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

University of Central Lancashire

Status: Unknown

Conditions: Prelabour Rupture of Membranes at Term

Treatments: Procedure: Routine vaginal examinations; Procedure: Minimal Vaginal examinations (only when necessary); Procedure: Expectant management; Procedure: Active management

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02872883

U1111-1185-3426 (Other Identifier)

STEMH-503

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Expectant management and minimal vaginal examinations

Experimental group

Description:

Expectant management up to approximately 96hours and vaginal examinations only when necessary during active labour

Treatment:

Procedure: Expectant management

Procedure: Minimal Vaginal examinations (only when necessary)

Expectant management and routine vaginal examinations

Experimental group

Description:

Expectant management up to approximately 96hours and routine vaginal examinations during active labour

Treatment:

Procedure: Expectant management

Procedure: Routine vaginal examinations

Active management and minimal vaginal examinations

Experimental group

Description:

Induction of labour at approximately 24hours and vaginal examinations only when necessary during active labour

Treatment:

Procedure: Minimal Vaginal examinations (only when necessary)

Procedure: Active management

Active management and routine vaginal examinations

Active Comparator group

Description:

Induction of labour at approximately 24hours and routine vaginal examinations

Treatment:

Procedure: Active management

Procedure: Routine vaginal examinations