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

NCT ID: NCT03591679

Last Updated: 2019-03-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

1070 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-01-01

Brief Summary

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

Detailed Description

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Conditions

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Post Partum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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study group

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

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

20 units by slow intravenous drip injection

bilateral uterine artery ligation

Intervention Type PROCEDURE

• 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.

control group

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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

20 units by slow intravenous drip injection

Interventions

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Oxytocin

20 units by slow intravenous drip injection

Intervention Type DRUG

bilateral uterine artery ligation

• 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 31755559 (View on PubMed)

Other Identifiers

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BUALCS

Identifier Type: -

Identifier Source: org_study_id

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