Project to Use Community Health Workers to Reduce Maternal Deaths

NCT03024905 | Completed

• 1 other identifier: 108026
• Study Type: interventional
• Target: 17,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Mortality; Access to Health Care

Outcome Measures

Primary Outcomes (1)

• Facility births

  Number of women attending health facilities for delivery

  During baseline vs during intervention periods until end of study (2 years)

Secondary Outcomes (4)

• Antenatal Care visits

  During baseline vs during intervention until end of study (2 years)

• Postpartum visits

  During baseline vs during intervention until end of study (2 years)

• Use of transport intervention

  During Intervention until end of study (2 years)

• Use of birth kit

  During Intervention until end of study (2 years)

Study Arms (4)

Division 1

EXPERIMENTAL

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; Device: Birth kit with misoprostol

Division 2

EXPERIMENTAL

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; Device: Birth kit with misoprostol

Division 3

EXPERIMENTAL

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; Device: Birth kit with misoprostol

Division 4

EXPERIMENTAL

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; Device: Birth kit with misoprostol

Interventions

Village meeting and travel vouchers BEHAVIORAL

The interventions are: 1. Village meetings by community health workers to educate women and their families about safe birthing. 2. Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.

Division 1; Division 2; Division 3; Division 4

Birth kit with misoprostol DEVICE

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).

Division 1; Division 2; Division 3; Division 4

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women must be pregnant.
• Women must live in Rorya District, but not in Shirati Town.
• Women must deliver in Rorya District .

You may not qualify if:

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

Sponsors & Collaborators

• Bruyère Health Research Institute.: lead
• Ottawa Hospital Research Institute: collaborator
• Shirati KMT Hospital: collaborator

Study Sites (1)

Shirati District Hospital Research Office

Shirati, Rorya District, Mara, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 35086508 DERIVED

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bwire Chirangi, MPH

  Director of Shirati KMT Hospital

  PRINCIPAL INVESTIGATOR

• Gail C Webber, MD, PhD

  Bruyère Health Research Institute.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: December 11, 2016
• First Posted: January 19, 2017
• Study Start: January 16, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)