The iHOLDS Trial: High Or Low Dose Syntocinon for induction of labour

INTERVENTION: A pilot stage will be conducted to assess continuation of recruitment against predefined criteria using a traffic light system; these consider recruitment, treatment adherence and outcome data. The Trial Steering Committee will meet to assess these criteria and report their recommendations to the Sponsor and Funder regarding continuation of the trial. The clinical pathway for nulliparous women recruited to iHOLDS is no different to those undergoing induction of labour who require oxytocin as standard care, other than the dose regimen that is given and the completion of the birth satisfaction questionnaire. A discussion between the woman and the clinical team will take place whenever the induction is booked, and information, including a Participant Information Leaflet (PIL), will be given/sent to women. For some women, induction is booked in advance and for others, the decision is made immediately prior to the process starting; the PIL may therefore be posted to their home address or issued as an outpatient or inpatient in hospital. Discussion regarding the trial will take place during the period of time that cervical ripening is undertaken, which for most women (either as an inpatient or outpatient) is 24 h or more. During this time, women will not be in early/active labour. Issuing of trial‐related information may be carried out by Clinical Midwives, Research Midwives or Obstetricians (who may also be Investigators for the trial). Eligibility will be confirmed by a GCP target trained Obstetrician. After ample time for consideration and the opportunity to ask further questions, eligible women who may require oxytocin for induction of labour will be consented to the trial by any of the above named GCP ta CONDITION: Induction of labour ; Pregnancy and Childbirth ; Induction of labour PRIMARY OUTCOME: Birth by caesarean section collected on the case report form (CRF) at the birth of baby SECONDARY OUTCOME: ; Maternal outcomes:; 1. Epidural use during labour and birth collected on the CRF at the birth of baby; 2. Duration of the second stage of labour (between full dilation to the birth of the baby) collected on the CRF at the birth of baby; 3. Duration of the third stage of labour (between the birth of the baby to the expulsion of the placenta and membranes) collected on the CRF at the expulsion of the placenta and membranes; 4. Time from randomisation to birth (mins) collected on the CRF at the birth of baby; 5. Time from induction of labour (induction of labour is defined as the process by which labour is started prior to its spontaneous onset by progressive cervical effacement and dilatation and/or artificial stimulation of uterine contractions, leading to active labour and birth) to birth (mins) collected on the CRF at the birth of baby; 6. Mode of birth (spontaneous vaginal birth, instrumental or caesarean section) collected on the CRF at the birth of baby; 7. Degree of perineal trauma collected on the CRF at the birth of baby. Defined as follows:; 7.1. First degree, injury to skin only; 7.2. Second degree, injury to the perineal muscles but not the anal sphincter; 7.3. Third degree, injury to the perineum involving the anal sphincter complex:; 7.3.1. 3a, less than 50% of external anal sphincter thickness torn; 7.3.2. 3b, more than 50% of external anal sphincter thickness torn; 7.3.3. 3c, internal anal sphincter torn; 4. Fourth degree, injury to the perineum involving the anal sphincter complex (external and internal anal sphincter) and anal epithelium.; 8. Reason for, and grade of caesarean section (immediate threat to the life of the woman or fetus, maternal or fetal compromise which is not immediately life‐threatening, no maternal or fetal compromise but needs early delivery, or delivery timed to suit woman or staff) collected on the CRF at the time of caesarean section; 9. Confirmed urinary retention requiring catheterization collected on the CRF at discharge from hospital; 10. Tachysystole ( =5 uterine contractions in 10 mins for a 20 min period) requiring reduction in oxytocin and/or tocolysis collected on the CRF at the birth of baby; 11. Hyperstimulation (=5 uterine contractions in 10 mins for a 20 min period resulting in non‐reassuring or abnormal fetal heart rate) collected on the CRF at the birth of baby; 12. Fetal blood sampling (FBS) during labour or significant ST analysis (STAN) event (for those Units that use ST waveform analysis for intrapartum fetal monitoring) collected on the CRF at the birth of baby; 13. Abnormal cardiotocogram leading to immediate birth without fetal blood sample collected on the CRF at the birth of baby; 14. Active management of third stage of labour collected on the CRF at the birth of baby; 15. Length of time after birth in hospital (days) collected on the CRF at discharge from hospital; 16. Admission to HDU and/or ITU collected on the CRF at discharge from hospital; 17. Maternal death collected on the CRF at maternal death; 18. Satisfaction with care and the experience of labour measured using the Birth Satisfaction Scale‐Revised Index (Maternal Satisfaction Questionnaire) at 2 weeks post‐birth; ; Process outcomes:; 1. Time from randomisation to commencement of allocation (mins) collected on the CRF between recruitment and allocation; 2. Total oxytocin dose [IU] collected on the CRF at the birth of baby; 3. Time to maximum oxytocin rate (mins) collected on the CRF at the birth of baby; 4. Maximum oxytocin dose reached collected on the CRF at the birth of baby; ; Neonatal outcomes:; 1. Birthweight collected on the CRF at the birth of baby; 2. Apgar score at 5 min collected on the CRF at the birth of baby; 3. Venous and arterial cord blood gases and pH collected on the CRF at the birth of baby; 4. Need for resuscitation collected on the CRF at the birth of baby; 5. Breastfeeding on discharge from hospital collected on the CRF at discharge from hospital; 6. Length of time after birth in hospital (days) collected on the CRF at discharge from hospital; 7. Birth trauma (brachial plexus injury, fractured clavicle) collected on the CRF at the birth of baby; 8. Need for neonatal review on ward (excluding routine baby check) collected on the CRF at the birth of baby; 9. Use of any antibiotics collected on the CRF at discharge from hospital; 10. Jaundice requiring phototherapy and/or transfusion collected on the CRF at discharge from hospital; 11. Level of Neonatal Unit care received (level 1,2,3) including Intensive Care collected on the CRF at discharge from hospital; 12. Duration of respiratory support (days) collected on the CRF at discharge from hospital; 13. Days to full oral feeds collected on the CRF at discharge from hospital; 14. Meconium aspiration syndrome collected on the CRF at discharge from hospital; 15. Seizures collected on the CRF at discharge from hospital; 16. Neonatal encephalopathy measured using SARNAT grade and collected on the CRF at discharge from hospital; 17. Therapeutic hypothermia (cooling) collected on the CRF at discharge from hospital; 18. Intrapartum stillbirth collected on the CRF at the birth of baby; 19. Early neonatal death (within seven days of birth) collected on the CRF at time of neonatal death; INCLUSION CRITERIA: 1. Nulliparous women at >24 +0/40 weeks gestation 2. Singleton cephalic pregnancy 3. Ruptured membranes undergoing induction of labour 4. Prescribed oxytocin is indicated as part of the induction process 5. Recieved prostin >6 h ago, or propess >30 min ago (if applicable) 6. Clinicians are willing to randomise 7. Give written informed consent to participate prior to randomisation 8. Aged =16 years 9. COVID‐19 positive participants are eligible for study inclusion in accordance with local Trust/Health Board policy