Foley's Catheter Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

Placenta Previa Clinical Trial

Official title:

Intrauterine Inflated Foley's Catheter Balloon Plus Intravenous Tranexamic Acid During Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03741114
• Other study ID #: aswu/199/18
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: January 2019
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. Insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (PPH). The Bakri balloon has a sausage-like spindle shape and a drainage lumen and is made of silicon. It has been used in cases of uterine atony and placenta previa with a success rate of 90%. However, Bakri balloon is not available in all countries.

The aim of this study is to evaluate the efficacy of the use of intrauterine inflated Foley's catheter balloon with or without intravenous tranexamic acid to control PPH during cesarean delivery in cases of placenta previa.

Description:

Eligible participants were allocated to one of two groups. Group (I): patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus. Group (II): patients received 1 gm tranexamic acid (TA), (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus Intrauterine Inflated Foley's Catheter Balloon. In group I, patients received a single injection of intravenous saline before skin incision prepared in a syringe and coded by a pharmacist in the pharmacy of the hospital. Neither the surgeon nor the anesthetist will know the nature of the IV administered drug before cesarean section.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 1, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa

Exclusion Criteria:

• Patients with a cardiac, hepatic, renal or thromboembolic disease

• patients with the high possibility of the morbid adherent placenta

• known coagulopathy or thromboembolic disease

• those presented with severe antepartum hemorrhage

• hypersensitivity or contraindications of use of tranexamic acid

• patient refuses to consent

Related Conditions & MeSH terms

• Placenta Previa

Intervention

Procedure:
• Foley's Catheter
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.

Drug:
• TA
patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline
• Placebo
patients received 100 ml saline just before skin incision

Locations

Country	Name	City	State
Egypt	Aswan University	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	Number of Participants with postpartum hemorrhage	number of participant with blood loss > 1000ml	24 hours post operative
Secondary	intraoperative blood loss	amount of blood loss during cesarean section	during the operation
Secondary	The number of participant needed for blood transfusion	Calculation of the number of participant needed for blood transfusion	24 hours postoperative
Secondary	number of participant need of extra surgical maneuvers	number of participant need of extra surgical maneuvers like internal iliac ligation or hysterectomy	24 hours post operative