NCT03264170

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 7, 2018

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

August 21, 2017

Last Update Submit

March 5, 2018

Conditions

Uncertain Viability of PregnancyAnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • A change in self-reported psychological well-being from diagnosis to follow-up between the two groups.

    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.

    14 days

Secondary Outcomes (1)

  • Patient Experience of the prediction tool

    14 days

Study Arms (2)

Prediction of pregnancy outcome

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Women will not receive the prediction score

Interventions

Prediction of pregnancy outcomeDIAGNOSTIC_TEST

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.

Prediction of pregnancy outcome

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Bottomley C, Van Belle V, Mukri F, Kirk E, Van Huffel S, Timmerman D, Bourne T. The optimal timing of an ultrasound scan to assess the location and viability of an early pregnancy. Hum Reprod. 2009 Aug;24(8):1811-7. doi: 10.1093/humrep/dep084. Epub 2009 Apr 10.

    PMID: 19363041BACKGROUND

  • Davison AZ, Appiah A, Sana Y, Johns J, Ross JA. The psychological effects and patient acceptability of a test to predict viability in early pregnancy: a prospective randomised study. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:95-9. doi: 10.1016/j.ejogrb.2014.04.002. Epub 2014 Apr 18.

    PMID: 24837026BACKGROUND

  • Richardson A, Raine-Fenning N, Deb S, Campbell B, Vedhara K. Anxiety associated with diagnostic uncertainty in early pregnancy. Ultrasound Obstet Gynecol. 2017 Aug;50(2):247-254. doi: 10.1002/uog.17214. Epub 2017 Jun 27.

    PMID: 27484256BACKGROUND

  • Bottomley C, Van Belle V, Kirk E, Van Huffel S, Timmerman D, Bourne T. Accurate prediction of pregnancy viability by means of a simple scoring system. Hum Reprod. 2013 Jan;28(1):68-76. doi: 10.1093/humrep/des352. Epub 2012 Oct 30.

    PMID: 23111205BACKGROUND

  • Bottomley C, Van Belle V, Pexsters A, Papageorghiou AT, Mukri F, Kirk E, Van Huffel S, Timmerman D, Bourne T. A model and scoring system to predict outcome of intrauterine pregnancies of uncertain viability. Ultrasound Obstet Gynecol. 2011 May;37(5):588-95. doi: 10.1002/uog.9007.

    PMID: 21520315BACKGROUND

  • Lok IH, Neugebauer R. Psychological morbidity following miscarriage. Best Pract Res Clin Obstet Gynaecol. 2007 Apr;21(2):229-47. doi: 10.1016/j.bpobgyn.2006.11.007. Epub 2007 Feb 20.

    PMID: 17317322BACKGROUND

  • Farren J, Jalmbrant M, Ameye L, Joash K, Mitchell-Jones N, Tapp S, Timmerman D, Bourne T. Post-traumatic stress, anxiety and depression following miscarriage or ectopic pregnancy: a prospective cohort study. BMJ Open. 2016 Nov 2;6(11):e011864. doi: 10.1136/bmjopen-2016-011864.

    PMID: 27807081BACKGROUND

  • Guha S, Van Belle V, Bottomley C, Preisler J, Vathanan V, Sayasneh A, Stalder C, Timmerman D, Bourne T. External validation of models and simple scoring systems to predict miscarriage in intrauterine pregnancies of uncertain viability. Hum Reprod. 2013 Nov;28(11):2905-11. doi: 10.1093/humrep/det342. Epub 2013 Aug 26.

    PMID: 23980057BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Cecilia Bottomley, MRCOG MD

    Chelsea and Westminster NHS Foundation Trust

    STUDY CHAIR

  • Kim K Lawson, MBChB

    Chelsea and Westminster NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim K Lawson, MBChB

CONTACT

02033155070kimlawson@nhs.net

Cecilia Bottomley, MRCOG MD

CONTACT

02033155070cecilia.bottomley@chelwest.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 29, 2017

Study Start

March 1, 2018

Primary Completion

September 1, 2019

Study Completion

March 1, 2020

Last Updated

March 7, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share