Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section

Clinical Outcomes of Combined Bilateral Uterine Artery Ligation and Bakri Balloon Tamponade During Cesarean Section in Patients With Placenta Previa: a Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04518150

Enrollment

150

Registered

2020-08-19

Start date

2020-09-01

Completion date

2022-10-31

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Previa

Brief summary

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

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.

Interventions

DEVICEBakri 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

PROCEDUREBilateral 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Masking description

single blind randomized controlled trial

Intervention model description

A Randomized Controlled Trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
mean Blood loss after placental separation	30 minutes	by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

Secondary

Measure	Time frame	Description
The number of participant needed for blood transfusion	24 hours	Calculation of the number of participant needed for blood transfusion
Number of Participants with postpartum hemorrhage	24 hours	number pf participants with blood loss \> 1000ml

Countries

Egypt

Contacts

Primary Contacthany f Sallam, md

hany.farouk@aswu.edu.eg+20102435461

Backup Contactnahla w Shady, md

hanygyne@yahoo.com+201022336052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026