Reducing operative birth for fetal distress in women with small or suboptimally grown infants - The RidStress 2 Randomised Controlled Trial

Phase 3

Recruiting

Conditions: Operative birth (caesarean or instrumental birth)
Birth asphyxia
Small for gestational age infants
Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth - Childbirth and postnatal care
Reproductive Health and Childbirth - Complications of newborn

Registration Number: ACTRN12621000354886

Lead Sponsor: Mater Misericordiae Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 660

Inclusion Criteria

1. Singleton pregnancy
2. Planning a vaginal birth at term (>37 weeks gestation)
3. Aged >18 years and able to give informed consent
4. Pregnancy complicated by suspected small for gestational age (SGA) infant or late fetal growth restriction (FGR) (see below definitions)

SGA is defined as Estimated Fetal Weight (EFW) or Abdominal Circumference (AC) <10th centile for gestation based on ultrasound assessment.

FGR is defined as EFW or AC <3rd centile or two out of three of the following:
1. EFW or AC <10th centile.
2. AC or EFW crossing centiles by >two quartiles on growth charts.
3. Cerebroplacental ratio (CPR) <5th centile or Umbilical Artery Pulsatility Index (UA PI) >95th centile for gestation.

Exclusion Criteria

1.Two or more previous CS births
2.Previous classical CS
3.Major fetal anomaly in this pregnancy
4.Non-cephalic presentation
5.Severe hepatic or renal impairment
6.Participants who are taking any type of nitrate drug therapy or who utilize short-acting nitrate-containing medications during labour [such as sodium nitroprusside, bosentan, fosamprenavir and ritonavir combination, hepatic enzyme inhibitors CYP3A4 (including itraconazole, ketoconazole, ritonavir, cimetidine, erythromycin, saquinavir, darunavir), or hepatic enzyme substrates (CYP3A4), medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors like riociguat], due to the risk of potentially life-threatening hypotension.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Emergency caesarean section for fetal distress (defined contemporaneously as an abnormality in fetal heart rate pattern, fetal scalp lactate or pH level). This will be assessed after review of participant's medical record.[ At delivery of the baby.]

Secondary Outcome Measures

Name	Time	Method
Any operative birth (caesarean section or instrumental vaginal birth) for fetal distress (defined contemporaneously as an abnormality in fetal heart rate pattern, fetal scalp lactate or pH level). This will be assessed after review of participant’s medical record.[ At delivery of the baby.];Health economic costs assessed after review of inpatient and outpatient medical records, emergency department records, Medicare data and prescription pharmaceuticals funded through the PBS scheme.[ 2 years post delivery (when child reaches the age of 2 years)];Childhood neurodevelopmental outcomes as assessed by a paediatric neuropsychologist. This data will be assessed directly as part of the study protocol. It will not be collected from the medical records.[ 2 years post delivery (when child reaches the age of 2 years)]