Clinical trial NCT02872883: A Pilot RCT on the Management of Term Prelabour Rupture of Membranes
Official title: "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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prelabour Rupture of Membranes at Term
Keywords: Prelabour rupture of membranes
term pregnancy
management
vaginal examination
induction of labour
expectant management
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
Collaborators: name: Lancashire Care NHS Foundation Trust
First posted: 2016-08-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of eligible women who agree to take part in the study
timeFrame: 12 months during pilot stage
Secondary outcomes:
measure: Percentage of participants who stay in the allocation arm
timeFrame: 12 months during pilot stage
measure: Percentage of participants who find the interventions acceptable
timeFrame: The questionnaire will be completed by the participants between 4-8 weeks after giving birth
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Trust
state: Lancashire
Study officials:
affiliation: University of Central Lancashire
name: Lucia Ramirez-Montesinos, MSc BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Central Lancashire
name: Soo Downe, PhD MSc BSc
role: STUDY_DIRECTOR
References: