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

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Placenta Previa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was a double-blind randomized controlled trial carried out in a tertiary University Hospital

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used.

Study Groups

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Foley's Catheter plus TA

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

Group Type ACTIVE_COMPARATOR

Foley's Catheter

Intervention Type PROCEDURE

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

TA

Intervention Type DRUG

patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline

Foley's Catheter plus placebo to TA

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

Group Type ACTIVE_COMPARATOR

Foley's Catheter

Intervention Type PROCEDURE

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

Placebo

Intervention Type DRUG

patients received 100 ml saline just before skin incision

Interventions

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Foley's Catheter

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

Intervention Type PROCEDURE

TA

patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline

Intervention Type DRUG

Placebo

patients received 100 ml saline just before skin incision

Intervention Type DRUG

Other Intervention Names

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Active Comparator active comparator Placebo to TA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No