Fetal scalp blood pH or lactate determination in the management of intrapartum fetal distress: A randomised controlled multi-centre trial

INTERVENTION: Of the 3,007 participants recruited and randomised, 15 participants were excluded due to multiple pregnancies or gestational age <34 weeks. Final analysis was carried out on 2,992 cases, 1,496 in each arm. Oral and written information about the trial was given to possible participants at the antenatal clinic in late pregnancy. Oral consent was obtained from the participants at antenatal follow up visits or in early labour. Randomisation of participants to the two arms was performed at the time a clinician decided to perform a fetal scalp blood analysis. Interventions: Fetal scalp blood analysis for pH or lactate as basis for decision to intervene (cesarean section or instrumental delivery) or not. CONDITION: Intrapartum fetal monitoring ; Pregnancy and Childbirth ; Intrapartum fetal monitoring PRIMARY OUTCOME: Prevalence of metabolic acidemia or pH less than 7.00 SECONDARY OUTCOME: Secondary outcome measures: ; 1. Protocol violation (mainly due to failed sampling or analysis); 2. Rate of instrumental deliveries ; 3. Rate of cesarean section ; 4. Apgar score less than 7 at 5 min; 5. Admissions to neonatal intensive care unit; ; Tertiary outcome measures: ; 1. Prevalence of pH less than 7.10; 2. Rate of intervention due to fetal distress; 3. Rate of Hypoxic Ischemic Encephalopathy (HIE) INCLUSION CRITERIA: 1. Women in labour with a singleton pregnancy 2. Gestational age >34 weeks 3. Cephalic presentation 4. Clinical situation where a fetal scalp blood sampling was indicated 5. Those who had given consent