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

Birth by caesarean section collected on the case report form (CRF) at the birth of baby

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