Postpartum HemorrhageUBTNCT02910310
Introduction of UBT for PPH Management in Three Countries
A study testing Uterine balloon tamponade in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 18 sites in 3 countries.
Trial summary
This study is a prospective, systematic evaluation to assess the effectiveness and safety of introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource countries. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Uterine balloon tamponade
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,105 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Oct 2016to Mar 2018
- 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
- Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere
- Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere
- Diagnosed and treated for PPH during the stepped wedge trial
- Willing and able to give informed consent
- Agree to participate in a postpartum interview before hospital discharge
- Agree to brief follow-up interview 4 weeks after delivery
Who cannot join
- Delivery via Cesarean section
- Transferred to another facility before delivery
- Transferred to the participating facility after vaginal delivery elsewhere but died before arrival
- Eligibility for nested cohort analysis:
- Delivery via Cesarean section
- Transferred to another facility before delivery
- Transferred to the participating facility after vaginal delivery elsewhere but died before arrival
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Egypt6 sites
Abu Hummus Hospital
Abū Ḩummuş
Fayoum General Hospital
Al Fayyum
Ismailia General Hospital
Ismailia
Etay el Barood Hospital
Ītāy al Bārūd
Itsa Hospital
Iţsā
Kafr el Dawar Hospital
Kafr El Dawar
Senegal6 sites
Centre de Santé Gaspard Camara
Dakar
Centre de Santé Nabil Choucair
Dakar
Centre de Santé Philip Maguilene Senghor
Dakar
Hôpital Roi Boudoin
Dakar
Centre de Santé Tefess Mbour
Mbour
Hôpital Régional de Mbour
Mbour
Uganda6 sites
Gombe Hospital
Gombe
Itojo Hospital
Itojo
Kiryandongo Hospital
Kiryandongo
Kitagata Hospital
Kitagata
Lyantonde Hospital
Lyantonde
Masindi Hospital
Masindi
About this study
Official title: Introduction of a Uterine Balloon Tamponade for Postpartum Hemorrhage in Three Low Income Countries: a Stepped Wedge Cluster Randomized Trial
This study is a prospective, systematic evaluation to assess the effectiveness and safety of introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource countries. The first component of the evaluation is a prospective stepped wedge cluster randomized design to assess the potential reduction in PPH-related mortality and invasive procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial embolization) for PPH performed at participating facilities following introduction of UBT. The second component is a nested cohort analysis to assess the safety and acceptability of UBT among women diagnosed with PPH.
Read the detailed description
To assess the effectiveness of introduction of the UBT, a stepped wedge cluster randomized design will be employed to monitor maternal health outcomes among vaginal deliveries occurring at all participating facilities during the study phases described below:
Baseline phase: A baseline phase will be conducted in all participating sites before training and introduction of the UBT for PPH management. This phase will consist of prospective data collection to establish the baseline rates of key study outcomes.
Step 1 intervention phase: In this phase, participating sites will be randomized such that half will receive training on use of the UBT for PPH management with subsequent introduction into their standard practice and half will continue data collection without UBT introduction.
Step 2 intervention phase: In this phase, the remaining sites will receive training on use of the UBT for PPH management with subsequent introduction into their standard practice. During this phase, all participating sites will continue data collection to document study outcomes and all will be using UBT in their standard practice.
To assess the safety and acceptability of the use of UBT for PPH management, a nested cohort analysis will be done among women diagnosed with PPH during the stepped wedge trial. The investigators will assess the rates of treatment of postpartum infection and examine acceptability of care provided among the following two cohorts of women:
UBT group: All women diagnosed with PPH following a vaginal delivery and who have an attempted UBT placement (including successful or unsuccessful placements).
