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

Aswan University Hospital

Status: Unknown

Conditions: Placenta Previa

Treatments: Drug: Placebo; Procedure: Foley's Catheter; Drug: TA

Study type: Interventional

Funder types: Other

Identifiers

NCT03741114

aswu/199/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Foley's Catheter plus TA

Active Comparator group

Description:

patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus 1 gm tranexamic acid in 100ml saline intravenous just before skin incision

Treatment:

Drug: TA

Procedure: Foley's Catheter

Foley's Catheter plus placebo to TA

Active Comparator group

Description:

patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus single injection of 100 ml intravenous saline before skin incision

Treatment:

Procedure: Foley's Catheter

Drug: Placebo