Postpartum HemorrhageNCT03254628
Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
A study testing Helping Mothers Survive - Bleeding After Birth training, Helping Babies Breathe and Mentor in people with Postpartum Hemorrhage and Neonatal Asphyxia, run by Jhpiego.
Trial summary
The study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and district level health facilities in Uganda. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postpartum Hemorrhage, Neonatal Asphyxia
- What is being tested?
- Helping Mothers Survive - Bleeding After Birth training, Helping Babies Breathe and Mentor
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,440 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2014to 31 Dec 2016
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For Providers: Health providers who attend births in participating health facility and consent to be assessed at the time of enrollment and at several points in time over two years.
- For Clinical mentors: being an experienced skilled birth attendant and likely to remain at the facility during the study period
- For Women in Labor and Delivery and Newborns: Women in any stage of labor in participating facility who consent to observation of their delivery and care of their newborn (or consent from the next of kin if the woman is incapacitated and not able to provide consent)
- Facility In-charges and Stakeholders: Facility in-charges at sampled health facilities; stakeholders identified by Jhpiego senior managers as being influential in maternal and newborn health policy decisions in Uganda.
Who cannot join
- Providers: has <1 year of experience, and has plans to be transferred to another facility or leave the facility soon
- Other types of participants: none
About this study
The study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and district level health facilities in Uganda. The program is designed to improve provider competencies, provider performance and health outcomes among women giving birth and newborns.
Read the detailed description
This study will take place in Uganda at Health Centers (level II, III and IV) and District Hospitals, to reach 'frontline' health providers who attend births. This study will take place in districts meeting study criteria in two regions to demonstrate ability to implement in different geographic settings and potential for scale up. It is a quasi-experimental design with three study arms/groups that receive different levels or intensities and modalities of the program intervention.
Briefly, the same simulator-based training will be provided in all three study arms. After the training, a simulator will be left in the health facility, and providers will be encouraged to practice with it regularly. In two of the study arms, specific health workers will be recruited to support the intervention by encouraging their colleagues to practice with the simulator. In one study arm, the practice will be further reinforced through mobile phone-based support. Following is a more detailed description of each of the three components.
Component 1 (Training): Training is composed of two separate training interventions. First, in each study facility, Ugandan master trainers (district trainers) will conduct a single day, simulator-driven training on PPH prevention and treatment; all providers who attend births will be invited to participate. Eight weeks later, in each facility, the same trainers will conduct a one-day, simulator-driven training for prevention and management of asphyxia in the newborn. After each one-day training, simulators will be left at the facility for practice with a corresponding practice schedule.
Component 2 (Peer-led Practice Sessions): On the day the first training (for PPH), 2 birth attendants at the facility will be selected to serve as clinical mentors (CM). The CMs will be trained to encourage their coworkers to participate in 15-minute practice sessions each week for 8 weeks, in which they will use the simulators to practice the skills learned in the one-day training. After the newborn asphyxia training occurs, these same CMs will be trained to support a similar practice schedule for the following 12 weeks - 8 weeks for newborn asphyxia practice and 4 weeks for combined PPH and asphyxia skills practice.
Component 3 (Mobile phone-based support): CMs will be connected to the district trainer via mobile phone for weekly phone calls during the practice periods to provide reminders and support for practice.
- Conditions
- Postpartum Hemorrhage, Neonatal Asphyxia
- Being tested
- Helping Mothers Survive - Bleeding After Birth training, Helping Babies Breathe, Mentor, Phone, oxytocin and misoprostol
- Medical subject headings
- Postpartum Hemorrhage, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helping Mothers Survive - Bleeding After Birth trainingOther
Also called HMS BAB
One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.
Helping Babies BreatheOther
Also called HBB
One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag \& mask device.
MentorBehavioural
Also called CM
A birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day.
PhoneBehavioural
District trainers telephone clinical mentors and encourage them to lead practice sessions.
oxytocin and misoprostolDrug
Also called oxy&miso
This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.
