gms | German Medical Science

4. Internationale Fachtagung der Deutschen Gesellschaft für Hebammenwissenschaft (DGHWi)

Deutsche Gesellschaft für Hebammenwissenschaft e. V.

16.02.2018, Mainz

The design, set up and preliminary findings of a pilot RCT on the management of prelabour rupture of membranes at term

Meeting Abstract

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  • corresponding author Lucia Ramirez-Montesinos - University of Central Lancashire, Lancashire, United Kingdom
  • Soo Downe - University of Central Lancashire, Lancashire, United Kingdom

Deutsche Gesellschaft für Hebammenwissenschaft. 4. Internationale Fachtagung der Deutschen Gesellschaft für Hebammenwissenschaft (DGHWi). Mainz, 16.-16.02.2018. Düsseldorf: German Medical Science GMS Publishing House; 2018. Doc18dghwiV04

doi: 10.3205/18dghwi04, urn:nbn:de:0183-18dghwi041

Veröffentlicht: 13. Februar 2018

© 2018 Ramirez-Montesinos et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe



Background: About 10% of women experience pre-labour rupture of membranes at term and the time between the rupture of membranes and the onset of labour can vary from woman to woman. Since it is believed that the risk of infection to mother and baby increases once the membranes are ruptured, two main management options are considered: Inducing labour soon after the rupture of the membranes (active management) [1], and Watchful waiting for spontaneous labour while monitoring maternal and baby’s wellbeing (expectant management) [2]. There is controversy as to which one is associated with higher rates of normal birth and lower rates of chorioamnionitis (maternal infection) and neonatal infection. There is also evidence that shows that the number of vaginal examinations is one of the strongest correlators of chorioamnionitis. However, it is believed that this is the first clinical trial on expectant management and an approach of minimal vaginal examinations.

Objective: The objective of this presentation is to discuss how the protocol for the pilot RCT was developed, set up and its preliminary findings.

Methods: A pilot trial was conducted prior to the main trial, to make sure that the study protocol works effectively and also to test that all the components work well together before embarking into the main study. The acceptability of the interventions was also assessed and it was measured with the help of the childbirth experience questionnaire [3] and 10 study-specific questions.

The design of the protocol included consultations with women who were either pregnant or were pregnant in the past year or so and clinicians (Obstetricians, midwives, neonatologists, and managers). Involving patients and the public in research, is also called PPI (patient and public involvement) in the UK. The protocol for the pilot RCT allocated women randomly to the following groups: 1) Expectant management and minimal vaginal examinations, 2) Expectant management and routine four-hourly vaginal examinations, 3) Active management and minimal vaginal examinations and 4) Active management and routine four-hourly vaginal examinations during labour.

In this study, expectant management refers to watchful waiting for spontaneous labour to occur while observing for signs of infection. If labour has not occurred, Induction of labour is offered approximately 96 hours after the rupture of membranes. Active management refers to early induction of labour approximately 24 hours after the rupture of the membranes, should labour have not occurred.

In order to monitor the progress of labour, two main approaches are compared, 1) routine four-hourly vaginal examinations and 2) minimal vaginal examinations - when the clinician will use clinical judgement and external signs of progress as well as cervical dilatation, with the aim of performing as few vaginal examinations as possible.

Results: Developing the protocol for this study was an ongoing process, that was re-visited at every step of the way as new challenges arrived. The protocol was piloted in a maternity unit in England, and further adjustments were made during the data collection period. About 45–50% of the women who were eligible took part in the study which shows that about one in two women would be willing to have expectant management. The engagement during the study was high, with 70–75% of participants completing and returning the questionnaires. The preliminary findings will be presented at the conference.

Discussion and conclusion: This presentation will discuss the process of designing and setting up the protocol for the pilot RCT, and will briefly discuss its preliminary findings. There are no previous randomised controlled trials that have looked at the effects of expectant management in combination with an approach that aims to reduce the number of vaginal examinations that women have during labour.

Ethical criteria and conflict of interests: This research/project as approved by an ethics committee. It is self-funded and there is no conflict of interests.


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Dencker A, Taft C, Bergqvist L, Lilja H, Berg M. Childbirth experience questionnaire (CEQ): development and evaluation of a multidimensional instrument. BMC Pregnancy Childbirth. 2010;10:81. DOI: 10.1186/1471-2393-10-81 Externer Link