- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518176
Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins
September 18, 2020 updated by: hany farouk, Aswan University Hospital
Clinical Outcomes of Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins: A Randomized Controlled Trial
Objective to assess the effectiveness of prophylactic bilateral uterine artery ligation (BUAL) in reducing the incidence of postpartum hemorrhage during cesarean delivery among women with twin pregnancy
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
A randomized clinical trial at Aswan University Maternity Hospital, Egypt.
Women with twin pregnancy undergoing scheduled or emergency cesarean were randomized into two groups.
In the BUAL group, women underwent BUAL before placental delivery; in the control group, women had cesarean delivery without BUAL.
The primary outcome was the estimated blood loss during a cesarean
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aswan, Egypt, 81528
- Recruiting
- Aswan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women undergoing cesarean section
- twin pregnancy
Exclusion Criteria:
- Placenta previa.
- Ante-partum hemorrhage.
- patient refuse to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
patients with twin pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.
|
20 units by slow intravenous drip injection
The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally
Other Names:
|
Active Comparator: control group
patients with twin pregnancy undergoing cesarean section received oxytocin only.
|
20 units by slow intravenous drip injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean Blood loss after placental separation
Time Frame: 30 minutes
|
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with postpartum hemorrhage
Time Frame: 12 hours
|
number pf participants with blood loss > 1000ml
|
12 hours
|
The number of participant needed for blood transfusion
Time Frame: 24 hours
|
Calculation of the number of participant needed for blood transfusion
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
August 31, 2022
Study Registration Dates
First Submitted
August 15, 2020
First Submitted That Met QC Criteria
August 15, 2020
First Posted (Actual)
August 19, 2020
Study Record Updates
Last Update Posted (Actual)
September 21, 2020
Last Update Submitted That Met QC Criteria
September 18, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- aswu/279/8/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cesarean Section Complications
-
Assiut UniversityNot yet recruitingCesarean Section Complications | Cesarean Section Niche
-
Recep Tayyip Erdogan University Training and Research...CompletedCesarean Section Complications | Cesarean Section; DehiscenceTurkey
-
Ataturk UniversityUnknownCesarean Section Complications | Cesarean Section; Complications, Wound, Dehiscence | Cesarean Section, Repeated | Cesarean, Uterine Scar Thickness | Cesarean, Residual Myometrial ThicknessTurkey
-
University of CalgaryNot yet recruitingCesarean Section ComplicationsCanada
-
Peking University People's HospitalNot yet recruiting
-
Aswan University HospitalCompletedCesarean Section ComplicationsEgypt
-
Gaziosmanpasa Research and Education HospitalUnknownCesarean Section ComplicationsTurkey
-
Ain Shams UniversityUnknownCesarean Section ComplicationsEgypt
-
Mohamed Abdelrady MohamedCompletedCesarean Section ComplicationsEgypt
-
McGill University Health Centre/Research Institute...Thammasat UniversityUnknownCesarean Section ComplicationsCanada
Clinical Trials on Oxytocin
-
Hillel Yaffe Medical CenterUnknownCervix; Insufficient Dilatation in LaborIsrael
-
University of NebraskaNational Institute of Mental Health (NIMH)Terminated
-
University of Electronic Science and Technology...Completed
-
GlaxoSmithKlineCompletedPostpartum HemorrhageUnited Kingdom
-
University of Electronic Science and Technology...Recruiting
-
GlaxoSmithKlineMonash University; InVentiv CliniqueTerminatedPostpartum HemorrhageAustralia, United Kingdom
-
University Hospital, ToulouseCompleted
-
OptiNose ASUniversity of OsloCompletedHealthy Male AdultsNorway
-
Washington University School of MedicineUniversity of MichiganRecruiting
-
University of NebraskaNot yet recruiting