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

Bruyere Research Institute

Status: Completed

Conditions: Maternal Mortality; Access to Health Care

Treatments: Device: Birth kit with misoprostol; Behavioral: Village meeting and travel vouchers

Study type: Interventional

Funder types: Other

Identifiers

NCT03024905

108026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17,000 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17,000 participants in 4 patient groups

Division 1

Experimental group

Description:

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).

Treatment:

Device: Birth kit with misoprostol

Behavioral: Village meeting and travel vouchers

Division 2

Experimental group

Description:

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).

Treatment:

Device: Birth kit with misoprostol

Behavioral: Village meeting and travel vouchers

Division 3

Experimental group

Description:

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).

Treatment:

Device: Birth kit with misoprostol

Behavioral: Village meeting and travel vouchers

Division 4

Experimental group

Description:

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).

Treatment:

Device: Birth kit with misoprostol

Behavioral: Village meeting and travel vouchers