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Completed

NCT Number: NCT03024905

Project to Use Community Health Workers to Reduce Maternal Deaths

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shirati District Hospital Research Office

Shirati, Rorya District, Mara, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Village meeting and travel vouchers

Behavioral

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.

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bruyère Health Research Institute.

Other

Collaborators

  • Ottawa Hospital Research Institute
  • Shirati KMT Hospital

Registry information

Official study title

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

Acronym: EWH

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2017
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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