A cohort of 557 women were recruited of which term singleton and preterm singleton deliveries that underwent induction of labor or Cesarean section were excluded, and after withdrawals formed a study group of 320 women (Figure 1).
An Early Withdrawal Form will be completed only if a patient withdraws their consent.
Participants will be asked to fill in a withdrawal form where they can choose whether or not LifeLines may continue to receive information about their health from their general practitioner and hospital and use this information for research purposesu.
In this assay, cells that survive anchorage withdrawal form multicellular aggregates or oraspheres [ 24, 25].
The information pack includes a withdrawal form and preaddressed envelope, should the patient wish their data to be withdrawn from the study at a later date.
If participants agree to any of the above, they will be asked to complete a confirmation of withdrawal form to document their decision.
The invitation included an information letter as well as consent and withdrawal forms and a pre-addressed and stamped return envelope.
If consent is given, any existing data or samples will be retained, and follow-up data will continue to be collected; if not, then a withdrawal form will be completed.
In addition women will be provided with a withdrawal form and pre-paid envelope, so that if with hindsight they decide not to participate in the study return of the slip will result in withdrawal of their data from the study and destruction of their questionnaire.
Information about expected adverse reactions to bath emollients which are listed in the Summary of Product Characteristics (ie, pruritus, reddening, itching, skin irritation, rash, accidental ingestion, slipping) will be collected in trial questionnaires (or withdrawal form, where applicable) and therefore need not be reported as an adverse event.
