Psychological Impact of Pregnancy of Unknown Location

NCT04739956 | Completed Results

• 1 other identifier: 19QC5631
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the psychological impact of pregnancy of unknown location (PUL) classification pending a final diagnosis.

Conditions

Pregnancy of Unknown Location; Ectopic Pregnancy; Anxiety

Keywords

Pregnancy of unknown location; PUL; Ectopic pregnancy; Anxiety

Outcome Measures

Primary Outcomes (1)

• Psychological Morbidity

  Psychological morbidity will be assessed using the Hospital Anxiety and Depression Scale on time of PUL classification, 48 hours from PUL classification and following final diagnosis and management. For both Anxiety and Depression, participants can score anywhere from 0 to 21. Score of 11 and above indicate moderate to severe anxiety and depression.

  0 hours, 48 hours and point of diagnosis (within 2 wees)

Study Arms (2)

Patient: point of care (POC) result not shared

Patients in this phase of the study will not be provided with the POC BhCG result. They will await the laboratory result. Simultaneously we will ascertain reliability of POC in clinical practice during this time.

Other: The Hospital and Anxiety Depression Scale; Other: Point of care testing (POCT)

Patient: point of care (POC) result shared

Patients in this phase will be informed of the POC test result, which will reduce the time to which they receive the result. Prior to transfer to this phase, correlation between POC and laboratory BhCG levels will be calculated in order to confirm its reliability by creating a correlation curve using the data.

Other: The Hospital and Anxiety Depression Scale; Other: Point of care testing (POCT)

Interventions

The Hospital and Anxiety Depression Scale OTHER

Patients and partners will be asked to complete the questionnaire at three time points: 1) On classification of PUL at time zero once blood is taken, 2) at the 48-hour time point after blood is taken (if 48 hour bloods are required for the patient); and 3) after definitive diagnosis and management.

Patient: point of care (POC) result not shared; Patient: point of care (POC) result shared

Point of care testing (POCT) OTHER

Patients will have 1ml sample of blood taken for POCT at two time points: 1) On classification of PUL at time zero at the same time as when routine blood samples taken; and 2) at the 48-hour time point at the same time as when routine blood samples are taken (if 48 hour bloods are required).

Patient: point of care (POC) result not shared; Patient: point of care (POC) result shared

Eligibility Criteria

• Age: 18 Years - 50 Years
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women attending the Early Pregnancy Unit in the first trimester (up to 14 weeks gestation) with a pregnancy of unknown who are over 18 years old and are able to give consent.

You may qualify if:

• Pregnant women attending the Early Pregnancy Unit in the first trimester (up to 14 weeks gestation) with a pregnancy of unknown who are over 18 years old and are able to give consent.

You may not qualify if:

• Presence diagnosed with cancer
• The presence of an acute medical condition
• Patients/partners aged less than 18 years
• Patients or partners who cannot give fully informed study consent (language or learning impairment)
• Presence of a viable intrauterine pregnancy, ectopic pregnancy and miscarriage.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• Kyriacou C, Yang W, Kapur S, Maheetharan S, Pikovsky M, Parker N, Barcroft J, Bobdiwala S, Sur S, Stalder C, Gould D, Ofili-Yebovi D, Day A, Unsworth N, Wilkes EH, Tan T, Bourne T. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices. Clin Chem Lab Med. 2023 Oct 30;62(4):664-673. doi: 10.1515/cclm-2023-0703. Print 2024 Mar 25.

  PMID: 37886834 DERIVED

MeSH Terms

Conditions

Pregnancy, Ectopic; Anxiety Disorders

Interventions

Point-of-Care Testing

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Point-of-Care Systems; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr Margaret Pikovsky
• Organization: Imperial College Healthcare NHS Trust

m.pikovsky@nhs.net

+447870276373

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: December 2, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2025-01

Locations

GB (1)