HOLDS - compare standard dose vs high dose syntocinon to stimulate contractions during labour.

Phase 1

• Conditions: Approximately a third of women become delayed in their first labours and are given intravenous oxytocin in an attempt to increase their uterine contractions, increase spontaneous vaginal birth and reduce Caesarean section.; MedDRA version: 21.1 Level: PT Classification code 10000153 Term: Abnormal labour System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2015-005537-50-GB
• Lead Sponsor: Birmingham Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-12
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: A
• Sex: Not specified
• Target Recruitment: 1500

Inclusion Criteria

Inclusion criteria - eligible women will include:

- nulliparous women who are able and willing to give informed consent
- singleton pregnancy of 37-41 weeks plus 6 days gestation
- confirmed delay in labour (using NICE intrapartum care guideline)
- ruptured membranes
- decision to prescribe syntocinon for augmentation of labour

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Multiparous women
• Nulliparous women who have reached full dilation of the cervix (10cm)
•Nulliparpous women undergoing induction of labour
•Nulliparpous women with a BMI >40 at booking
•Nulliparpous women who have a multiple pregnancy
•Nulliparpous women who have existing cardiac disease, bleeding disorders, diabetes (either pre-existing or gestational), scarred uterusprevious uterine surgery,
•Nulliparpous women with significant antepartum haemorrhage
•Women are under 16 years of age
•Women who have a known contra-indication to oxytocin therapy as listed in the Summary of marketing Product Characteristics (SmPC)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: This trial will assess whether high dose regimen oxytocin compared to standard (lower) dose regimen oxytocin will reduce the Caesarean section rate for women with confirmed delay in the first stage of labour,<br><br> ;<br> Secondary Objective: •To assess the effect on maternal and neonatal birth outcomes.<br><br> •To explore any variation in effect in women randomised with cervical dilation <6cms and >=6cms.<br><br> •To assess the safety of high dose oxytocin.<br> ;Primary end point(s): Primary Outcome is Caesarean Section (CS).;Timepoint(s) of evaluation of this end point: This outcome will be determined at birth.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No secondary end point