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

Not Applicable

Suspended

• Conditions: Induction of labour; Pregnancy and Childbirth

• Registration Number: ISRCTN79220656
• Lead Sponsor: Birmingham Women’s and Children’s NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 4 December 2023
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Suspended
• Sex: Female
• Target Recruitment: 2400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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