Contact information
Type
Scientific
Primary contact
Mr Dan Selo-Ojeme
ORCID ID
Contact details
Consultant Obstretrician and Gynaecologist
Chase Farm Hospital
The Ridgeway
Enfield
EN2 8JL
United Kingdom
+44 02083751250
dan.selo-ojeme@bcf.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0270181703
Study information
Scientific title
Acronym
Study hypothesis
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
Added 8 September 2008: Barnet, Enfield & Haringey Local Ethics Committee (UK), 20/01/2006, Ref Number 05/Q0509/65.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy and Childbirth: Labour induction
Intervention
Amniotomy and immediate oxytocin infusion versus amniotomy and delayed oxytocin
Intervention type
Drug
Phase
Not Specified
Drug names
oxytocin
Primary outcome measures
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 trial start date
09/01/2005
Overall trial end date
03/01/2006
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
112
Participant 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
Recruitment start date
09/01/2005
Recruitment end date
03/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Obstretrician and Gynaecologist
Enfield
EN2 8JL
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barnet and Chase Farm Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18958483
Publication citations
-
Results
Selo-Ojeme DO, Pisal P, Lawal O, Rogers C, Shah A, Sinha S, A randomised controlled trial of amniotomy and immediate oxytocin infusion versus amniotomy and delayed oxytocin infusion for induction of labour at term., Arch. Gynecol. Obstet., 2009, 279, 6, 813-820, doi: 10.1007/s00404-008-0818-x.