An interventional study of Expectant management and Minimal Vaginal examinations (only when necessary) in Prelabour Rupture of Membranes at Term, sponsored by University of Central Lancashire. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-16.
Sponsored by University of Central Lancashire · Not applicable, Interventional, and Treatment
This is a pilot study that will eventually result in a main randomised controlled trial that will look at what management is associated with a higher rate of normal birth and a lower rate of chorioamnionitis (maternal infection) when women break their waters but labour does not start. Spontaneous rupture of the membranes (when the waters break) at term (37-42 weeks gestation) is a physiological event that happens during labour. However, according to Gunn et al. (1970) in 8-10 % of the cases the membranes rupture before labour starts. The time between the rupture and the onset of labour is called latent phase and time wise is variable.
Studies have showed no statistically significant differences in terms of neonatal infection or chorioamnionitis when the investigators induce labour with prostaglandins compared to when labour starts spontaneously (Hannah et al 1996). Seaward et al. (1997) noted a number of confounding factors that might relate to the incidence of chorioamnionitis (maternal infection), the strongest predictor was having more than 8 vaginal examinations since the rupture of membranes and before delivery which was a stronger predictor than the duration of the latent phase. It is thought that by reducing the number of internal examinations, chorioamnionitis may be reduced, and hence neonatal infection may also be reduced. The main RCT will compare clinical outcomes and maternal satisfaction when women consent to be randomized to four groups: (1) Active management and routine internal examinations during labour, (2) Active management and reduced internal examinations, (3) Expectant management and routine internal examinations, (4) Expectant management and reduced internal examinations.
This application seeks ethics approval for the pilot phase to ensure that a definitive study can be undertaken appropriately. It is important to test that all the components work well individually and as a whole, to estimate sample size and ultimately to test the integrity of the research protocol before embarking on the main trial.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 334 interventional studies indexed under Rupture.
Browse Rupture studies →University of Central Lancashire is the lead sponsor of 31 studies on the registry; 10 are open to participants now.
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Exclusion criteria:
Expectant management up to approximately 96hours and vaginal examinations only when necessary during active labour
Procedure: Expectant management · Procedure: Minimal Vaginal examinations (only when necessary)
Expectant management up to approximately 96hours and routine vaginal examinations during active labour
Procedure: Expectant management · Procedure: Routine vaginal examinations
Induction of labour at approximately 24hours and vaginal examinations only when necessary during active labour
Procedure: Minimal Vaginal examinations (only when necessary) · Procedure: Active management
Induction of labour at approximately 24hours and routine vaginal examinations
Procedure: Active management · Procedure: Routine vaginal examinations
Percentage of eligible women who agree to take part in the study
Time frame: 12 months during pilot stage
Percentage of participants who stay in the allocation arm
Time frame: 12 months during pilot stage
Percentage of participants who find the interventions acceptable
Acceptability of the interventions to participants as measured by the study questionnaire
Time frame: The questionnaire will be completed by the participants between 4-8 weeks after giving birth
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University of Central Lancashire