Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section

NCT ID: NCT04518150

Last Updated: 2020-09-21

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-10-31

Brief Summary

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This study will be performed to compare the effectiveness of routine Bakri balloon tamponade and Bilateral Uterine Artery Ligation during cesarean section in patients with placenta previa

Detailed Description

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Intraoperative methods to control profuse bleeding during cesarean section in patients with placenta previa include uterine packing, balloon tamponade, uterine compression sutures, arterial ligation, uterine artery embolization, and hysterectomy.

Conditions

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Placenta Previa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Randomized Controlled Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
single blind randomized controlled trial

Study Groups

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study group

patients with placenta previa undergoing cesarean section underwent bilateral uterine artery ligation plus insertion of Bakri balloon

Group Type EXPERIMENTAL

Bakri balloon

Intervention Type DEVICE

the Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally

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 with placenta previa undergoing cesarean section underwent insertion of Bakri balloon

Group Type ACTIVE_COMPARATOR

Bakri balloon

Intervention Type DEVICE

the Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally

Interventions

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Bakri balloon

the Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally

Intervention Type DEVICE

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

Other Intervention Names

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BBT BUAL

Eligibility Criteria

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Inclusion Criteria

* women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Exclusion Criteria

* patients with the high possibility of morbid adherent placenta
* those presented with severe antepartum hemorrhage
* Patients with cardiac, hepatic, renal, or thromboembolic disease;
* patient refuses to consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

A Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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hany f Sallam, md

Role: CONTACT

+20102435461 ext. 002

nahla w Shady, md

Role: CONTACT

+201022336052 ext. 002

Facility Contacts

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Hany F Sallam, MD

Role: primary

0122336052 ext. 002

Nahla W Shady, MD

Role: backup

01092440504 ext. 002

Other Identifiers

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aswu/270/9/18

Identifier Type: -

Identifier Source: org_study_id

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