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

Placenta Previa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03124472
• Other study ID #: 169
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2017
• Last updated: January 30, 2018
• Start date: June 1, 2017
• Est. completion date: June 2018

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: 01005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Previa

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Hemoglabin level		24 hours after Cesarean