A pilot RCT on the management of term prelabour rupture of membranes

Ramirez-Montesinos, Lucia (2020) A pilot RCT on the management of term prelabour rupture of membranes. Doctoral thesis, University of Central Lancashire.

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About 10% of women experience term pre-labour rupture of membranes. Since it is believed that the risk of infection to mother and baby increases once the membranes are ruptured, two options are considered: (1) Inducing labour soon after the rupture of membranes (active management), and (2) Watchful waiting for spontaneous labour while monitoring maternal and fetal wellbeing (expectant management). There is controversy as to which one is associated with higher rates of normal birth and less infection. Further evidence shows that the number of vaginal examinations is one of the strongest correlators of chorioamnionitis.
To develop and pilot test the protocol for an RCT on expectant management and minimal vaginal examinations for term prelabour rupture of membranes.
Firstly, a systematic review on expectant management and the eect of vaginal examinations was carried out. Secondly, consultations with women, clinicians, and managers took place. Simple thematic analysis was undertaken, and the results informed the study protocol. A pilot RCT was then conducted. Women were allocated to the following groups: 1) Expectant management and minimal vaginal examinations,
2) Expectant management and routine vaginal examinations, 3) Active management and minimal vaginal examinations and 4) Active management and routine vaginal examinations during labour. Low vaginal swabs were taken before the �rst vaginal
examination and after every examination to assess for the presence of exogenous bacteria. Women who were eligible to take part in the RCT but declined, were o�ered participation in an observational study that involved routine clinical practice to aid sample size calculation for the main study. The acceptability of the interventions in the RCT was 3 assessed with the Childbirth Experience Questionnaire (CEQ) and 10 study-speci�c questions.
The systematic review revealed that there is no prior RCT on both expectant management and minimal vaginal examinations during labour. Stakeholder input was crucial in the development of the study protocol. There were 85 eligible women, of those 51% (n=43) took part in the pilot RCT, 40% (n=34) took part in the observational study, and 9% (n=8) did not take part in either. There were 33 (80.5%) questionnaires returned. No safety issues were encountered and the interventions were acceptable to women.
The results from the systematic review and the pilot RCT suggest that a de�nitive study in this area, using the protocol developed during this study, is needed, feasible, and acceptable to women.

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