Nulliparous women with a singleton cephalic pregnancy at term (37-42 weeks gestation) with confirmed delay in labour and ruptured membranes as defined by NICE Intrapartum Care Guidelines for whom the clinical decision has been made to prescribe Syntocinon for augmentation of labour. Pregnancy and Childbirth
Conditions
Interventions
HOLDS is a double- blinded randomised controlled trial which will compare the standard dose regimen of oxytocin with a high dose regimen. NICE guidance recommends a standard dose regimen of oxytocin (
Sponsors
Birmingham Womens NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Nulliparous women with singleton cephalic pregnancy at term (37-42 weeks gestation) 2. Confirmed delay in labour and ruptured membranes for whom the clinical decision has been made to prescribe Syntocinon for augmentation of labour According to NICE guidance [NICE 2014], labour is established when there are regular painful contractions and progressive cervical dilation from 4 cm. Delay is suspected when cervical dilation of < 2 cm in 4 hours occurs once labour is established. Delay is confirmed when progress of <1 cm in 2 hours is found on repeat vaginal examination.
Exclusion criteria
Exclusion criteria: 1. Multiparous women 2. Nulliparous women who: 2.1. Are undergoing induction of labour 2.2. Have a BMI >40 at booking 2.3. Have a multiple pregnancy 2.4. Have existing cardiac disease, bleeding disorders, diabetes (either pre-existing or gestational), previous uterine surgery 2.5. Have had significant antepartum haemorrhage 2.6. Are under 16 years of age 2.7. Have a known contra-indication to oxytocin therapy as listed in the Summary of marketing Product Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of caesarean section, data taken from medical notes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of epidural use during labour 2. Duration of first, second and third stages of labour 3. Time to birth from randomisation 4. Prevalence of mode of birth (spontaneous vaginal birth (SVB), instrumental or caesarean section) 5. Degree of perineal trauma (first, second, third and fourth) 6. Reason for caesarean section and decision to delivery interval for CS 7. Confirmed urinary retention requiring catheterisation and pulmonary oedema 8. Tachysystole (uterine contractions greater than 5 in 10 mins for 20 minutes) requiring reduction in oxytocin and/or tocolysis 9. Hyperstimulation (uterine contractions greater than 5 in 10 mins for 20 minutes resulting in non-ressurring or abnormal fetal heart rate) 10. Fetal blood sampling (FBS) during labour or significant STAN event (for those Units that use ST waveform analysis for intrapartum fetal monitoring) 11. Abnormal cardiotocogram leading to immediate birth without fetal blood sample 12. Incidence of maternal morbidity (anaphylaxis, pulmonary oedema, postpartum haemorrhage, shoulder dystocia, chorioamnioitis, uterine rupture/hysterectomy) 13. Active management of third stage of labour 14. Length of time after birth in hospital [days] 15. Admission to HDU/ITU 16. Maternal death 17. Time from randomisation to commencement of allocation 18. Total oxytocin dose 19. Time to maximum oxytocin rate 20. Maximum oxytocin dose reached 21. Gender and birthweight of neonate 22. Apgar score at 5 minutes 23. Arterial cord blood gases when collected 24. Breastfeeding rates on discharge from hospital 25. Length of time after birth in hospital [days] 26. Incidence of need to resuscitate neonate 27. Reason for neonatal review on ward (excluding routine baby check) 28. Reason for admission to neonatal unit (NNU) and level of care received (level 1,2,3) including intensive care 29. Duration of respiratory support for neonate 30. Number of days to full oral feeds 31. Incidence of seizures of neon | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactSara Kenyon
Outcome results
None listed