Emotional Support for Women Experiencing PPROM

NCT06262308 | Not Yet Recruiting

• 1 other identifier: 334235
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fetal Membranes, Premature Rupture; Preterm Birth Complication

Outcome Measures

Primary Outcomes (3)

• 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).

  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)

  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).

  Through study and on completion of the study: on average eight months

Study Arms (1)

Psychological intervention

EXPERIMENTAL

Women will be given psychological intervention

Behavioral: Psychological intervention along Cognitive Behavioural Therapy principles

Interventions

Psychological intervention along Cognitive Behavioural Therapy principles BEHAVIORAL

Women who have PPROM will be offered a series of 6 sessions with a Clinical Psychologist

Psychological intervention

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Pregnant women or individuals who are pregnant
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable or unwilling to give informed consent

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

St Thomas' Hospital, King's College London

London, Greater London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot study where a small cohort of women will give given personalised psychological intervention

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 16, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)