Background:
Non-physiologic (pharmacological) induction of labour is associated with a higher risk of instrumental vaginal birth, with consequent increased risk of respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended to promote the normal physiological onset of labour, and reduce the need for drug-based induction. However, despite its widespread use, there is an absence of evidence on optimal timing and frequency of membrane sweeping.
Objectives:
To assess the feasibility of conducting a definitive randomised trial to examine the effectiveness of membrane sweeping to prevent drug-based induction of labour in women at or near term, to explore women and clinicians acceptability of and willingness to participate in the trial and to evaluate the effects of social media study promotion on recruitment.
Methods:
Multicentre, feasibility study of 1) a pilot, randomised trial, 2) a descriptive qualitative study and 3) a pilot study within a trial (SWAT).
Pilot randomised trial:
Pregnant women with a live, singleton fetus 38 weeks gestation, cephalic presentation, longitudinal lie, intact membranes, English speaking and 18 years of age will be randomised to one of 4 groups:
1: Membrane sweep @ 39 weeks, 40 weeks and 41 weeks gestation or until onset of labour;
2: Membrane sweep @ 40 weeks and 41 weeks or until onset of labour;
3. Membrane sweep @ 39 weeks only
4: No membrane sweep.
Qualitative study:
To explore women’s and clinician’s acceptability of, and willingness to participate in, the trial.
Up to 20 women participating in the pilot trial will be invited to focus group interviews.
All clinicians involved in the pilot trial will be invited to attend focus group interviews.
SWAT:
A pilot, cluster randomised trial will evaluate the effects of social media promotion oon participant recruitment.
Interventions:
Site 1: Usual onsite study promotion plus social media study promotion
Site 2: Usual onsite study promotion only
Outcomes measures:
Recruitment and retention rates, compliance to protocol, women’s and clinician’s views, randomisation and allocation processes, attrition rates, response rates to maternal questionnaires, sample size analysis estimates for definitive trial, adverse events and social media recruitment rates.
