Project to Use Community Health Workers to Reduce Maternal Deaths

Maternal Mortality Clinical Trial

— EWH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024905
• Other study ID #: 108026
• Status: Completed
• Phase: N/A
• Start date: January 16, 2017
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: Bruyere Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17000
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Access to Health Care
• Maternal Death
• Maternal Mortality

Intervention

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).

Locations

Country	Name	City	State
Tanzania	Shirati District Hospital Research Office	Shirati, Rorya District	Mara Region

Sponsors (3)

Lead Sponsor	Collaborator
Bruyere Research Institute	Ottawa Hospital Research Institute, Shirati KMT Hospital

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facility births	Number of women attending health facilities for delivery	During baseline vs during intervention periods until end of study (2 years)
Secondary	Antenatal Care visits	Number of times women attend health facility for antenatal visits	During baseline vs during intervention until end of study (2 years)
Secondary	Postpartum visits	Number of women attending health facility for postpartum visits	During baseline vs during intervention until end of study (2 years)
Secondary	Use of transport intervention	Number of women using the free transport intervention	During Intervention until end of study (2 years)
Secondary	Use of birth kit	Number of women using the birth kit	During Intervention until end of study (2 years)