No-UBT group: All women diagnosed with PPH following a vaginal delivery that do not have an attempted UBT placement.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Uterine balloon tamponade
- Keywords
- Uterine Balloon Tamponade
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine balloon tamponadeOther
An intervention consisting of inserting a condom attached to a urinary catheter into the uterus and inflating it with fluid to stop postpartum bleeding
| Study group | Role | What they receive |
|---|---|---|
| Baseline period | No intervention | The baseline period will involve data collection on study outcomes before uterine balloon tamponade (UBT) is introduced at study sites. |
| Uterine balloon tamponade | Experimental | The UBT period will involve data collection on study outcomes after providers at sites are trained on UBT use and UBT is introduced into PPH management practice at study sites. Receives: Other: Uterine balloon tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal death due to PPH or invasive procedures due to PPH
Proportion of women who experience maternal death due to PPH or who receive invasive procedures (including compression/B Lynch sutures, uterine artery ligation, uterine artery embolization, and hysterectomy) for PPH management. This is the primary outcome for the stepped wedge trial.
Measured: After delivery and before discharge from facility (usually within 48 hours after delivery)
Treatment of postpartum infection among women diagnosed with PPH
Proportion of women diagnosed with PPH who receive antibiotics for presumptive or confirmed postpartum infection after hospital discharge and within 4 weeks postpartum. This is the primary outcome for the nested cohort analysis.
Measured: Within 4 weeks after delivery
Secondary outcomes (4)
Proportion of women who receive blood transfusion for PPH management
Proportion of women who receive blood transfusion for PPH management. This outcome will be assessed for the stepped wedge trial.
Measured: After delivery and before discharge from facility (usually within 48 hours after delivery)
Transfer to next level care
Proportion of women transferred to the next level referral facility due to PPH. This outcome will be assessed for the stepped wedge trial.
Measured: After delivery and before discharge from facility (usually within 48 hours after delivery)
Treatment for severe postpartum infection
Proportion of women diagnosed with PPH who are hospitalized due to postpartum infection and/or receive intravenous antibiotics to treat postpartum infection after hospital discharge and within 4 weeks postpartum. This outcome will be assessed in the nested cohort analysis.
Measured: Within 4 weeks after delivery
Level of pain experienced by women postpartum
Level of pain experienced after delivery as reported by women diagnosed with PPH. Pain will be assessed using a 10-point scale. This outcome will be assessed in the nested cohort analysis.
Measured: After delivery and before discharge from facility (usually within 48 hours after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionMar 2018
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt, Alexandria University, El Galaa Teaching Hospital, Global Health Uganda LTD, Makerere University, Ministry of Health, Uganda, Ministere de la Sante et des Services Sociaux
- Responsible party
- Sponsor
- Investigators
- Holly Anger, MPH, Principal investigator, Gynuity Health ProjectsRasha Dabash, MPH, Principal investigator, Gynuity Health ProjectsLaura Frye, MPH, Principal investigator, Gynuity Health ProjectsAyisha Diop, MPH, Principal investigator, Gynuity Health ProjectsSam Ononge, MD, Principal investigator, Makerere UniversityNevine Hassanien, MD, Principal investigator, ConsultantMohamed Cherine Ramadan, MD, Principal investigator, El Galaa Teaching HospitalEmad Darwish, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910310
- Sponsor's protocol ID
- 3005
- Acronym
- UBT
- Status last verified
- Jul 2018
- First submitted
- 15 Sep 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
PubMed 32609374
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of a Uterine Balloon Tamponade for Postpartum Hemorrhage in Three Low Income Countries: a Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02910310
- Acronym / sponsor ID
- UBT / 3005
- Conditions
- Postpartum Hemorrhage
- Keywords
- Uterine Balloon Tamponade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60,105 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt, Alexandria University, El Galaa Teaching Hospital, Global Health Uganda LTD, Makerere University, Ministry of Health, Uganda, Ministere de la Sante et des Services Sociaux
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 22 Sep 2016 (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.
This study is a prospective, systematic evaluation to assess the effectiveness and safety of introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource countries. The first component of the evaluation is a prospective stepped wedge cluster randomized design to assess the potential reduction in PPH-related mortality and invasive procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial embolization) for PPH performed at participating facilities following introduction of UBT. The second component is a nested cohort analysis to assess the safety and acceptability of UBT among women diagnosed with PPH.
