Fetal Membranes, Premature RuptureNCT06262308
Emotional Support for Women Experiencing PPROM
A study testing Psychological intervention along Cognitive Behavioural Therapy principles in people with Fetal Membranes, Premature Rupture and Preterm Birth Complication, run by King's College London at 1 site in United Kingdom.
Trial summary
Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Membranes, Premature Rupture, Preterm Birth Complication
- What is being tested?
- Psychological intervention along Cognitive Behavioural Therapy principles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2024to Mar 2025
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Woman (or birthing person) aged 16 years or over;
- Is experiencing PPROM
- Has been admitted to the ward
- Has capacity to give informed consent to take part in the research
- Speaks and writes English
Who cannot join
- Unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Thomas' Hospital, King's College London
London, Greater London, SE1 7EH
About this study
Official title: Emotional Support for Women Experiencing Preterm Prelabour Rupture of the Membranes (PPROM) - a Research Study
Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women.
Read the detailed description
Preterm Prelabour Rupture of Membranes PPROM affects 3% of all pregnancies. Outcome is variable depending on the time the waters break. Complications include preterm delivery, infection for both mother and baby, umbilical cord prolapse and abruption. In addition if the membranes rupture before 24 weeks women are offered termination of pregnancy due to the risk of pulmonary hypoplasia (underdeveloped lungs). If infection is not present and labour does not occur delivery may be deferred until 37 weeks. Consequently the condition can be associated with prolonged periods of psychological uncertainty.
There is good evidence to suggest that psychological support at the time of traumatic events reduces the long term psychological consequences ie post traumatic stress disorder. Although national guidelines on PPROM suggest psychological support should be available this is not routine clinical practice and no guidance is given on what form of support this should be.
This pilot study aims to develop a talking therapy based on Cognitive Behavioural Therapy principles to support women and garner their feedback.
A series of 5-8 women who are hospitalised in St Thomas' hospital where their waters have broken before 37 weeks into their pregnancy will be approached by a member of the team of doctors/midwives who are looking after them.
Women will be offered an initial session of assessment by a psychologist to gain an individualised understanding of their current anxiety and mood levels and to assess what is causing stress. This may be thoughts, feelings and behaviours relative to their current mood and aspects of the current situation. A set of strategies will be developed such as education about anxiety and responses to traumatic and upsetting situations, modification of negative thoughts, support with excessive reassurance seeking, self-compassionate exercises to help with self-criticism and self-blame, support with decision-making and strategies to manage uncertainty.
Up to 5 further hour long follow up sessions will occur with the time between sessions and number determined by the woman and her circumstances. Due to the levels of uncertainty associated with the situation, each session will be considered as a stand-alone.
Information about their details (such as age, ethnicity, whether they currently have a partner, details of medical conditions, current and previous pregnancies) will be obtained from participants. A brief measure of mood will be collected at each contact and at 4-6 weeks after the final session. The Hospital Anxiety and Depression scale a validated tool will be used to assess mood.
Given that women will be in the midst of a potentially fast-moving medical context may affect scores to some extent, further feedback will be sought from women at the end of each therapy session and beginning of each subsequent session on how useful they have found the session and interventions suggested.
Detailed notes will be kept on the specific techniques employed in each session and suggested as between session practice.
- Being tested
- Psychological intervention along Cognitive Behavioural Therapy principles
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological intervention along Cognitive Behavioural Therapy principlesBehavioural
Women who have PPROM will be offered a series of 6 sessions with a Clinical Psychologist
| Study group | Role | What they receive |
|---|---|---|
| Psychological intervention | Experimental | Women will be given psychological intervention Receives: Behavioral: Psychological intervention along Cognitive Behavioural Therapy principles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood Score 1
The Depression Anxiety Stress Scale 21 (a set of three self reported scales measuring depression anxiety and stress the higher the score the worse the symptoms. For depression 28+ is extremely severe, for anxiety 20+ is extremely severe and 34+ is extremely severe stress).
Measured: Through study on average 3 months
Mood Score 2
Based on the Hospital Anxiety and Depression Scale (this encompasses seven questions scored separately for anxiety and depression, 8-10 is mild, 11-14 is moderate and 15-21 is severe for anxiety/depression)
Measured: Through study on average 3 months
Participant Feedback
Feedback will be sought from participants. This will encompass free text on how useful they felt the sessions had been. A Likert scale will also be incorporated into this questionnaire: score 0-10 (0 not useful, 10 extremely useful).
