NCT04738370

Brief Summary

To further develop the patient care pathway for women classified with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 8, 2014

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

10.1 years

First QC Date

February 1, 2021

Last Update Submit

March 31, 2022

Conditions

Pregnancy of Unknown LocationEctopic PregnancyEarly PregnancyEarly Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

  • PUL outcome prediction

    The number of PUL patients correctly categorised as 'low risk' or 'high risk' based on the new logistical regression model

    7 years

Secondary Outcomes (7)

  • Urinary BhCG and PUL

    7 years

  • Urine BhCG and Ectopic pregnancy

    7 years

  • Plasma and Serum and PUL

    7 years

  • Plasma and Serum and Ectopic pregnancy

    7 years

  • BhCG timing

    7 years

  • +2 more secondary outcomes

Study Arms (2)

Pregnancy of unknown location

Patients will be approached for recruitment following PUL classification. Sample collection at time of classification +/- 48 hours later, timed for when bloods are taken as part of routine clinical practice +/- at any time patient attends for clinically indicated blood samples.

Other: Sample collection

Ectopic Pregnancy

Patients will be approached for recruitment following Ectopic Pregnancy diagnosis. Ectopic pregnancies that are recruited as PUL do not need to be re-approached as they are already part of the study. Sample collection at time of diagnosis when bloods are taken as part of routine clinical practice +/- at any time patient attends for clinically indicated blood samples.

Other: Sample collection

Interventions

Sample collectionOTHER

Bloods +/- urine +/- vaginal swabs taken

Ectopic PregnancyPregnancy of unknown location

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women attending the Early Pregnancy Unit (EPU) within a hospital in the first trimester (up to 14 weeks gestation) with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan between the ages of 18 and 50 years.

You may qualify if:

  • Patients attending the Early Pregnancy Unit in the first trimester of pregnancy (≤14 weeks gestation) aged between 18-50 years old and categorized as having a PUL or ectopic pregnancy

You may not qualify if:

  • Younger than 18 years of age
  • 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
  • Viable intrauterine pregnancy (the presence of a fetal pole with a fetal heartbeat within the uterine cavity)
  • Miscarriage
  • Presence of an acute medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

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: 37886834DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (plasma and serum - plasma can assess for microRNA) +/- urine samples +/- vaginal swabs

MeSH Terms

Conditions

Pregnancy, EctopicAbortion, Spontaneous

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Tom Bourne, MBBS, PhD, MRCOG

CONTACT

0044 203 313 5131t.bourne@ic.ac.uk

Christopher Kyriacou, MBBS, BSc

CONTACT

0044 203 313 5131Christopher.kyriacou@nhs.net

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 4, 2021

Study Start

December 8, 2014

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations

GB(1)