Maternal MortalityEWHNCT03024905
Project to Use Community Health Workers to Reduce Maternal Deaths
A study testing Village meeting and travel vouchers and Birth kit with misoprostol in people with Maternal Mortality and Access to Health Care, run by Bruyère Health Research Institute. at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Mortality, Access to Health Care
- What is being tested?
- Village meeting and travel vouchers and Birth kit with misoprostol
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,000 participants
- Where
- 1 siteTanzania
- Study dates
- 16 Jan 2017to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women must be pregnant.
- Women must live in Rorya District, but not in Shirati Town.
- Women must deliver in Rorya District .
Who cannot join
- Women who live outside or deliver outside of Rorya District.
- Women who deliver preterm, before they have exposure to all the interventions.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Shirati District Hospital Research Office
Shirati, Rorya District, Mara
About this study
Official title: Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania
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.
- Conditions
- Maternal Mortality, Access to Health Care
- Being tested
- Village meeting and travel vouchers, Birth kit with misoprostol
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Village meeting and travel vouchersBehavioural
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 misoprostolDevice
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 group | Role | What they receive |
|---|---|---|
| Division 1 | Experimental | 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). Receives: Behavioral: Village meeting and travel vouchers; Device: Birth kit with misoprostol |
| Division 2 | Experimental | 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). Receives: Behavioral: Village meeting and travel vouchers; Device: Birth kit with misoprostol |
| Division 3 | Experimental | 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). Receives: Behavioral: Village meeting and travel vouchers; Device: Birth kit with misoprostol |
| Division 4 | Experimental | 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). Receives: Behavioral: Village meeting and travel vouchers; Device: Birth kit with misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facility births
Number of women attending health facilities for delivery
Measured: During baseline vs during intervention periods until end of study (2 years)
Secondary outcomes (4)
Antenatal Care visits
Number of times women attend health facility for antenatal visits
Measured: During baseline vs during intervention until end of study (2 years)
Postpartum visits
Number of women attending health facility for postpartum visits
Measured: During baseline vs during intervention until end of study (2 years)
Use of transport intervention
Number of women using the free transport intervention
Measured: During Intervention until end of study (2 years)
Use of birth kit
Number of women using the birth kit
Measured: During Intervention until end of study (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start16 Jan 2017
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Shirati KMT Hospital
- Responsible party
- Principal investigator, Gail Webber, Bruyère Health Research Institute.
- Investigators
- Bwire Chirangi, MPH, Principal investigator, Director of Shirati KMT HospitalGail C Webber, MD, PhD, Principal investigator, Bruyère Health Research Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024905
- Sponsor's protocol ID
- 108026
- Acronym
- EWH
- Status last verified
- Aug 2019
- First submitted
- 11 Dec 2016
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania
- ClinicalTrials.gov ID
- NCT03024905
- Acronym / sponsor ID
- EWH / 108026
- Conditions
- Maternal Mortality, Access to Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,000 participants (estimated)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Shirati KMT Hospital
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Division 1 | Experimental | Behavioral: Village meeting and travel vouchers, Device: Birth kit with misoprostolThe 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). |
| Division 2 | Experimental | Behavioral: Village meeting and travel vouchers, Device: Birth kit with misoprostolThe 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). |
| Division 3 | Experimental | Behavioral: Village meeting and travel vouchers, Device: Birth kit with misoprostolThe 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). |
| Division 4 | Experimental | Behavioral: Village meeting and travel vouchers, Device: Birth kit with misoprostolThe 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). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women must be pregnant.
- Women must live in Rorya District, but not in Shirati Town.
- Women must deliver in Rorya District .
Key exclusion criteria (2 listed)
- Women who live outside or deliver outside of Rorya District.
- Women who deliver preterm, before they have exposure to all the interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Village meeting and travel vouchersThe 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. | Behavioural | Division 1, Division 2, Division 3, Division 4 |
| Birth kit with misoprostolProvision 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). | Device | Division 1, Division 2, Division 3, Division 4 |
Primary outcome
Facility births
Time frame: During baseline vs during intervention periods until end of study (2 years)
Number of women attending health facilities for delivery
4 secondary outcomes
Antenatal Care visits
Time frame: During baseline vs during intervention until end of study (2 years)
Postpartum visits
Time frame: During baseline vs during intervention until end of study (2 years)
Use of transport intervention
Time frame: During Intervention until end of study (2 years)
Use of birth kit
Time frame: During Intervention until end of study (2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Derived from this study: PubMed 35086508Webber 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.
- Individual participant dataSharing planned: No
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The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
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Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Recruiting
The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity
Severe Maternal Morbidity, Maternal Death
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IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Postpartum Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bwire Chirangi, MPH principal investigator
Director of Shirati KMT Hospital
Gail C Webber, MD, PhD principal investigator
Bruyère Health Research Institute.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Village meeting and travel vouchers and Birth kit with misoprostol in people with Maternal Mortality and Access to Health Care, run by Bruyère Health Research Institute. at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facility births (time frame: During baseline vs during intervention periods until end of study (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03024905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.