Measured: Through study and on completion of the study: on average eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Membranes, Premature RuptureStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study where a small cohort of women will give given personalised psychological intervention
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262308
- Sponsor's protocol ID
- 334235
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study only but data will be shared with academic institutions on request
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Support for Women Experiencing Preterm Prelabour Rupture of the Membranes (PPROM) - a Research Study
- ClinicalTrials.gov ID
- NCT06262308
- Acronym / sponsor ID
- 334235
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 16 Feb 2024 (actual)
- 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.
Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women.
Detailed description
Preterm Prelabour Rupture of Membranes PPROM affects 3% of all pregnancies. Outcome is variable depending on the time the waters break. Complications include preterm delivery, infection for both mother and baby, umbilical cord prolapse and abruption. In addition if the membranes rupture before 24 weeks women are offered termination of pregnancy due to the risk of pulmonary hypoplasia (underdeveloped lungs). If infection is not present and labour does not occur delivery may be deferred until 37 weeks. Consequently the condition can be associated with prolonged periods of psychological uncertainty.
There is good evidence to suggest that psychological support at the time of traumatic events reduces the long term psychological consequences ie post traumatic stress disorder. Although national guidelines on PPROM suggest psychological support should be available this is not routine clinical practice and no guidance is given on what form of support this should be.
This pilot study aims to develop a talking therapy based on Cognitive Behavioural Therapy principles to support women and garner their feedback.
A series of 5-8 women who are hospitalised in St Thomas' hospital where their waters have broken before 37 weeks into their pregnancy will be approached by a member of the team of doctors/midwives who are looking after them.
Women will be offered an initial session of assessment by a psychologist to gain an individualised understanding of their current anxiety and mood levels and to assess what is causing stress. This may be thoughts, feelings and behaviours relative to their current mood and aspects of the current situation. A set of strategies will be developed such as education about anxiety and responses to traumatic and upsetting situations, modification of negative thoughts, support with excessive reassurance seeking, self-compassionate exercises to help with self-criticism and self-blame, support with decision-making and strategies to manage uncertainty.
Up to 5 further hour long follow up sessions will occur with the time between sessions and number determined by the woman and her circumstances. Due to the levels of uncertainty associated with the situation, each session will be considered as a stand-alone.
Information about their details (such as age, ethnicity, whether they currently have a partner, details of medical conditions, current and previous pregnancies) will be obtained from participants. A brief measure of mood will be collected at each contact and at 4-6 weeks after the final session. The Hospital Anxiety and Depression scale a validated tool will be used to assess mood.
Given that women will be in the midst of a potentially fast-moving medical context may affect scores to some extent, further feedback will be sought from women at the end of each therapy session and beginning of each subsequent session on how useful they have found the session and interventions suggested.
Detailed notes will be kept on the specific techniques employed in each session and suggested as between session practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study where a small cohort of women will give given personalised psychological intervention
| Arm | Type | Receives |
|---|---|---|
| Psychological intervention | Experimental | Behavioral: Psychological intervention along Cognitive Behavioural Therapy principlesWomen will be given psychological intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Woman (or birthing person) aged 16 years or over;
- Is experiencing PPROM
- Has been admitted to the ward
- Has capacity to give informed consent to take part in the research
- Speaks and writes English
Key exclusion criteria (1 listed)
- Unable or unwilling to give informed consent
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 |
|---|---|---|
| Psychological intervention along Cognitive Behavioural Therapy principlesWomen who have PPROM will be offered a series of 6 sessions with a Clinical Psychologist | Behavioural | Psychological intervention |
Primary outcome
Mood Score 1
Time frame: Through study on average 3 months
The Depression Anxiety Stress Scale 21 (a set of three self reported scales measuring depression anxiety and stress the higher the score the worse the symptoms. For depression 28+ is extremely severe, for anxiety 20+ is extremely severe and 34+ is extremely severe stress).
Mood Score 2
Time frame: Through study on average 3 months
Based on the Hospital Anxiety and Depression Scale (this encompasses seven questions scored separately for anxiety and depression, 8-10 is mild, 11-14 is moderate and 15-21 is severe for anxiety/depression)
Participant Feedback
Time frame: Through study and on completion of the study: on average eight months
Feedback will be sought from participants. This will encompass free text on how useful they felt the sessions had been. A Likert scale will also be incorporated into this questionnaire: score 0-10 (0 not useful, 10 extremely useful).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No. This is a pilot study only but data will be shared with academic institutions on request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological intervention along Cognitive Behavioural Therapy principles in people with Fetal Membranes, Premature Rupture and Preterm Birth Complication, run by King's College London 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 5 inclusion and 1 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 Feb 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood Score 1 (time frame: Through study on average 3 months). The study lists 3 primary outcomes in all. 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 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.