Clinical trial NCT03024905: Project to Use Community Health Workers to Reduce Maternal Deaths
Official title: Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Mortality
Access to Health Care
Lead sponsor: Bruyere Research Institute
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
name: Shirati KMT Hospital
First posted: 2017-01-19
Enrollment: 17000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this trial is to establish if several interventions will help women in rural Tanzania access health care services during pregnancy and at the time of delivery. The interventions include education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and supplies to be used either at the health facility, or on route if the women does not make it to the health facility.

Detailed description: In order to reduce the number of women dying in childbirth and to improve women's health in pregnancy, this trial is designed to assess if several interventions combined can increase the number of women delivering in health care facilities. The design of the study is "Multiple Baseline Design". Community health workers are trained to collect baseline data on women using mobile phones in one rural district in Tanzania. The district has four distinct divisions. After 6 months of baseline data in the district, one division will experience the interventions. The interventions are education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and birthing supplies to be used either at the health facility, or on route if the women does not make it to the health facility. The intervention will be begun in each of the other divisions in 3 month intervals (i.e. the second division starts to experience the interventions 3 months after the first, the third, 3 months after the second and the fourth 3 months after the third). The trial will continue for a total of 27 months including the baseline period.

Eligibility criteria: Inclusion Criteria:

1. Women must be pregnant.
2. Women must live in Rorya District, but not in Shirati Town.
3. Women must deliver in Rorya District .

Exclusion Criteria:

1. Women who live outside or deliver outside of Rorya District.
2. Women who deliver preterm, before they have exposure to all the interventions.

Primary outcomes:
measure: Facility births
timeFrame: During baseline vs during intervention periods until end of study (2 years)
Secondary outcomes:
measure: Antenatal Care visits
timeFrame: During baseline vs during intervention until end of study (2 years)
measure: Postpartum visits
timeFrame: During baseline vs during intervention until end of study (2 years)
measure: Use of transport intervention
timeFrame: During Intervention until end of study (2 years)
measure: Use of birth kit
timeFrame: During Intervention until end of study (2 years)
Other outcomes:
Locations:
city: Shirati, Rorya District
country: Tanzania
facility: Shirati District Hospital Research Office
state: Mara Region
Study officials:
affiliation: Director of Shirati KMT Hospital
name: Bwire Chirangi, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Bruyere Research Institute
name: Gail C Webber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Webber G, Chirangi B, Magatti N, Mallick R, Taljaard M. Improving health care facility birth rates in Rorya District, Tanzania: a multiple baseline trial. BMC Pregnancy Childbirth. 2022 Jan 27;22(1):74. doi: 10.1186/s12884-022-04408-5.