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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04518150
Other study ID # aswu/270/9/18
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date October 31, 2022

Study information

Verified date September 2020
Source Aswan University Hospital
Contact hany f Sallam, md
Phone +20102435461
Email hany.farouk@aswu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date October 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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
Procedure:
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.

Locations

Country Name City State
Egypt Aswan University Hospital Aswan

Sponsors (1)

Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 30 minutes
Secondary The number of participant needed for blood transfusion Calculation of the number of participant needed for blood transfusion 24 hours
Secondary Number of Participants with postpartum hemorrhage number pf participants with blood loss > 1000ml 24 hours
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Completed NCT03542552 - Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa Phase 3
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Recruiting NCT03633175 - Progesterone in Patients With Placenta Previa Phase 2
Not yet recruiting NCT03208842 - Relation of Implantation Site to Placental Site in Presence or Absence of Cesarean Section Scar N/A