ISRCTN ISRCTN74323479
DOI https://doi.org/10.1186/ISRCTN74323479
Protocol serial number N0024112467
Sponsor Department of Health (UK)
Funder Homerton University Hospital NHS Trust (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
02/06/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Kevin Harrington
Scientific

Fetal Medicine Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom

Phone +44 (0)20 8510 7544
Email kevin.harrington@virgin.net

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleWhat shall we do with the postdates woman who is not in labour?
Study objectivesCan we reduce the induction to delivery interval and Caesarean section rate in postdates primigravida women undergoing induction of labour with unfavourable cervix?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and Childbirth: Induction of labour
Intervention1. Mifepristone
2. Standard care
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Mifepristone
Primary outcome measure(s)

1. Length of time from induction start (first Prostin) to:
1.1. Onset of labour
1.2. Second stage
1.3. Delivery
1.4.Timing and type of intervention (Caesarian Section, Forceps, Ventouse), if any
2. Antepartum haemorrhage (APH), postpartum haemorrhage (PPH) and other complications
3. Neonatal weight, cord pH and admission to Special Care Baby Unit (SCBU)

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration100
Key inclusion criteria100 pregnant primiparous women who have not laboured at or beyond 41 weeks of gestation with cervival length >3 cm.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/05/2002
Date of final enrolment31/12/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Fetal Medicine Unit
London
E9 6SR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

02/06/2017: No publications found in PubMed, verifying study status with principal investigator