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Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section

Primary Purpose

Post Partum Hemorrhage

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Oxytocin

bilateral uterine artery ligation

About this trial

This is an interventional treatment trial for Post Partum Hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women with one or more of the following conditions undergoing cesarean section for obstetric indication were included:
Maternal anemia (not less than 7 gm %).
Macrosomic baby >4kgs.
Twin pregnancy and high order pregnancy.
Polyhydramnios.
Grand multipara.
Previous history of atonic postpartum hemorrhage.
Prolonged vaginal delivery.
Emergency cesarean.
Chorioamnionitis.

Exclusion Criteria:

- Placenta previa.
Patients with bleeding tendency (congenital or acquired)
Ante-partum hemorrhage.
Patients with no risk for uterine atony.

Sites / Locations

Ahmed Abbas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group

control group

Arm Description

patients at risk of uterine atony undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.

patients at risk of uterine atony undergoing cesarean section received oxytocin only.

Outcomes

Primary Outcome Measures

mean Blood loss after placental separation

by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

Secondary Outcome Measures

Full Information

NCT ID

NCT03591679

First Posted

July 8, 2018

Last Updated

March 8, 2019

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03591679

Brief Title

Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section

Official Title

Role of Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section in Patients At Risk of Uterine Atony A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

November 30, 2018 (Actual)

Study Completion Date

January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The patients were recruited from women attending labor ward to undergo cesarean section.

6. Conditions and Keywords

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

Post Partum Hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1070 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Experimental

Arm Description

patients at risk of uterine atony undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.

Arm Title

control group

Arm Type

Active Comparator

Arm Description

patients at risk of uterine atony undergoing cesarean section received oxytocin only.

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Intervention Description

20 units by slow intravenous drip injection

Intervention Type

Procedure

Intervention Name(s)

bilateral uterine artery ligation

Intervention Description

• The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.

Primary Outcome Measure Information:

Title

mean Blood loss after placental separation

Description

by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

Time Frame

30 minutes

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women with one or more of the following conditions undergoing cesarean section for obstetric indication were included: Maternal anemia (not less than 7 gm %). Macrosomic baby >4kgs. Twin pregnancy and high order pregnancy. Polyhydramnios. Grand multipara. Previous history of atonic postpartum hemorrhage. Prolonged vaginal delivery. Emergency cesarean. Chorioamnionitis. Exclusion Criteria: - Placenta previa. Patients with bleeding tendency (congenital or acquired) Ante-partum hemorrhage. Patients with no risk for uterine atony.

Facility Information:

Facility Name

Ahmed Abbas

City

Assiut

State/Province

Cairo

ZIP/Postal Code

002

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

31755559

Citation

Samy A, Ali MK, Abbas AM, Wahab HA, Wali AA, Hussien AH, Mostafa M, Taymour MA, Ogila AI, Ahmad Y, Essam A, Mahmoud M. Randomized controlled trial of the effect of bilateral uterine artery ligation during cesarean among women at risk of uterine atony. Int J Gynaecol Obstet. 2020 Feb;148(2):219-224. doi: 10.1002/ijgo.13064. Epub 2019 Dec 10.

Results Reference

derived

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Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section

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