Probability of viability estimation and anxiety levels in women with small seemingly empty gestational sacs
Not Applicable
Completed
- Conditions
- Early pregnancyPregnancy and Childbirth
- Registration Number
- ISRCTN76836892
- Lead Sponsor
- King's College Hospital NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 346
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
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]
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in HADS at 7 days between cases and controls.
- Secondary Outcome Measures
Name Time Method 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.<br>1. Was it useful to receive the test result?<br>2. Would they choose to have the test again if they were in a similar position?