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

Primary Purpose

Placenta Previa

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
uterine artery ligation
Lower segment Cesarean section
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kasr Alainy medical schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

uterine artery ligation

Traditional lower segment Cesarean section

Arm 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.

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.

Outcomes

Primary Outcome Measures

Decrease in Hemoglabin level

Secondary Outcome Measures

Full Information

First Posted
April 19, 2017
Last Updated
January 30, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03124472
Brief Title
Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa
Official Title
Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
uterine artery ligation
Arm Type
Active Comparator
Arm 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.
Arm Title
Traditional lower segment Cesarean section
Arm Type
Active Comparator
Arm 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. 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.
Intervention Type
Procedure
Intervention Name(s)
uterine artery ligation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Lower segment Cesarean section
Intervention 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. 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
Primary Outcome Measure Information:
Title
Decrease in Hemoglabin level
Time Frame
24 hours after Cesarean

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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