Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa
1 other identifier
interventional
200
1 country
1
Brief Summary
Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.
- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
- Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
- Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
- Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
- Closure of the anterior abdominal wall in layers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
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
First Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJanuary 31, 2018
January 1, 2018
11 months
April 19, 2017
January 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease in Hemoglabin level
24 hours after Cesarean
Study Arms (2)
uterine artery ligation
ACTIVE COMPARATORPfannenstiel incision of skin and opening of the anterior abdominal wall in layers. * The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment. * Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged. * Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta.
Traditional lower segment Cesarean section
ACTIVE COMPARATORPfannenstiel incision of skin and opening of the anterior abdominal wall in layers. * The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment. * Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta.
Interventions
Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged
Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers. \- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment. Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta. * Closure of the uterine incision in 2 layers with N0. 1 vicryl suture. * Closure of the anterior abdominal wall in layers
Eligibility Criteria
You may qualify if:
- patients diagnosed with placenta praevia antenatally
- plan is elective caesarean section
- Gestational age \>34 weeks
You may not qualify if:
- Fetal distress
- medical disorders as hypertension or Diabetes Mellitus
- Coagulation defects.
- Emergency Cesarean section
- women with antepartum hemorrhage
- patients with marked ahdesions or those with non possible uterine artery ligation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alainy medical school
Cairo, 12151, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Maged, MD
Kasr Alainy medical school
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 19, 2017
First Posted
April 21, 2017
Study Start
June 1, 2017
Primary Completion
May 1, 2018
Study Completion
June 1, 2018
Last Updated
January 31, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share