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

Primary Purpose

Maternal Mortality, Access to Health Care

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Village meeting and travel vouchers
Birth kit with misoprostol
Sponsored by
Bruyere Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Mortality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Shirati District Hospital Research Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Division 1

Division 2

Division 3

Division 4

Arm 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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Facility births
Number of women attending health facilities for delivery

Secondary Outcome Measures

Antenatal Care visits
Number of times women attend health facility for antenatal visits
Postpartum visits
Number of women attending health facility for postpartum visits
Use of transport intervention
Number of women using the free transport intervention
Use of birth kit
Number of women using the birth kit

Full Information

First Posted
December 11, 2016
Last Updated
August 8, 2019
Sponsor
Bruyere Research Institute
Collaborators
Ottawa Hospital Research Institute, Shirati KMT Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03024905
Brief Title
Project to Use Community Health Workers to Reduce Maternal Deaths
Acronym
EWH
Official Title
Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bruyere Research Institute
Collaborators
Ottawa Hospital Research Institute, Shirati KMT Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Mortality, Access to Health Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Division 1
Arm Type
Experimental
Arm 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).
Arm Title
Division 2
Arm Type
Experimental
Arm 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).
Arm Title
Division 3
Arm Type
Experimental
Arm 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).
Arm Title
Division 4
Arm Type
Experimental
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Village meeting and travel vouchers
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Birth kit with misoprostol
Intervention Description
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).
Primary Outcome Measure Information:
Title
Facility births
Description
Number of women attending health facilities for delivery
Time Frame
During baseline vs during intervention periods until end of study (2 years)
Secondary Outcome Measure Information:
Title
Antenatal Care visits
Description
Number of times women attend health facility for antenatal visits
Time Frame
During baseline vs during intervention until end of study (2 years)
Title
Postpartum visits
Description
Number of women attending health facility for postpartum visits
Time Frame
During baseline vs during intervention until end of study (2 years)
Title
Use of transport intervention
Description
Number of women using the free transport intervention
Time Frame
During Intervention until end of study (2 years)
Title
Use of birth kit
Description
Number of women using the birth kit
Time Frame
During Intervention until end of study (2 years)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women must be pregnant. Women must live in Rorya District, but not in Shirati Town. Women must deliver in Rorya District . Exclusion Criteria: Women who live outside or deliver outside of Rorya District. Women who deliver preterm, before they have exposure to all the interventions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bwire Chirangi, MPH
Organizational Affiliation
Director of Shirati KMT Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gail C Webber, MD, PhD
Organizational Affiliation
Bruyere Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirati District Hospital Research Office
City
Shirati, Rorya District
State/Province
Mara Region
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35086508
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.
Results Reference
derived

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Project to Use Community Health Workers to Reduce Maternal Deaths

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