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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
Sponsor:
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

Brief Summary:
This study will evaluate if providing women diagnosed with an intrauterine pregnancy of uncertain viability with a percentage likelihood of ongoing viability of their pregnancy at the time of the follow-up ultrasound, will result in improved psychological well-being (reduced anxiety and depression). Recruited women will be randomised to either receive the prediction score (intervention arm) or not (control arm).

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
Allocation: Non-Randomized
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)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years+
  • Diagnosis of IPUVI on initial ultrasound

Exclusion Criteria:

  • Current mental health condition (anxiety, depression, eating disorder). The condition will be considered current if it has required one or more consultations with a medical professional (including a psychologist) over the past 6 months (women with past mental health condition will not be excluded)
  • The patient is planning a termination
  • Multiple order pregnancies
  • Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study

Information from the National Library of Medicine

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


Contacts
Contact: Kim K Lawson, MBChB 02033155070 kimlawson@nhs.net
Contact: Cecilia Bottomley, MRCOG MD 02033155070 cecilia.bottomley@chelwest.nhs.uk

Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Investigators
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
  Study Documents (Full-Text)

Documents provided by Chelsea and Westminster NHS Foundation Trust:

Publications:

Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03264170     History of Changes
Other Study ID Numbers: C&W17/082017
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No