Maternal DeathNCT03363308
Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa
A study testing training for health care workers supplmented by QI teams in people with Maternal Death and Infant Death, run by Jhpiego at 1 site in Democratic Republic of the Congo.
Trial summary
The aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maternal Death, Infant Death, Stillbirth
- What is being tested?
- training for health care workers supplmented by QI teams
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 16 Nov 2017to 30 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Health providers:
- Currently on the roster of maternity ward providers working at one of the 16 selected facilities at the time of the training module.
- Willing to attend a Jhpiego clinical training workshop and offer consent as study participant.
- Age 18 or older.
Who cannot join
- there are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Jhpiego DRC
Kinshasa
About this study
Official title: Effects of a Health Workforce Capacity Building and Quality Improvement Intervention on Intrapartum Stillbirth, Early Newborn Mortality and Post-pregnancy Family Planning in Kinshasa: a Cluster Randomized Evaluation
The aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.
Read the detailed description
The health workforce capacity building and quality improvement intervention will be implemented in two phases: eight facilities will receive the intervention in phase 1 and the remaining eight facilities will receive the intervention in phase 2.
Objective 1: For objective 2 on facility-based health outcomes, the study design is a cluster-randomized evaluation in phase 1. The intervention's effects will be assessed by comparing an intervention group and a control group of facilities. These will be selected from 16 Kinshasa health facilities. Intervention and control facilities' monthly reported health outcomes will be compared in a 12-month baseline period and 12-month period during and after the intervention implementation (Phase 1) in a difference-in-difference analysis. In Phase 2, all facilities will have their monthly service statistics and health outcomes reviewed for trends in improvement.
Overall, in Phase 1, eight intervention sites will be matched to eight sites serving as controls. In Phase 2, the eight Phase 1 control sites will then receive the same package as the intervention sites in Phase 1. Sites will be stratified by case load, low and high (over 90 births per month), and funding (public or private funding). Within each stratum, prior to start of the intervention, there will be random selection to intervention and control groups to allow for baseline comparability between groups.
- Conditions
- Maternal Death, Infant Death, Stillbirth
- Being tested
- training for health care workers supplmented by QI teams
- Medical subject headings
- Maternal Death, Infant Death, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training for health care workers supplmented by QI teamsBehavioural
Also called Practice coordinator training after training session, Practice sessions using anatomic models, SMS reminder messages and quizzes, Routine calls between mentors and providers
Jhpiego will deliver maternal and newborn health and family planning (MNH+FP) training using evidence-based low-dose, high-frequency (LDHF) learning approaches and support hospital staff-led quality improvement efforts to increase the coverage of facility-based high-impact interventions, including care of the mother and newborn on the day of birth and through the first week postpartum and post abortion services.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | training for health care workers supplemented by QI teams Receives: Behavioral: training for health care workers supplmented by QI teams |
| Phase 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number or percent of items correctly answered
Each observed structured clinical exam (OSCE) or knowledge tests has between 13 and 38 items. A participant needs to achieve 85% correct score to pass at post-training to assess provider competencies. The main indicator for analysis will be the mean number of items (or percent of items) correctly answered. This mean percent of items correctly answered will be done pre-training, post-training and after 6 months. This will be done in the 8 intervention group facilities only in Phase I and again in the 8 new facilities in Phase II.
Measured: 1 day
Intrapartum perinatal death ratio
Defined as death of a fetus during labor who had heart tones documented on arrival in the maternity and neonatal deaths prior to 24 hours, divided by total births.
Measured: 1 day
Percent of women after childbirth who adopt a family planning method immediately post-pregnancy or intend to adopt a method by six weeks post-pregnancy.