Detailed description
To assess the effectiveness of introduction of the UBT, a stepped wedge cluster randomized design will be employed to monitor maternal health outcomes among vaginal deliveries occurring at all participating facilities during the study phases described below:
Baseline phase: A baseline phase will be conducted in all participating sites before training and introduction of the UBT for PPH management. This phase will consist of prospective data collection to establish the baseline rates of key study outcomes.
Step 1 intervention phase: In this phase, participating sites will be randomized such that half will receive training on use of the UBT for PPH management with subsequent introduction into their standard practice and half will continue data collection without UBT introduction.
Step 2 intervention phase: In this phase, the remaining sites will receive training on use of the UBT for PPH management with subsequent introduction into their standard practice. During this phase, all participating sites will continue data collection to document study outcomes and all will be using UBT in their standard practice.
To assess the safety and acceptability of the use of UBT for PPH management, a nested cohort analysis will be done among women diagnosed with PPH during the stepped wedge trial. The investigators will assess the rates of treatment of postpartum infection and examine acceptability of care provided among the following two cohorts of women:
UBT group: All women diagnosed with PPH following a vaginal delivery and who have an attempted UBT placement (including successful or unsuccessful placements).
No-UBT group: All women diagnosed with PPH following a vaginal delivery that do not have an attempted UBT placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline period | No intervention | –The baseline period will involve data collection on study outcomes before uterine balloon tamponade (UBT) is introduced at study sites. |
| Uterine balloon tamponade | Experimental | Other: Uterine balloon tamponadeThe UBT period will involve data collection on study outcomes after providers at sites are trained on UBT use and UBT is introduced into PPH management practice at study sites. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere
- Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere
- Diagnosed and treated for PPH during the stepped wedge trial
- Willing and able to give informed consent
- Agree to participate in a postpartum interview before hospital discharge
Key exclusion criteria (7 listed)
- Delivery via Cesarean section
- Transferred to another facility before delivery
- Transferred to the participating facility after vaginal delivery elsewhere but died before arrival
- Delivery via Cesarean section
- Transferred to another facility before delivery
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 |
|---|---|---|
| Uterine balloon tamponadeAn intervention consisting of inserting a condom attached to a urinary catheter into the uterus and inflating it with fluid to stop postpartum bleeding | Other | Uterine balloon tamponade |
Primary outcome
Maternal death due to PPH or invasive procedures due to PPH
Time frame: After delivery and before discharge from facility (usually within 48 hours after delivery)
Proportion of women who experience maternal death due to PPH or who receive invasive procedures (including compression/B Lynch sutures, uterine artery ligation, uterine artery embolization, and hysterectomy) for PPH management. This is the primary outcome for the stepped wedge trial.
Treatment of postpartum infection among women diagnosed with PPH
Time frame: Within 4 weeks after delivery
Proportion of women diagnosed with PPH who receive antibiotics for presumptive or confirmed postpartum infection after hospital discharge and within 4 weeks postpartum. This is the primary outcome for the nested cohort analysis.
4 secondary outcomes
Proportion of women who receive blood transfusion for PPH management
Time frame: After delivery and before discharge from facility (usually within 48 hours after delivery)
Transfer to next level care
Time frame: After delivery and before discharge from facility (usually within 48 hours after delivery)
Treatment for severe postpartum infection
Time frame: Within 4 weeks after delivery
Level of pain experienced by women postpartum
Time frame: After delivery and before discharge from facility (usually within 48 hours after delivery)
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 26 Jul 2018.
- Derived from this study: PubMed 32609374Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
Related trials for Postpartum Hemorrhage
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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.
Holly Anger, MPH principal investigator
Gynuity Health Projects
Rasha Dabash, MPH principal investigator
Gynuity Health Projects
Laura Frye, MPH principal investigator
Gynuity Health Projects
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine balloon tamponade in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 18 sites in 3 countries.
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 6 inclusion and 7 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Egypt, Senegal, Uganda. 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?
Maternal death due to PPH or invasive procedures due to PPH (time frame: After delivery and before discharge from facility (usually within 48 hours after delivery)). The study lists 2 primary outcomes in all. 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 NCT02910310, 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 26 Jul 2018.