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High Or low dose Syntocinon® for delay in labour

Phase 3
Completed
Conditions
ulliparous 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
Registration Number
ISRCTN99841044
Lead Sponsor
Birmingham Womens NHS Foundation Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
1500
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of caesarean section, data taken from medical notes
Secondary Outcome Measures
NameTimeMethod
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