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

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ClinicalTrials.gov Identifier: NCT03024905
Recruitment Status : Completed
First Posted : January 19, 2017
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
Ottawa Hospital Research Institute
Shirati KMT Hospital
Information provided by (Responsible Party):
Gail Webber, Bruyere Research Institute

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.

Condition or disease Intervention/treatment Phase
Maternal Mortality Access to Health Care Behavioral: Village meeting and travel vouchers Device: Birth kit with misoprostol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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:

  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.

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:

  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.

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:

  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.

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:

  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.

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).




Primary Outcome Measures :
  1. Facility births [ Time Frame: During baseline vs during intervention periods until end of study (2 years) ]
    Number of women attending health facilities for delivery


Secondary Outcome Measures :
  1. Antenatal Care visits [ Time Frame: During baseline vs during intervention until end of study (2 years) ]
    Number of times women attend health facility for antenatal visits

  2. Postpartum visits [ Time Frame: During baseline vs during intervention until end of study (2 years) ]
    Number of women attending health facility for postpartum visits

  3. Use of transport intervention [ Time Frame: During Intervention until end of study (2 years) ]
    Number of women using the free transport intervention

  4. Use of birth kit [ Time Frame: During Intervention until end of study (2 years) ]
    Number of women using the birth kit



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024905


Locations
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Tanzania
Shirati District Hospital Research Office
Shirati, Rorya District, Mara Region, Tanzania
Sponsors and Collaborators
Bruyere Research Institute
Ottawa Hospital Research Institute
Shirati KMT Hospital
Investigators
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Principal Investigator: Bwire Chirangi, MPH Director of Shirati KMT Hospital
Principal Investigator: Gail C Webber, MD, PhD Bruyere Research Institute

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Responsible Party: Gail Webber, Associate Scientist, Bruyere Research Institute
ClinicalTrials.gov Identifier: NCT03024905     History of Changes
Other Study ID Numbers: 108026
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Maternal Death
Pregnancy Complications
Parental Death
Death
Pathologic Processes
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics