Emotional Support for Women Experiencing PPROM

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fetal Membranes, Premature Rupture; Preterm Birth Complication
• Intervention / Treatment: Behavioral: Psychological intervention along Cognitive Behavioural Therapy principles

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 Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, SE1 7EH
      • St Thomas' Hospital, King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unable or unwilling to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychological intervention; Women will be given psychological intervention	Behavioral: Psychological intervention along Cognitive Behavioural Therapy principles; Women who have PPROM will be offered a series of 6 sessions with a Clinical Psychologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Rupture; Premature Birth; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: 334235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study only but data will be shared with academic institutions on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No