Newborn bag and maskDevice
Also called B&M
All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care
| Study group | Role | What they receive |
|---|---|---|
| Full - Train/oxy&miso/ B&M/Mentor/Phone | Experimental | Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor. Receives: Other: Helping Mothers Survive - Bleeding After Birth training; Other: Helping Babies Breathe; Behavioral: Mentor; Behavioral: Phone; Drug: oxytocin and misoprostol; Device: Newborn bag and mask |
| Partial - Train/oxy & miso/ B&M/Mentor | Experimental | Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice. Receives: Other: Helping Mothers Survive - Bleeding After Birth training; Other: Helping Babies Breathe; Behavioral: Mentor; Drug: oxytocin and misoprostol; Device: Newborn bag and mask |
| Comparison - Train/oxy & miso/ B&M | Active comparator | Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,. Receives: Other: Helping Mothers Survive - Bleeding After Birth training; Other: Helping Babies Breathe; Drug: oxytocin and misoprostol; Device: Newborn bag and mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage
The change in the percentage of women who received oxytocin in correct dose immediately after vaginal birth in three study arms, as assessed by direct clinical observation, using a standardized checklist.
Measured: Baseline, Midline (6 months), Endline (12 months)
Secondary outcomes (3)
Change in provider performance on simulator-based assessments
The proportion of providers that obtain a passing score on the assessments, based on assessments done by clinical trainers.
Measured: Pre-test (before training)- post-test (immediately after training) - midline (6 months)
Difference in differences: change in care of the mother composite score
A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.
Measured: Baseline (before training), Midline (6 months), Endline (12 months)
Difference in differences: change care of the newborn composite score
A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.
Measured: Baseline (before training), Midline (6 months), Endline (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start14 Nov 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- 3,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Cherrie Evans, DrPH, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254628
- Sponsor's protocol ID
- AID-OAA-A-13-00012
- Status last verified
- Aug 2017
- First submitted
- 20 Jul 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Williams E, Bazant ES, Holcombe S, Atukunda I, Namugerwa RI, Britt K, Evans C. "Practice so that the skill does not disappear": mixed methods evaluation of simulator-based learning for midwives in Uganda. Hum Resour Health. 2019 Mar 29;17(1):24. doi: 10.1186/s12960-019-0350-z.
PubMed 30925890Evans CL, Bazant E, Atukunda I, Williams E, Niermeyer S, Hiner C, Zahn R, Namugerwa R, Mbonye A, Mohan D. Peer-assisted learning after onsite, low-dose, high-frequency training and practice on simulators to prevent and treat postpartum hemorrhage and neonatal asphyxia: A pragmatic trial in 12 districts in Uganda. PLoS One. 2018 Dec 17;13(12):e0207909. doi: 10.1371/journal.pone.0207909. eCollection 2018.
PubMed 30557350
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
- ClinicalTrials.gov ID
- NCT03254628
- Acronym / sponsor ID
- AID-OAA-A-13-00012
- Conditions
- Postpartum Hemorrhage, Neonatal Asphyxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,440 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 14 Nov 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 18 Aug 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 study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and district level health facilities in Uganda. The program is designed to improve provider competencies, provider performance and health outcomes among women giving birth and newborns.
Detailed description
This study will take place in Uganda at Health Centers (level II, III and IV) and District Hospitals, to reach 'frontline' health providers who attend births. This study will take place in districts meeting study criteria in two regions to demonstrate ability to implement in different geographic settings and potential for scale up. It is a quasi-experimental design with three study arms/groups that receive different levels or intensities and modalities of the program intervention.
Briefly, the same simulator-based training will be provided in all three study arms. After the training, a simulator will be left in the health facility, and providers will be encouraged to practice with it regularly. In two of the study arms, specific health workers will be recruited to support the intervention by encouraging their colleagues to practice with the simulator. In one study arm, the practice will be further reinforced through mobile phone-based support. Following is a more detailed description of each of the three components.
Component 1 (Training): Training is composed of two separate training interventions. First, in each study facility, Ugandan master trainers (district trainers) will conduct a single day, simulator-driven training on PPH prevention and treatment; all providers who attend births will be invited to participate. Eight weeks later, in each facility, the same trainers will conduct a one-day, simulator-driven training for prevention and management of asphyxia in the newborn. After each one-day training, simulators will be left at the facility for practice with a corresponding practice schedule.
Component 2 (Peer-led Practice Sessions): On the day the first training (for PPH), 2 birth attendants at the facility will be selected to serve as clinical mentors (CM). The CMs will be trained to encourage their coworkers to participate in 15-minute practice sessions each week for 8 weeks, in which they will use the simulators to practice the skills learned in the one-day training. After the newborn asphyxia training occurs, these same CMs will be trained to support a similar practice schedule for the following 12 weeks - 8 weeks for newborn asphyxia practice and 4 weeks for combined PPH and asphyxia skills practice.
