Induction of labour Pregnancy and Childbirth Induction of labour
Conditions
Interventions
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 c
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 ripe
Sponsors
Birmingham Women’s and Children’s NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Nulliparous women who: 1. Are in the second stage of labour 2. Have any of the following conditions: 2.1. Existing cardiac disease 2.2. Bleeding disorders 2.3. Previous uterine surgery 2.4. Significant antepartum haemorrhage 3. Have a known contra-indication to oxytocin therapy 4. Are participating in other interventional trials of an Investigational Medicinal Product (IMP) or procedure for induction of labour
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Birth by caesarean section collected on the case report form (CRF) at the birth of baby | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed