A randomised controlled trial of amniotomy and immediate oxytocin infusion versus amniotomy and delayed oxytocin infusion for induction of labour at term

ISRCTN	ISRCTN35919840
DOI	https://doi.org/10.1186/ISRCTN35919840
Secondary identifying numbers	N0270181703

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Dan Selo-Ojeme
Scientific

Consultant Obstretrician and Gynaecologist
Chase Farm Hospital
The Ridgeway
Enfield
EN2 8JL
United Kingdom

Phone	+44 02083751250
Email	dan.selo-ojeme@bcf.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	The aim of this study is to compare the efficacy of amniotomy (breaking baby's bag of waters) and immediate syntocinon (oxytocin) infusion with amniotomy and delayed syntocinon infusion in induction of labour at term.
Ethics approval(s)	Added 8 September 2008: Barnet, Enfield & Haringey Local Ethics Committee (UK), 20/01/2006, Ref Number 05/Q0509/65.
Health condition(s) or problem(s) studied	Pregnancy and Childbirth: Labour induction
Intervention	Amniotomy and immediate oxytocin infusion versus amniotomy and delayed oxytocin
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	oxytocin
Primary outcome measure	The proportion of women in active labour after 4 hours and over the course of time
Secondary outcome measures	Added 8 September 2008: 1. Mode of delivery 2. Need for epidural analgesia 3. Incidence of uterine hyperstimulation 4. Abnormal fetal heart recordings (by CTG) 5. 5-minute Apgar score < 7 6. Umbilical arterial cord pH < 7.2 7. Admission to neonatal intensive care unit 8. Womens satisfaction
Overall study start date	09/01/2005
Completion date	03/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	112
Key inclusion criteria	Women that will be invited to take part in the study will be drawn from the antenatal clinic. These women will be identified during routine antenatal clinic sessions. They will be women in their first pregnancy who have past their delivery dates and are thus planned for routine induction of labour. Interested patients will be given the patient information leaflet to take home.
Key exclusion criteria	Added 8 September 2008: Women who decline to participate or with: 1. Preterm pregnancies 2. Multiple pregnancies 3. Regular uterine contractions (≥1 in 10 minutes) 4. Abnormal pre-induction fetal heart rate trace 5. Rupture of membranes 6. Significant fetal or maternal medical condition 7. Previous uterine surgery
Date of first enrolment	09/01/2005
Date of final enrolment	03/01/2006

Consultant Obstretrician and Gynaecologist

Enfield
EN2 8JL
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Barnet and Chase Farm Hospitals NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No