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Probability of viability estimation and anxiety levels in women with small seemingly empty gestational sacs

A prospective randomised interventional study of a test to predict viability in early pregnancy: psychological effect and patient acceptability

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76836892
Enrollment
346
Registered
2013-01-25
Start date
2012-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early pregnancy Pregnancy and Childbirth

Interventions

Patients will be randomised in to one of 2 groups. Group 1 will be randomised to having probability of viability score and group 2 no score. Group 1 will have bloods taken for progesterone. Contact

Sponsors

King's College Hospital NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women (16-40 years) with a positive urine pregnancy test (Clearview HCG II ) 2. Who have conceived spontaneously and have a single intrauterine gestational sac of <20mm mean gestational sac diameter (GSD) with no visible embryo on their first ultrasound scan. A yolk sac is not considered to be a visible embryo so these women will be included.

Exclusion criteria

Exclusion criteria: 1. Assisted conception 2. Multiple pregnancy 3. Use of exogenous progesterone 4. Women who decline to participate 5. Women who intend to terminate the pregnancy 6. Women receiving treatment or investigation for psychiatric disorder 7. Non-English speaking [Hospital Anxiety and Depression Scale (HADS) not validated in other languages]

Design outcomes

Primary

MeasureTime frame
Difference in HADS at 7 days between cases and controls.

Secondary

MeasureTime frame
Prior to the re-scan 14 days from the initial scan group 1 will be asked two questions in order to establish if the patient found the test helpful. 1. Was it useful to receive the test result? 2. Would they choose to have the test again if they were in a similar position?

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026