Once a participant has agreed to join the trial, the clinical research fellow will record, on a standard form, identifying and contact information to be kept locally.
Full name, address, telephone number (home and mobile)
Date of birth
NHS hospital number and CHI number (if available)
General practitioner and hospital consultant name and address
Unique trial number (to be issued by CHaRT after recruitment)
This information will not be sent to the trial office, but will be kept locally (in a locked cabinet) by the clinical research fellow as a linkage between the trial number and the patient's identity. The following information will be sent to the trial office as participant identifiers.
Initials, date of birth, hospital number, Bishop score
Unique trial number (to be issued by CHART)
The patient's case notes will be regarded as source data/documents. The local investigators (grantholders and clinical research fellow appointed to the study) will have access to the source data and will extract the data required for the CRF. A trial manager from CHaRT (Centre for Healthcare Randomised Trials) will also access source data to ensure quality control. No patient identifying information will leave the hospital.
The clinical research fellow will enter study CRFs onto the study database held by CHaRT in Aberdeen within one month of subject completion of the trial (defined as discharge of mother and baby from hospital) via the IMOP study web portal. CHART staff will work closely with the clinical research fellow to secure as complete and accurate data as possible. Extensive range and consistency check will further enhance the quality of the data.
CHaRT will make site visits to the study centre (PRM) to ensure quality control and quality assurance. A random sample of patient records will be reviewed to ensure accurate transcription onto the CRFs. CHaRT will review incoming CRFs and ask the clinical research fellow to complete missing data, and to clarify anomalies.
Ethics and other regulatory issues
The study has MREC approval from the West Glasgow Ethics Committee 1 (04/S0703/35) (see additional file no 1) and LREC approval from Glasgow Royal Infirmary/Princess Royal Maternity. The MREC, will be informed of amendments to the protocol or patient information. The LREC will also be informed of these amendments at MREC's request. The study had a DDX exemption from the MHRA (13608), which was subsequently "rolled over" into a CTA. The study has been registered on the EUDRAct database 2004-000995-15.
Data Monitoring Committee
A Data Monitoring Committee (DMC) will be established. This will consist of two obstetricians and a statistician and will be independent of the trial organisers. The DMC will advise the Steering Committee if, in its view, one or more of the randomised comparisons in the trial has provided both (a) proof beyond reasonable doubt that for all or some types of patients one particular type of intervention is clearly indicated in terms of a reduction in the induction to delivery interval, (or clearly contraindicated because of a net increase in induction to delivery interval or other adverse events), and (b) evidence that might reasonably be expected to influence materially the care of women having induction of labour by clinicians who know the results of this and comparable trials. The Steering Committee will then decide whether or not to modify intake to the trial. Unless this happens, however, the steering committee, clinical collaborators, and trial office staff (except those who supply the confidential analyses) will remain ignorant of the interim results. (Note that appropriate criteria for proof beyond reasonable doubt cannot be specified precisely. A difference of at least three standard deviations in the interim analysis of a major endpoint may be needed to justify halting, or modifying, such a study prematurely. If this criterion were to be adopted, it would have the practical advantage that the exact number of interim analyses would be of little importance, and so no fixed schedule is proposed) .
Interim analysis of some of the clinical outcomes (e.g. caesarean section rate, admission to hospital during ripening phase for reasons other than onset of labour) will be performed by the Data Monitoring Committee after about 180 women have been recruited. Criteria for advising the early termination of the study for safety reasons or for overwhelming evidence of benefit will be determined before any unblinded data is seen, and documented in the Minutes of the meeting of the DMC. There are no plans to stop the study early for futility. Assuming the termination criteria are not satisfied, the results will not be revealed to the investigators or participants, and no further analyses will be performed until data acquisition is complete.
Funding and sponsorship
The study is funded by a research grant from the Charity Wellbeing at the Royal College of Obstetricians and Gynaecologists (see additional file 2). The study "sponsors" (as defined by the EU directive) are Glasgow University and North Glasgow University Hospital Division. The funder of the study has had no input into protocol design.
A fuller version of the study protocol is available at the study website .