The prophylactic use of a Bakri balloon for women undergoing caesarean section for placenta praevia – a randomised controlled trial

Phase 4

Completed

• Conditions: pregnancy; placenta praevia; Reproductive Health and Childbirth - Childbirth and postnatal care; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12613000348752
• Lead Sponsor: Michael Beckmann

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

All women with live singleton pregnancies =24+0 weeks undergoing caesarean section in the setting of a known placenta praevia (leading edge of placenta <20mm from the cervical os) will be suitable for inclusion in this study

Exclusion Criteria

Multiple pregnancy
Intrauterine Fetal Death
Suspected placenta accreta
Congenital abnormalities of the uterine cavity
Submucosal uterine fibroids >5cm
Women who give birth vaginally
Women aged <18 years
Inability to consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinician’s decision to undertake further intervention to control bleeding (eg increased rate/duration/concentration of Syntocinon infusion, Misoprostol, Ergometrine, B-lynch or other compression suture, Ergometrine, PGF2 alpha, ligation of uterine/ovarian/internal iliac arteries, hysterectomy). The use of any additional measures will be determined following a review of the intraoperative documentation by the research midwife and this information will be recorded on a dedicated data collection form. [Within the first 24 hours after birth.];Change in haemoglobin, This will be assessed by the research midwife by reviewing the routine pre-operative and post-operative full blood examination results. The information will be recorded on a dedication data collection form[The haemoglobin measured as part of routine pre-operative bloods (performed between 1hour and 72 hours pre-op) will be compared with post-operative haemoglobin (performed between 14h and 24 hours post-op)]