The Randomisation Process Two methods of randomisation

The Randomisation Process

Two methods of randomisation • Via the CORONIS secure website • Via the CORONIS automated telephone system A woman can only be randomised into the trial ONCE

Via the CORONIS Web Site • Web randomisation is used during the hours the Regional Trial Office (RTO) is staffed. • Participating doctors make a phone call to the Regional Trial Office.

Via the CORONIS Web Site

Secure randomisation site This site is accessed by RTO staff when entering study entry details given by participating doctors over the telephone.

Hospital and doctor codes You will be asked to give your hospital code and your personal doctor code before randomisation can continue.

Baseline data You will asked to answer the questions from the At Study Entry page. You should complete these questions on the At Study Entry page before making the call to the Regional Trial Office to randomise the woman.

Allocation Envelope Number A four digit allocation envelope number will be given when all the questions from the At Study Entry page have been answered. This process takes about 2 minutes.

Recording the allocation number The four digit allocation number should be written clearly in the four boxes on the At Study Entry page.

Via the CORONIS Automated Telephone System

Via the CORONIS Automated Telephone System • The CORONIS automated telephone system is used when there are no staff in the Regional Trial Office, e. g. night-time, weekends, holidays OR there is no connection to the internet. • Participating doctors call the automated telephone system using the telephone number displayed in the labour room.

Via the CORONIS Automated Telephone System 1. Enter the data from the Study Entry page (baseline data) using the telephone keypad. Example: Has the women given consent, press 1 for Yes or 0 for NO? Answer the question by pressing 1 or 0 on the telephone keypad 2. The questions will usually be asked in English. 3. At the end of the call the Allocation Envelope Number will be given (4 digits). 4. The four digit number should be recorded on the At Study Entry page.

Recording the allocation number The four digit allocation number should be written clearly in the four boxes on the At Study Entry page.

Allocation Form The Allocation Form inside the Allocation Envelope looks like this. The form describes the procedures to be used for the woman randomised. Study Number: 07/0123 IMPORTANT: • Tick relevant boxes in the Data Collection Booklet to show allocation opposite. • Collect sutures (if applicable). • Put this Allocation Form in woman’s notes to accompany her to theatre. • Put up in theatre to ensure correct allocation is followed during surgery. • After surgery put this form in the woman’s Data Collection Booklet. Blunt abdominal entry Single layer closure of the uterus Non-closure of the peritoneum All other techniques should be as routine practice.