Clinical trial NCT03741114: Foley's Catheter Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Previa
Keywords: placenta previa
tranexamic acid
cesarean section
Foley's Catheter Balloon
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a double-blind randomized controlled trial carried out in a tertiary University Hospital
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with postpartum hemorrhage
timeFrame: 24 hours post operative
Secondary outcomes:
measure: intraoperative blood loss
timeFrame: during the operation
measure: The number of participant needed for blood transfusion
timeFrame: 24 hours postoperative
measure: number of participant need of extra surgical maneuvers
timeFrame: 24 hours post operative
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References: