Fetal intrapartum pulse oximetry to reduce operative delivery rates in the presence of a non-reassuring fetal heart rate: a multicentre randomised controlled trial (the FOREMOST trial).

Phase 3

Completed

• Conditions: on-reassuring fetal status during labour; Non-reassuring fetal status during labour; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12606000307505
• Lead Sponsor: Royal Brisbane and Women's Hospital, The University of Queensland,Perinatal Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-03-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

Women in labour at > or = 36 weeks gestation with a non-reasuring CTG pattern.

Exclusion Criteria

Multiple gestation; non-vertex presentation; placenta praevia; abrnp? placenta; APH; fetal anomaly; known significant viral infection (eg HIV); contraindication to invasive fetal monitoring

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Operative delivery for non reassuring fetal status (NRFS)[Measured at the time of the birth of the baby]

Secondary Outcome Measures

Name	Time	Method
Staff perceptions of sensor placement.[Outcome measured soon after placing the oximetry sensor.];Operative delivery for other indications; fetal/neonatal variables (Apgar scores, umbilical and venous pH).[Outcomes measured at or close to the time of birth.];Admission to Neonatal Intensive Care Unit, (hypoxic-ixchaemic encephalopathy, death).[Outcomes measured within a few days of birth.];Maternal perceptions of their experience in the research project.[Outcome measured within a few days of giving birth and again three months later.]