Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262308
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-01
Brief Title:
Emotional Support for Women Experiencing PPROM
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Emotional Support for Women Experiencing Preterm Prelabour Rupture of the Membranes PPROM - a Research Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 doctorsmidwives 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
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 doctorsmidwives 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None