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

NCT02872883 | Unknown DMC

• 2 other identifiers: STEMH-503U1111-1185-3426
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Prelabour Rupture of Membranes at Term

Keywords

Prelabour rupture of membranes; term pregnancy; management; vaginal examination; induction of labour; expectant management

Outcome Measures

Primary Outcomes (1)

• Percentage of eligible women who agree to take part in the study

  12 months during pilot stage

Secondary Outcomes (2)

• Percentage of participants who stay in the allocation arm

  12 months during pilot stage

• Percentage of participants who find the interventions acceptable

  The questionnaire will be completed by the participants between 4-8 weeks after giving birth

Study Arms (4)

Expectant management and minimal vaginal examinations

EXPERIMENTAL

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 and routine vaginal examinations

EXPERIMENTAL

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

Procedure: Expectant management; Procedure: Routine vaginal examinations

Active management and minimal vaginal examinations

EXPERIMENTAL

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

Active management and routine vaginal examinations

ACTIVE COMPARATOR

Induction of labour at approximately 24hours and routine vaginal examinations

Procedure: Active management; Procedure: Routine vaginal examinations

Interventions

Expectant management PROCEDURE

Expectant management and minimal vaginal examinations; Expectant management and routine vaginal examinations

Minimal Vaginal examinations (only when necessary) PROCEDURE

Active management and minimal vaginal examinations; Expectant management and minimal vaginal examinations

Active management PROCEDURE

Active management and minimal vaginal examinations; Active management and routine vaginal examinations

Routine vaginal examinations PROCEDURE

Active management and routine vaginal examinations; Expectant management and routine vaginal examinations

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Lancashire: lead
• Lancashire Care NHS Foundation Trust: collaborator

Study Sites (1)

Lancashire Teaching Hospitals NHS Trust

Preston, Lancashire, United Kingdom

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Lucia Ramirez-Montesinos, MSc BSc

  University of Central Lancashire

  PRINCIPAL INVESTIGATOR

• Soo Downe, PhD MSc BSc

  University of Central Lancashire

  STUDY DIRECTOR

Central Study Contacts

Lucia Ramirez-Montesinos, MSc BSc

CONTACT

00447897236172; Lramirez-montesinos@uclan.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miss

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: August 19, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 16, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)