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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

Tracking Information
First Submitted Date  ICMJE December 11, 2016
First Posted Date  ICMJE January 19, 2017
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE January 16, 2017
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
Facility births [ Time Frame: During baseline vs during intervention periods until end of study (2 years) ]
Number of women attending health facilities for delivery
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03024905 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
  • 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
  • Postpartum visits [ Time Frame: During baseline vs during intervention until end of study (2 years) ]
    Number of women attending health facility for postpartum visits
  • Use of transport intervention [ Time Frame: During Intervention until end of study (2 years) ]
    Number of women using the free transport intervention
  • Use of birth kit [ Time Frame: During Intervention until end of study (2 years) ]
    Number of women using the birth kit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project to Use Community Health Workers to Reduce Maternal Deaths
Official Title  ICMJE Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Maternal Mortality
  • Access to Health Care
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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).

    Interventions:
    • 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).

    Interventions:
    • 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).

    Interventions:
    • 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).

    Interventions:
    • Behavioral: Village meeting and travel vouchers
    • Device: Birth kit with misoprostol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 18, 2017)
17000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03024905
Other Study ID Numbers  ICMJE 108026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gail Webber, Bruyere Research Institute
Study Sponsor  ICMJE Bruyere Research Institute
Collaborators  ICMJE
  • Ottawa Hospital Research Institute
  • Shirati KMT Hospital
Investigators  ICMJE
Principal Investigator: Bwire Chirangi, MPH Director of Shirati KMT Hospital
Principal Investigator: Gail C Webber, MD, PhD Bruyere Research Institute
PRS Account Bruyere Research Institute
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP