NCT04518176

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

August 15, 2020

Last Update Submit

September 18, 2020

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • mean Blood loss after placental separation

    by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

    30 minutes

Secondary Outcomes (2)

  • Number of Participants with postpartum hemorrhage

    12 hours

  • The number of participant needed for blood transfusion

    24 hours

Study Arms (2)

study group

EXPERIMENTAL

patients with twin pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.

Procedure: bilateral uterine artery ligationDrug: Oxytocin

control group

ACTIVE COMPARATOR

patients with twin pregnancy undergoing cesarean section received oxytocin only.

Drug: Oxytocin

Interventions

bilateral uterine artery ligationPROCEDURE

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

Also known as: BUAL
study group
OxytocinDRUG

20 units by slow intravenous drip injection

control groupstudy group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women with twin pregnancy undergoing cesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women undergoing cesarean section
  • twin pregnancy

You may not qualify if:

  • Placenta previa.
  • Ante-partum hemorrhage.
  • patient refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • nahla w Shady, md

    Aswan universirty

    STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052hanygyne@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open label randomized controlled study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Professor

Study Record Dates

First Submitted

August 15, 2020

First Posted

August 19, 2020

Study Start

September 1, 2020

Primary Completion

June 30, 2022

Study Completion

August 31, 2022

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)