Introduction of UBT for PPH Management in Three Countries
NCT ID: NCT02910310
Last Updated: 2018-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60105 participants
INTERVENTIONAL
2016-10-31
2018-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Baseline period
The baseline period will involve data collection on study outcomes before uterine balloon tamponade (UBT) is introduced at study sites.
No interventions assigned to this group
Uterine balloon tamponade
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.
Uterine balloon tamponade
An intervention consisting of inserting a condom attached to a urinary catheter into the uterus and inflating it with fluid to stop postpartum bleeding
Interventions
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Uterine balloon tamponade
An intervention consisting of inserting a condom attached to a urinary catheter into the uterus and inflating it with fluid to stop postpartum bleeding
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
FEMALE
Yes
Sponsors
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Ministry of Health and Population, Egypt
OTHER_GOV
Alexandria University
OTHER
El Galaa Teaching Hospital
OTHER
Global Health Uganda LTD
OTHER
Makerere University
OTHER
Ministry of Health, Uganda
OTHER_GOV
Ministere de la Sante et des Services Sociaux
OTHER
Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Holly Anger, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Rasha Dabash, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Laura Frye, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Ayisha Diop, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Sam Ononge, MD
Role: PRINCIPAL_INVESTIGATOR
Makerere University
Nevine Hassanien, MD
Role: PRINCIPAL_INVESTIGATOR
Consultant
Mohamed Cherine Ramadan, MD
Role: PRINCIPAL_INVESTIGATOR
El Galaa Teaching Hospital
Emad Darwish, MD
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Bocar Daff, MD
Role: PRINCIPAL_INVESTIGATOR
Ministry of Health, Senegal
Beverly Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Locations
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Abu Hummus Hospital
Abū Ḩummuş, , Egypt
Fayoum General Hospital
Al Fayyum, , Egypt
Ismailia General Hospital
Ismailia, , Egypt
Itsa Hospital
Iţsā, , Egypt
Etay el Barood Hospital
Ītāy al Bārūd, , Egypt
Kafr el Dawar Hospital
Kafr El Dawar, , Egypt
Centre de Santé Gaspard Camara
Dakar, , Senegal
Centre de Santé Nabil Choucair
Dakar, , Senegal
Centre de Santé Philip Maguilene Senghor
Dakar, , Senegal
Hôpital Roi Boudoin
Dakar, , Senegal
Centre de Santé Tefess Mbour
Mbour, , Senegal
Hôpital Régional de Mbour
Mbour, , Senegal
Gombe Hospital
Gombe, , Uganda
Itojo Hospital
Itojo, , Uganda
Kiryandongo Hospital
Kiryandongo, , Uganda
Kitagata Hospital
Kitagata, , Uganda
Lyantonde Hospital
Lyantonde, , Uganda
Masindi Hospital
Masindi, , Uganda
Countries
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References
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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.
Other Identifiers
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3005
Identifier Type: -
Identifier Source: org_study_id
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