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

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



Sponsors

Lead Sponsor



Source

Cairo University

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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

Overall Status

Not yet recruiting

Start Date

2017-04-01

Completion Date

2018-01-01

Primary Completion Date

2017-12-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Decrease in Hemoglabin level
24 hours after Cesarean

Enrollment

200

Condition


Intervention

Intervention Type

Procedure

Intervention Name


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

Arm Group Label

uterine artery ligation


Intervention Type

Procedure

Intervention Name


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

Arm Group Label

uterine artery ligation

Traditional lower segment Cesarean section




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

Gender

Female

Gender Based

Yes

Minimum Age

19 Years

Maximum Age

40 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Ahmed Maged, MD
Principal Investigator
Kasr Alainy medical school

Overall Contact

Last Name

Ahmed Maged, MD

Phone

01005227404

Email

[email protected]


Location

Facility

Kasr Alainy medical school
Cairo 12151 Egypt

Location Countries

Country

Egypt


Verification Date

2017-04-01

Lastchanged Date

2017-04-19

Firstreceived Date

2017-04-19

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Cairo University

Investigator Full Name

Ahmed Maged

Investigator Title

Professor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

uterine artery ligation

Arm Group Type

Active Comparator

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 Group Label

Traditional lower segment Cesarean section

Arm Group Type

Active Comparator

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.



Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

Yes


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Prevention

Masking

No masking



ClinicalTrials.gov processed this data on April 21, 2017

Conditions

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Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

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In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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