Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06262308 |
| Other study ID # |
334235 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2024 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
February 2024 |
| Source |
King's College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
