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

NCT ID: NCT03124472

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-06-30

Brief Summary

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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

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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

Conditions

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Placenta Previa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

uterine artery ligation

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Lower segment Cesarean section

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Maged, MD

Role: CONTACT

Phone: 01005227404

Email: [email protected]

Facility Contacts

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Ahmed Maged, MD

Role: primary

Other Identifiers

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169

Identifier Type: -

Identifier Source: org_study_id