Component 3 (Mobile phone-based support): CMs will be connected to the district trainer via mobile phone for weekly phone calls during the practice periods to provide reminders and support for practice.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full - Train/oxy&miso/ B&M/Mentor/Phone | Experimental | Other: Helping Mothers Survive - Bleeding After Birth training, Other: Helping Babies Breathe, Behavioral: Mentor, Behavioral: Phone, Drug: oxytocin and misoprostol, Device: Newborn bag and maskHelping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor. |
| Partial - Train/oxy & miso/ B&M/Mentor | Experimental | Other: Helping Mothers Survive - Bleeding After Birth training, Other: Helping Babies Breathe, Behavioral: Mentor, Drug: oxytocin and misoprostol, Device: Newborn bag and maskHelping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice. |
| Comparison - Train/oxy & miso/ B&M | Active comparator | Other: Helping Mothers Survive - Bleeding After Birth training, Other: Helping Babies Breathe, Drug: oxytocin and misoprostol, Device: Newborn bag and maskHelping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- For Providers: Health providers who attend births in participating health facility and consent to be assessed at the time of enrollment and at several points in time over two years.
- For Clinical mentors: being an experienced skilled birth attendant and likely to remain at the facility during the study period
- For Women in Labor and Delivery and Newborns: Women in any stage of labor in participating facility who consent to observation of their delivery and care of their newborn (or consent from the next of kin if the woman is incapacitated and not able to provide consent)
- Facility In-charges and Stakeholders: Facility in-charges at sampled health facilities; stakeholders identified by Jhpiego senior managers as being influential in maternal and newborn health policy decisions in Uganda.
Key exclusion criteria (2 listed)
- Providers: has <1 year of experience, and has plans to be transferred to another facility or leave the facility soon
- Other types of participants: none
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 |
|---|---|---|
| Helping Mothers Survive - Bleeding After Birth trainingAlso: HMS BABOne-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage. | Other | Comparison - Train/oxy & miso/ B&M, Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor |
| Helping Babies BreatheAlso: HBBOne-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag \& mask device. | Other | Comparison - Train/oxy & miso/ B&M, Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor |
| MentorAlso: CMA birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day. | Behavioural | Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor |
| PhoneDistrict trainers telephone clinical mentors and encourage them to lead practice sessions. | Behavioural | Full - Train/oxy&miso/ B&M/Mentor/Phone |
| oxytocin and misoprostolAlso: oxy&misoThis study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up. | Drug | Comparison - Train/oxy & miso/ B&M, Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor |
| Newborn bag and maskAlso: B&MAll facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care | Device | Comparison - Train/oxy & miso/ B&M, Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor |
Primary outcome
Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage
Time frame: Baseline, Midline (6 months), Endline (12 months)
The change in the percentage of women who received oxytocin in correct dose immediately after vaginal birth in three study arms, as assessed by direct clinical observation, using a standardized checklist.
3 secondary outcomes
Change in provider performance on simulator-based assessments
Time frame: Pre-test (before training)- post-test (immediately after training) - midline (6 months)
Difference in differences: change in care of the mother composite score
Time frame: Baseline (before training), Midline (6 months), Endline (12 months)
Difference in differences: change care of the newborn composite score
Time frame: Baseline (before training), Midline (6 months), Endline (12 months)
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 22 Aug 2017.
- Derived from this study: PubMed 30925890Williams E, Bazant ES, Holcombe S, Atukunda I, Namugerwa RI, Britt K, Evans C. "Practice so that the skill does not disappear": mixed methods evaluation of simulator-based learning for midwives in Uganda. Hum Resour Health. 2019 Mar 29;17(1):24. doi: 10.1186/s12960-019-0350-z.
- Derived from this study: PubMed 30557350Evans CL, Bazant E, Atukunda I, Williams E, Niermeyer S, Hiner C, Zahn R, Namugerwa R, Mbonye A, Mohan D. Peer-assisted learning after onsite, low-dose, high-frequency training and practice on simulators to prevent and treat postpartum hemorrhage and neonatal asphyxia: A pragmatic trial in 12 districts in Uganda. PLoS One. 2018 Dec 17;13(12):e0207909. doi: 10.1371/journal.pone.0207909. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
Cherrie Evans, DrPH principal investigator
Jhpiego
Questions about this trial
What is this clinical trial studying?
A study testing Helping Mothers Survive - Bleeding After Birth training, Helping Babies Breathe and Mentor in people with Postpartum Hemorrhage and Neonatal Asphyxia, run by Jhpiego.
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 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage (time frame: Baseline, Midline (6 months), Endline (12 months)). 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 NCT03254628, which also lists 2 linked publications.
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 22 Aug 2017.