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

"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"

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.

Study Overview

• Status: Unknown
• Conditions: Prelabour Rupture of Membranes at Term
• Intervention / Treatment: Procedure: Expectant management; Procedure: Minimal Vaginal examinations (only when necessary); Procedure: Routine vaginal examinations; Procedure: Active management

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucia Ramirez-Montesinos, MSc BSc; Phone Number: 00447897236172; Email: Lramirez-montesinos@uclan.ac.uk

Study Locations

• United Kingdom
  • Lancashire
    • Preston, Lancashire, United Kingdom
      • Recruiting
      • Lancashire Teaching Hospitals NHS Trust
      • Contact: Ann Docherty, Research midwife; Email: ann.docherty@lthtr.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Expectant management and minimal vaginal examinations; 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)
EXPERIMENTAL: Expectant management and routine vaginal examinations; Expectant management up to approximately 96hours and routine vaginal examinations during active labour	Procedure: Expectant management; Procedure: Routine vaginal examinations
EXPERIMENTAL: Active management and minimal vaginal examinations; 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_COMPARATOR: Active management and routine vaginal examinations; Induction of labour at approximately 24hours and routine vaginal examinations	Procedure: Routine vaginal examinations; Procedure: Active management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Central Lancashire
• Collaborators: Lancashire Care NHS Foundation Trust
• Investigators: Principal Investigator: Lucia Ramirez-Montesinos, MSc BSc, University of Central Lancashire; Study Director: Soo Downe, PhD MSc BSc, University of Central Lancashire

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): October 1, 2017
• Study Completion (ANTICIPATED): November 1, 2017

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (ESTIMATE): August 19, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: management; induction of labour; term pregnancy; expectant management; Prelabour rupture of membranes; vaginal examination
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: STEMH-503; U1111-1185-3426 (OTHER: (Universal Trial Number)The World Health Organisation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO