Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa

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

Study Overview

• Status: Unknown
• Conditions: Placenta Previa
• Intervention / Treatment: Procedure: uterine artery ligation; Procedure: Lower segment Cesarean section

Detailed Description

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 In the control group, lower segment caesarean section is without uterine artery ligation

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Recruiting
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patients diagnosed with placenta praevia antenatally
• plan is elective caesarean section
• Gestational age >34 weeks

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: uterine artery ligation; 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.	Procedure: uterine artery ligation; 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; Procedure: Lower segment Cesarean section; 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
Active Comparator: Traditional lower segment Cesarean section; 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.	Procedure: Lower segment Cesarean section; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease in Hemoglabin level	24 hours after Cesarean

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa
• Other Study ID Numbers: 169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No