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CompletedNCT03024905EWHUpdated Aug 9, 2019

Project to Use Community Health Workers to Reduce Maternal Deaths

An interventional study of Village meeting and travel vouchers and Birth kit with misoprostol in Maternal Mortality and Access to Health Care, sponsored by Bruyère Health Research Institute.. Completed at 1 site in Tanzania. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-09.

Sponsored by Bruyère Health Research Institute. · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
17,000
Allocation
Randomized
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Maternal Mortality
  • Access to Health Care

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03

In context

Maternal Death

60 studies on the registry are indexed under Maternal Death; 17 are open to participants now.

This study's planned enrollment of 17,000 is above the median of 1,126 across 45 interventional studies indexed under Maternal Death.

Browse Maternal Death studies →

Lead sponsor

Bruyère Health Research Institute. is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17,000 participants (estimated)

Study arms

  • 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 · Device: Birth kit with misoprostol

  • 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 · Device: Birth kit with misoprostol

  • 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 · Device: Birth kit with misoprostol

  • 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 · Device: Birth kit with misoprostol

Interventions

  • BehavioralVillage 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.

  • DeviceBirth 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).

06

What researchers measure

Primary outcomes

  1. Facility births

    Number of women attending health facilities for delivery

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

Secondary outcomes

  1. Antenatal Care visits

    Number of times women attend health facility for antenatal visits

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

  2. Postpartum visits

    Number of women attending health facility for postpartum visits

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

  3. Use of transport intervention

    Number of women using the free transport intervention

    Time frame: During Intervention until end of study (2 years)

  4. Use of birth kit

    Number of women using the birth kit

    Time frame: During Intervention until end of study (2 years)

07

Study locations

1 site
  • Shirati District Hospital Research Office
    Shirati, Rorya District, Mara, Tanzania
08

References and documents

Publications

  • 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. PubMed 35086508 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03024905
Lead sponsor
Bruyère Health Research Institute.
Collaborators
Ottawa Hospital Research Institute, Shirati KMT Hospital
Responsible party
Gail Webber (Associate Scientist, Bruyère Health Research Institute.) — Principal investigator
First posted
Jan 19, 2017
Start date
Jan 16, 2017
Primary completion
May 2019
Completion
May 2019
Last update
Aug 9, 2019

Study contacts

Bwire Chirangi, MPH
principal investigator · Director of Shirati KMT Hospital
Gail C Webber, MD, PhD
principal investigator · Bruyère Health Research Institute.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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