RecruitingACTRN12615001308583

A randomised controlled trial of pregnant women being monitored during labour with ST analysis monitoring and cardiotocography, compared to being monitored with cardiotocography alone, in order to reduce caesarean section whilst still having comparable outcomes for the baby.

In pregnant women with a singleton pregnancy at greater than 36 weeks gestation, having intrapartum monitoring, how does ST analysis (STan) intrapartum monitoring compare to conventional cardiotocography for selected neonatal and maternal outcomes


Sponsor

Chris Wilkinson

Enrollment

1,176 participants

Start Date

Aug 25, 2015

Study Type

Interventional

Conditions

Summary

This is a randomised controlled trial comparing a programme of monitoring unborn babies during labour using ST analysis (STan) of fetal ECG to intrapartum cardiotography. We aim to reduce our emergency caesarean section rate from 18% to 12% with improvement or clinical equivalence of neonatal outcomes, whilst maintaining maternal wellbeing and both maternal and caregiver satisfaction. The WCH is the first Australian centre to introduce STan fetal monitoring, as a part of a comprehensive educational package on fetal monitoring.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria2

  • At least 18 years and capable of giving consent. Pregnancy expected to labour and deliver vaginally, singleton fetus, cephalic presentation, suitable for STan monitoring.
  • Gestation must be greater than 36 completed weeks.

Exclusion Criteria1

  • Planned caesarean section; placenta praevia; low placenta; active vaginal infection; active genital herpes; HIV positive.

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Interventions

Arm 1; Cardiotocographic monitoring only, using a external fetal doppler heart rate transducer strapped around the maternal waist or a metal scalp clip attached to the babies scalp, along with an exte

Arm 1; Cardiotocographic monitoring only, using a external fetal doppler heart rate transducer strapped around the maternal waist or a metal scalp clip attached to the babies scalp, along with an external tocodynometer strapped to the mothers pregnant abdomen. These transducers and pressure monitors are attached to an electronic fetal monitor (CTG machine), which produces a graphic correlation of fetal heart rate to uterine activity. Trained medical and midwifery staff interpret these temporal correlations according to established guidelines. Arm 2: ST analysis (STan) fetal monitoring and cardiotocographic monitoring, using a specialised machine (Neovena STan monitor) that combines cardiotocographic monitoring (as above) with an electrocardiographic (ECG) recording of fetal cardiac activity, requiring a metal scalp clip attached to the unborn babies scalp. This monitoring is only commenced once the cervix is dilated enough and the membranes are ruptured, allowing the clip to be attached. A computerised analysis of the fetal ECG ST segment by the STan monitor provides additional information that is interpreted by guidelines developed by Neoventa by trained medical and midwifery staff. The randomisation is performed when the decision is made during labour by medical or midwifery staff that electronic fetal monitoring is necessary, and the monitoring is continued until delivery of the baby.


Locations(1)

Womens and Childrens Hospital - North Adelaide

SA, Australia

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ACTRN12615001308583