Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
1 other identifier
interventional
520
1 country
1
Brief Summary
the investigators aim to compare bimanual uterine compression immediately after delivery of the placenta for 5 minutes versus no intervention for the prevention of postpartum hemorrhage in Women at high risk for primary atonic postpartum hemorrhage. The primary outcome is postpartum haemorrhage (blood loss of ≥ 500 ml) while the Secondary outcomes include use of additional uterotonics and need for blood transfusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 11, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 10, 2020
March 1, 2020
6.7 years
May 11, 2014
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood loss 500 ml or more after enrolment
estimating blood loss from vagina
60 minutes after enrolment
Secondary Outcomes (3)
Blood loss 1000 ml or more after enrolment
(up to 30 and 60 minutes) after enrolment
Use of additional uterotonics or other procedures
60 minutes
Blood transfusion
60 minutes
Study Arms (2)
Group A
ACTIVE COMPARATORbimanual uterine compression immediately after delivery of placenta for 5 minutes in 260 women
Group B
NO INTERVENTIONno intervention (260 women).
Interventions
bimanual uterine compression immediately after delivery of placenta for 5 minutes
Eligibility Criteria
You may qualify if:
- Gestational age more than 28 weeks the gestational age was determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester
- Women at high risk for primary atonic postpartum hemorrhage
- Over distended uterus
- Large fetus
- Multiple fetuses
- Hydramnios
- Distension with clots accidental hemorrhage
- Exhausted myometrium
- Prolonged labor
- Oxytocin or prostaglandin stimulation
- Chorioamnionitis
- Previous uterine atony
- Placenta previa
- Marked anemia
You may not qualify if:
- Cervical tear
- extensive birth canal tear
- Postpartum hemorrhage
- Retained placenta
- Coagulopathy
- Chronic medical illness hepatic renal
- Pregnancy induced hypertension PIH
- Refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Benha univesity hospital and afhsa
Banhā, El Qualyobia, 13518, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ibrahim zweel
Department of Obstetrics and Gynecology,AFHSA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of ob/gyn
Study Record Dates
First Submitted
May 11, 2014
First Posted
May 13, 2014
Study Start
April 1, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
March 10, 2020
Record last verified: 2020-03