A Pilot RCT on the Management of Term Prelabour Rupture of Membranes
NCT ID: NCT02872883
Last Updated: 2016-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2016-11-30
2017-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Expectant management and minimal vaginal examinations
Expectant management up to approximately 96hours and vaginal examinations only when necessary during active labour
Expectant management
Minimal Vaginal examinations (only when necessary)
Expectant management and routine vaginal examinations
Expectant management up to approximately 96hours and routine vaginal examinations during active labour
Expectant management
Routine vaginal examinations
Active management and minimal vaginal examinations
Induction of labour at approximately 24hours and vaginal examinations only when necessary during active labour
Minimal Vaginal examinations (only when necessary)
Active management
Active management and routine vaginal examinations
Induction of labour at approximately 24hours and routine vaginal examinations
Active management
Routine vaginal examinations
Interventions
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Expectant management
Minimal Vaginal examinations (only when necessary)
Active management
Routine vaginal examinations
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Lancashire Care NHS Foundation Trust
NETWORK
University of Central Lancashire
OTHER
Responsible Party
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Lucia Ramirez-Montesinos
Miss
Principal Investigators
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Lucia Ramirez-Montesinos, MSc BSc
Role: PRINCIPAL_INVESTIGATOR
University of Central Lancashire
Soo Downe, PhD MSc BSc
Role: STUDY_DIRECTOR
University of Central Lancashire
Locations
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Lancashire Teaching Hospitals NHS Trust
Preston, Lancashire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ann Docherty, Research midwife
Role: primary
Other Identifiers
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U1111-1185-3426
Identifier Type: OTHER
Identifier Source: secondary_id
STEMH-503
Identifier Type: -
Identifier Source: org_study_id