Percent of women after childbirth who adopt a family planning method over all women who give birth in a facility
Measured: 3 days
Secondary outcomes (1)
maternal mortality
number of maternal deaths over number of live births
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start16 Nov 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DeathStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster-randomized trial in phase I and interrupted time series in phase II
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Virgile Kikaya, Principal investigator, Jhpiego DRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363308
- Sponsor's protocol ID
- OPP1156220
- Status last verified
- Jul 2020
- First submitted
- 30 Nov 2017
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Health Workforce Capacity Building and Quality Improvement Intervention on Intrapartum Stillbirth, Early Newborn Mortality and Post-pregnancy Family Planning in Kinshasa: a Cluster Randomized Evaluation
- ClinicalTrials.gov ID
- NCT03363308
- Acronym / sponsor ID
- OPP1156220
- Conditions
- Maternal Death, Infant Death, Stillbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Dec 2017 (actual)
- 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 aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.
Detailed description
The health workforce capacity building and quality improvement intervention will be implemented in two phases: eight facilities will receive the intervention in phase 1 and the remaining eight facilities will receive the intervention in phase 2.
Objective 1: For objective 2 on facility-based health outcomes, the study design is a cluster-randomized evaluation in phase 1. The intervention's effects will be assessed by comparing an intervention group and a control group of facilities. These will be selected from 16 Kinshasa health facilities. Intervention and control facilities' monthly reported health outcomes will be compared in a 12-month baseline period and 12-month period during and after the intervention implementation (Phase 1) in a difference-in-difference analysis. In Phase 2, all facilities will have their monthly service statistics and health outcomes reviewed for trends in improvement.
Overall, in Phase 1, eight intervention sites will be matched to eight sites serving as controls. In Phase 2, the eight Phase 1 control sites will then receive the same package as the intervention sites in Phase 1. Sites will be stratified by case load, low and high (over 90 births per month), and funding (public or private funding). Within each stratum, prior to start of the intervention, there will be random selection to intervention and control groups to allow for baseline comparability between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster-randomized trial in phase I and interrupted time series in phase II
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Behavioral: training for health care workers supplmented by QI teamstraining for health care workers supplemented by QI teams |
| Phase 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Health providers:
Key exclusion criteria (1 listed)
- there are no exclusion criteria
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 |
|---|---|---|
| training for health care workers supplmented by QI teamsAlso: Practice coordinator training after training session, Practice sessions using anatomic models, SMS reminder messages and quizzes, Routine calls between mentors and providersJhpiego will deliver maternal and newborn health and family planning (MNH+FP) training using evidence-based low-dose, high-frequency (LDHF) learning approaches and support hospital staff-led quality improvement efforts to increase the coverage of facility-based high-impact interventions, including care of the mother and newborn on the day of birth and through the first week postpartum and post abortion services. | Behavioural | Phase 1 |
Primary outcome
Mean number or percent of items correctly answered
Time frame: 1 day
Each observed structured clinical exam (OSCE) or knowledge tests has between 13 and 38 items. A participant needs to achieve 85% correct score to pass at post-training to assess provider competencies. The main indicator for analysis will be the mean number of items (or percent of items) correctly answered. This mean percent of items correctly answered will be done pre-training, post-training and after 6 months. This will be done in the 8 intervention group facilities only in Phase I and again in the 8 new facilities in Phase II.
Intrapartum perinatal death ratio
Time frame: 1 day
Defined as death of a fetus during labor who had heart tones documented on arrival in the maternity and neonatal deaths prior to 24 hours, divided by total births.
Percent of women after childbirth who adopt a family planning method immediately post-pregnancy or intend to adopt a method by six weeks post-pregnancy.
Time frame: 3 days
Percent of women after childbirth who adopt a family planning method over all women who give birth in a facility
1 secondary outcome
maternal mortality
Time frame: 3 days
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 24 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Maternal Death
Enrolling by invitation
Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Not yet recruiting
Improving Maternal and Neonatal Care-seeking Through a Video-informed Training Session During the Third Trimester of Pregnancy
Maternal Health, Neonatal Health
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.
Virgile Kikaya principal investigator
Jhpiego DRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training for health care workers supplmented by QI teams in people with Maternal Death and Infant Death, run by Jhpiego at 1 site in Democratic Republic of the Congo.
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 4 inclusion and 1 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 24 Jul 2020. 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 Democratic Republic of the Congo. 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?
Mean number or percent of items correctly answered (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2020.