Project to Use Community Health Workers to Reduce Maternal Deaths (EWH)

Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania

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.

Study Overview

• Status: Completed
• Conditions: Maternal Mortality; Access to Health Care
• Intervention / Treatment: Behavioral: Village meeting and travel vouchers; Device: Birth kit with misoprostol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 17000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Mara Region
    • Shirati, Rorya District, Mara Region, Tanzania
      • Shirati District Hospital Research Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Division 1; The first division receives baseline data collection for 6 months then experiences interventions for the remainder of the trial. Interventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery. Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).	Behavioral: Village meeting and travel vouchers; The interventions are: Village meetings by community health workers to educate women and their families about safe birthing.; Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.; Device: Birth kit with misoprostol; Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).
Experimental: Division 2; The second division receives baseline data collection for 9 months then experiences interventions for the remainder of the trial. Interventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery. Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).	Behavioral: Village meeting and travel vouchers; The interventions are: Village meetings by community health workers to educate women and their families about safe birthing.; Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.; Device: Birth kit with misoprostol; Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).
Experimental: Division 3; The third division receives baseline data collection for 12 months then experiences interventions for the remainder of the trial. Interventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery. Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).	Behavioral: Village meeting and travel vouchers; The interventions are: Village meetings by community health workers to educate women and their families about safe birthing.; Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.; Device: Birth kit with misoprostol; Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).
Experimental: Division 4; The fourth division receives baseline data collection for 15 months then experiences interventions for the remainder of the trial. nterventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery. Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).	Behavioral: Village meeting and travel vouchers; The interventions are: Village meetings by community health workers to educate women and their families about safe birthing.; Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.; Device: Birth kit with misoprostol; Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facility births	Number of women attending health facilities for delivery	During baseline vs during intervention periods until end of study (2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antenatal Care visits	Number of times women attend health facility for antenatal visits	During baseline vs during intervention until end of study (2 years)
Postpartum visits	Number of women attending health facility for postpartum visits	During baseline vs during intervention until end of study (2 years)
Use of transport intervention	Number of women using the free transport intervention	During Intervention until end of study (2 years)
Use of birth kit	Number of women using the birth kit	During Intervention until end of study (2 years)

Collaborators and Investigators

• Sponsor: Bruyere Research Institute
• Collaborators: Ottawa Hospital Research Institute; Shirati KMT Hospital
• Investigators: Principal Investigator: Bwire Chirangi, MPH, Director of Shirati KMT Hospital; Principal Investigator: Gail C Webber, MD, PhD, Bruyere Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: December 11, 2016
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Parental Death; Maternal Death; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 108026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No