Psychological Impact of Predicting Early Pregnancy Outcomes in Women With Pregnancy of Uncertain Viability (IMPROVE)
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|ClinicalTrials.gov Identifier: NCT03264170|
Recruitment Status : Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uncertain Viability of Pregnancy Anxiety Depression||Diagnostic Test: Prediction of pregnancy outcome||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||All participating women will be randomised to one of two groups at the time of recruitment. The intervention group will receive the prediction score. The control group will not receive the prediction score.|
|Masking:||None (Open Label)|
|Official Title:||Implementation of a Model for Predicting Early Pregnancy Outcome in Women With Pregnancy of Uncertain Viability: a Psychological Impact Study|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||March 2020|
Active Comparator: Prediction of pregnancy outcome
Women will receive an individualised prediction score of the pregnancy being viable at the follow-up ultrasound generated from the prediction tool.
Diagnostic Test: Prediction of pregnancy outcome
The intervention group will receive the individualised prediction of their pregnancy (as a percentage). The prediction is calculated by a validated, accurate mathematical model using specific background information and ultrasound data for each participant.
No Intervention: Control
Women will not receive the prediction score
- A change in self-reported psychological well-being from diagnosis to follow-up between the two groups. [ Time Frame: 14 days ]
To assess and compare if there is any significant difference in symptoms of anxiety and depression during the uncertain period, as measured by the Hospital and Anxiety Depression Score in the two groups of women all diagnosed with IPUVI. The two groups will be; 1) women randomised to receive the prediction tool and 2) women randomised to not receive the prediction tool.
2. To assess and compare whether the symptoms of anxiety and depression in the two groups of women change over three defined time points: immediately after the initial ultrasound/ diagnosis, at 72 hours post ultrasound and immediately prior to the follow-up ultrasound at 14 days.
The questionnaire has two components, one relating to anxiety symptoms (HADS-A) and one relating to depressive symptoms (HADS-D). Each component comprises seven statements. Each statement is scored 0-3 yielding a total of 0-21 points for each component.
- Patient Experience of the prediction tool [ Time Frame: 14 days ]3. To assess the patient experience during the study period by applying a self-reported experience questionnaire on the acceptability and perceived usefulness of the prediction tool, in those women who receive it. The questionnaire has been developed by the study investigators using modified versions of the Technology Acceptance Model by Davis et al, 1989.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264170
|Contact: Kim K Lawson, MBChBfirstname.lastname@example.org|
|Contact: Cecilia Bottomley, MRCOG MDemail@example.com|
|Study Chair:||Cecilia Bottomley, MRCOG MD||Chelsea and Westminster Hospital NHS Foundation Trust|
|Principal Investigator:||Kim K Lawson, MBChB||Chelsea and Westminster Hospital NHS Foundation Trust|