Health Worker (VHW) Program |
| Safe Birth KitA safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women. | Behavioural | VHW program plus Safe Birth Kit |
| Community Folk Media CampaignsCommunity-wide media activities, including dramas, intended to address community norms regarding maternal and child health. | Behavioural | VHW program plus Folk Media Activities |
Primary outcome
Maternal Mortality Ratio
Time frame: 42 days post delivery
8 secondary outcomes
Maternal Morbidity Rates
Time frame: 42 days post delivery
Proportion of women delivering in a health facility
Time frame: 2 years
Neonatal Mortality Rate
Time frame: 28 days after birth
Proportion of women receiving antenatal care during pregnancy
Time frame: 2 years
Knowledge of warning signs during pregnancy
Time frame: 2 years
Proportion of women/newborns receiving postnatal care
Time frame: 2 years
Birthweight
Time frame: 2 years
Stunting, underweight and wasting in children under 5 years
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 29297412Sharma 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.
- Derived from this study: PubMed 28577546Sharma 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.
Related trials for Maternal Mortality
Enrolling by invitation
Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Recruiting
The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity
Severe Maternal Morbidity, Maternal Death
Recruiting
IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Postpartum Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voluntary Health Worker (VHW) Program, Safe Birth Kit and Community Folk Media Campaigns in people with Maternal Mortality, run by Abdul Latif Jameel Poverty Action Lab at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Mortality Ratio (time frame: 42 days post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01487707, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.