Prelabour Rupture of Membranes at TermNCT02872883
A Pilot RCT on the Management of Term Prelabour Rupture of Membranes
A study testing Expectant management, Minimal Vaginal examinations (only when necessary) and Active management in people with Prelabour Rupture of Membranes at Term, run by University of Central Lancashire at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prelabour Rupture of Membranes at Term
- What is being tested?
- Expectant management, Minimal Vaginal examinations (only when necessary) and Active management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Lancashire Teaching Hospitals NHS Trust
Preston, Lancashire
Ann Docherty, Research midwife, ann.docherty@lthtr.nhs.uk
About this study
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"
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
- Being tested
- Expectant management, Minimal Vaginal examinations (only when necessary), Active management, Routine vaginal examinations
- Keywords
- Prelabour rupture of membranes, term pregnancy, management, vaginal examination, induction of labour, expectant management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectant managementProcedure or surgery
Minimal Vaginal examinations (only when necessary)Procedure or surgery
Active managementProcedure or surgery
Routine vaginal examinationsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Expectant management and minimal vaginal examinations | Experimental | Expectant management up to approximately 96hours and vaginal examinations only when necessary during active labour Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: Active management; Procedure: Routine vaginal examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible women who agree to take part in the study
Measured: 12 months during pilot stage
Secondary outcomes (2)
Percentage of participants who stay in the allocation arm
Measured: 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
Measured: The questionnaire will be completed by the participants between 4-8 weeks after giving birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prelabour Rupture of Membranes at TermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- Lancashire Care NHS Foundation Trust
- Responsible party
- Principal investigator, Lucia Ramirez-Montesinos, University of Central Lancashire
- Investigators
- Lucia Ramirez-Montesinos, MSc BSc, Principal investigator, University of Central LancashireSoo Downe, PhD MSc BSc, Study director, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872883
- Sponsor's protocol ID
- STEMH-503
- Other IDs
- U1111-1185-3426
- Status last verified
- Nov 2016
- First submitted
- 14 Jul 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT02872883
- Acronym / sponsor ID
- STEMH-503
- Conditions
- Prelabour Rupture of Membranes at Term
- Keywords
- Prelabour rupture of membranes, term pregnancy, management, vaginal examination, induction of labour, expectant management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- Lancashire Care NHS Foundation Trust
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Expectant management and minimal vaginal examinations | Experimental | Procedure: Expectant management, Procedure: Minimal Vaginal examinations (only when necessary)Expectant management up to approximately 96hours and vaginal examinations only when necessary during active labour |
| Expectant management and routine vaginal examinations | Experimental | Procedure: Expectant management, Procedure: Routine vaginal examinationsExpectant management up to approximately 96hours and routine vaginal examinations during active labour |
| Active management and minimal vaginal examinations | Experimental | Procedure: Minimal Vaginal examinations (only when necessary), Procedure: Active managementInduction of labour at approximately 24hours and vaginal examinations only when necessary during active labour |
| Active management and routine vaginal examinations | Active comparator | Procedure: Active management, Procedure: Routine vaginal examinationsInduction of labour at approximately 24hours and routine vaginal examinations |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expectant management | Procedure or surgery | Expectant management and minimal vaginal examinations, Expectant management and routine vaginal examinations |
| Minimal Vaginal examinations (only when necessary) | Procedure or surgery | Active management and minimal vaginal examinations, Expectant management and minimal vaginal examinations |
| Active management | Procedure or surgery | Active management and minimal vaginal examinations, Active management and routine vaginal examinations |
| Routine vaginal examinations | Procedure or surgery | Active management and routine vaginal examinations, Expectant management and routine vaginal examinations |
Primary outcome
Percentage of eligible women who agree to take part in the study
Time frame: 12 months during pilot stage
2 secondary outcomes
Percentage of participants who stay in the allocation arm
Time frame: 12 months during pilot stage
Percentage of participants who find the interventions acceptable
Time frame: The questionnaire will be completed by the participants between 4-8 weeks after giving birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Ramirez-Montesinos, MSc BSc principal investigator
University of Central Lancashire
Soo Downe, PhD MSc BSc study director
University of Central Lancashire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expectant management, Minimal Vaginal examinations (only when necessary) and Active management in people with Prelabour Rupture of Membranes at Term, run by University of Central Lancashire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia Ramirez-Montesinos, MSc BSc (00447897236172, Lramirez-montesinos@uclan.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible women who agree to take part in the study (time frame: 12 months during pilot stage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.