CompletedPhase 3ACTRN12606000307505

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).


Sponsor

Royal Brisbane and Women's Hospital, The University of Queensland,Perinatal Research Centre

Enrollment

600 participants

Start Date

Jul 1, 1999

Study Type

Interventional

Conditions

Summary

Current methods of monitoring the well-being of the unborn baby during labour often result in concern about the unborn baby's health. This leads to delivery by caesarean section, forceps, or vacuum. These babies are usually found to be healthy once born, meaning that the operation was unnecessary. In this study, when an unborn baby appears to be distressed, half of the study participants will be allocated to continue with the current monitoring of the baby's heartbeat. The other half will have a new form of monitoring, fetal oxygen saturation monitoring, added. We will then determine whether the new form of monitoring makes a difference int he number of times women need to have a caesarian section, forceps or vacuum delivery.


Eligibility

Sex: FemalesMin Age: 16 YearssMax Age: 44 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using a small sensor (pulse oximeter) on a baby during labour can help doctors make better decisions about delivery when the baby's heart rate looks concerning. It is for women aged 16-44 who are at least 36 weeks pregnant and in labour with a worrying heart rate pattern on the monitor.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Duration of Study: July 1999 to September 2004. Experimental group receive conventional CTG monitoring plus fetal oxygen saturation monitoring using an internal fetal sensor. Nellcor N-400/FS14 Moni

Duration of Study: July 1999 to September 2004. Experimental group receive conventional CTG monitoring plus fetal oxygen saturation monitoring using an internal fetal sensor. Nellcor N-400/FS14 Monitor Purpose: to determine whether the addition of fetal oximetry (oxygen values) to normal monitoring could help reduce the number of times caesarean sections, vacuum and forceps births were performed for concern about the well-being of the baby during labour.


Locations(1)

Australia

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ACTRN12606000307505