Clinical trial NCT02910310: Introduction of UBT for PPH Management in Three Countries
Official title: Introduction of a Uterine Balloon Tamponade for Postpartum Hemorrhage in Three Low Income Countries: a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Uterine Balloon Tamponade
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Population, Egypt
name: Alexandria University
name: El Galaa Teaching Hospital
name: Global Health Uganda LTD
name: Makerere University
name: Ministry of Health, Uganda
name: Ministere de la Sante et des Services Sociaux
First posted: 2016-09-22
Enrollment: 60105
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Eligibility for stepped wedge trial:

Inclusion Criteria:

* Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere

Exclusion Criteria:

* 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:

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

* Delivery via Cesarean section
* Transferred to another facility before delivery
* Transferred to the participating facility after vaginal delivery elsewhere but died before arrival

Primary outcomes:
measure: Maternal death due to PPH or invasive procedures due to PPH
timeFrame: After delivery and before discharge from facility (usually within 48 hours after delivery)
measure: Treatment of postpartum infection among women diagnosed with PPH
timeFrame: Within 4 weeks after delivery
Secondary outcomes:
measure: Proportion of women who receive blood transfusion for PPH management
timeFrame: After delivery and before discharge from facility (usually within 48 hours after delivery)
measure: Transfer to next level care
timeFrame: After delivery and before discharge from facility (usually within 48 hours after delivery)
measure: Treatment for severe postpartum infection
timeFrame: Within 4 weeks after delivery
measure: Level of pain experienced by women postpartum
timeFrame: After delivery and before discharge from facility (usually within 48 hours after delivery)
Other outcomes:
Locations:
city: Abu Hummus
country: Egypt
facility: Abu Hummus Hospital
city: Fayoum
country: Egypt
facility: Fayoum General Hospital
city: Ismailia
country: Egypt
facility: Ismailia General Hospital
city: Itay al Barud
country: Egypt
facility: Etay el Barood Hospital
city: Itsa
country: Egypt
facility: Itsa Hospital
city: Kafr El Dawar
country: Egypt
facility: Kafr el Dawar Hospital
city: Dakar
country: Senegal
facility: Centre de Santé Gaspard Camara
city: Dakar
country: Senegal
facility: Centre de Santé Nabil Choucair
city: Dakar
country: Senegal
facility: Centre de Santé Philip Maguilene Senghor
city: Dakar
country: Senegal
facility: Hôpital Roi Boudoin
city: Mbour
country: Senegal
facility: Centre de Santé Tefess Mbour
city: Mbour
country: Senegal
facility: Hôpital Régional de Mbour
city: Gombe
country: Uganda
facility: Gombe Hospital
city: Itojo
country: Uganda
facility: Itojo Hospital
city: Kiryandongo
country: Uganda
facility: Kiryandongo Hospital
city: Kitagata
country: Uganda
facility: Kitagata Hospital
city: Lyantonde
country: Uganda
facility: Lyantonde Hospital
city: Masindi
country: Uganda
facility: Masindi Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Holly Anger, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Rasha Dabash, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Laura Frye, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Ayisha Diop, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Sam Ononge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant
name: Nevine Hassanien, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: El Galaa Teaching Hospital
name: Mohamed Cherine Ramadan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Emad Darwish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, Senegal
name: Bocar Daff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.