A Pilot RCT on the Management of Term Prelabour Rupture of Membranes

Study Overview
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Brief Summary
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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.

Official Title
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Active vs Expectant Management and Routine vs Only-when-necessary Vaginal Examinations During Labour for Prelabour Rupture of Membranes at Term, a Pilot RCT Study

Conditions
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Prelabour Rupture of Membranes at Term

Intervention / Treatment
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* Procedure: Expectant management
* Procedure: Minimal Vaginal examinations (only when necessary)
* Procedure: Active management
* Procedure: Routine vaginal examinations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prelabour rupture of membranes (confirmed) Term pregnancy - from 37+0 till 41+2 weeks gestation (both inclusive) Normal/Low risk pregnancy Singleton, cephalic pregnancy No known current infectious diseases Aged 18-45 years old Understands English and is able to read and write in English Agree for their placentas to be sent to histology if clinical signs of infection Not taking part in other clinical research at present Consent to take part Exclusion criteria: Pregnancy of 36+6 or less or 41+3 or more weeks gestation Breech or oblique presentation Twin or multiple pregnancy Previous caesarean section Meconium stained liquor Pre-eclampsia Diabetes Known to be colonised by Group B streptococcus Current infections: HIV, Hepatitis B, Herpes Doesn't give consent for the placenta to be sent to histology if clinical signs of infection Not able to understand, read or write in English Currently taking part in other clinical research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expectant management and minimal vaginal examinations<br>Expectant management up to approximately 96hours and vaginal examinations only when necessary during active labour | Procedure: Expectant management<br> <br> Procedure: Minimal Vaginal examinations (only when necessary)<br> <br> |
| Experimental: Expectant management and routine vaginal examinations<br>Expectant management up to approximately 96hours and routine vaginal examinations during active labour | Procedure: Expectant management<br> <br> Procedure: Routine vaginal examinations<br> <br> |
| Experimental: Active management and minimal vaginal examinations<br>Induction of labour at approximately 24hours and vaginal examinations only when necessary during active labour | Procedure: Minimal Vaginal examinations (only when necessary)<br> <br> Procedure: Active management<br> <br> |
| Active Comparator: Active management and routine vaginal examinations<br>Induction of labour at approximately 24hours and routine vaginal examinations | Procedure: Active management<br> <br> Procedure: Routine vaginal examinations<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of eligible women who agree to take part in the study |  | 12 months during pilot stage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who stay in the allocation arm |  | 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 | The questionnaire will be completed by the participants between 4-8 weeks after giving birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prelabour rupture of membranes, term pregnancy, management, vaginal examination, induction of labour, expectant management