Placenta Previa
Conditions
Keywords
placenta previa, tranexamic acid, cesarean section, Foley's Catheter Balloon
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.
Interventions
PROCEDUREFoley's Catheter
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.
DRUGTA
patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline
DRUGPlacebo
patients received 100 ml saline just before skin incision
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
The study was a double-blind randomized controlled trial carried out in a tertiary University Hospital
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with postpartum hemorrhage | 24 hours post operative | number of participant with blood loss \> 1000ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | during the operation | amount of blood loss during cesarean section |
| The number of participant needed for blood transfusion | 24 hours postoperative | Calculation of the number of participant needed for blood transfusion |
| number of participant need of extra surgical maneuvers | 24 hours post operative | number of participant need of extra surgical maneuvers like internal iliac ligation or hysterectomy |
Countries
Egypt
Contacts
Primary Contacthany f sallam, md
Outcome results
None listed