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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02910310
Date of registration:	15/09/2016
Prospective Registration:	Yes
Primary sponsor:	Gynuity Health Projects
Public title:	Introduction of UBT for PPH Management in Three Countries UBT
Scientific title:	Introduction of a Uterine Balloon Tamponade for Postpartum Hemorrhage in Three Low Income Countries: a Stepped Wedge Cluster Randomized Trial
Date of first enrolment:	October 2016
Target sample size:	60105
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02910310
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Egypt	Senegal	Uganda

Contacts

Name:	Ayisha Diop, MPH
Address:
Telephone:
Email:
Affiliation:	Gynuity Health Projects

Name:	Bocar Daff, MD
Address:
Telephone:
Email:
Affiliation:	Ministry of Health, Senegal

Name:	Mohamed Cherine Ramadan, MD
Address:
Telephone:
Email:
Affiliation:	El Galaa Teaching Hospital

Name:	Rasha Dabash, MPH
Address:
Telephone:
Email:
Affiliation:	Gynuity Health Projects

Name:	Emad Darwish, MD
Address:
Telephone:
Email:
Affiliation:	Alexandria University

Name:	Sam Ononge, MD
Address:
Telephone:
Email:
Affiliation:	Makerere University

Name:	Nevine Hassanien, MD
Address:
Telephone:
Email:
Affiliation:	Consultant

Name:	Beverly Winikoff, MD, MPH
Address:
Telephone:
Email:
Affiliation:	Gynuity Health Projects

Name:	Holly Anger, MPH
Address:
Telephone:
Email:
Affiliation:	Gynuity Health Projects

Name:	Laura Frye, MPH
Address:
Telephone:
Email:
Affiliation:	Gynuity Health Projects

Key inclusion & exclusion 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

Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Postpartum Hemorrhage

Intervention(s)

Other: Uterine balloon tamponade

Primary Outcome(s)

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)]

Treatment of postpartum infection among women diagnosed with PPH [Time Frame: Within 4 weeks after delivery]

Secondary Outcome(s)

Transfer to next level care [Time Frame: After delivery and before discharge from facility (usually within 48 hours after delivery)]

Level of pain experienced by women postpartum [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]

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)]

Secondary ID(s)

3005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Health and Population, Egypt

Global Health Uganda LTD

Ministere de la Sante et des Services Sociaux

Makerere University

El Galaa Teaching Hospital

Alexandria University

Ministry of Health, Uganda

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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