NCT04176549

Brief Summary

To further develop a patient care pathway (incorporating a statistical model which uses the values of biomarkers) in routine clinical practice that will aid the diagnosis and management of women with an ectopic pregnancy.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

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

November 18, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

6.1 years

First QC Date

November 20, 2019

Last Update Submit

July 6, 2022

Conditions

Ectopic Pregnancy

Keywords

Ectopic PregnancyBiomarker

Outcome Measures

Primary Outcomes (1)

  • Novel biomarkers for Ectopic Pregnancy prediction and diagnosis

    Identification of microRNA and microbiome markers identified in blood, urine, swabs, fallopian tubes, peritoneal washings and trophoblastic tissue that have predictive value in identifying ectopic pregnancies as well as high and low risk pregnancy of unknown location. microRNA will be assessed using blood and trophoblast using cell free profiling assays and quantitative reverse transcription polymerase chain reaction and microbiome will be assessed using Illumina microbiome genomic sequencing.

    3 years

Secondary Outcomes (2)

  • microRNA as a biomarker

    3 years

  • Microbiome as a biomarker

    3 years

Study Arms (3)

Ectopic Pregnancy

Patients diagnosed with ectopic pregnancy Samples collected: Plasma, Serum, Urine, Oral swab, Vaginal Swab If surgery required for tubal ectopic: Fallopian tube, peritoneal washing, trophoblast

Other: Management of Ectopic Pregnancy

Surgical termination of pregnancy

Patients undergoing elective surgical termination of pregnancy Samples collected: Plasma, Serum, Urine, Oral swab Vaginal swab, Trophoblast

Other: Management of termination of pregnancy

Elective hysterectomy and salpingo-oophorectomy

Patients undergoing elective hysterectomy and salpingo-oophorectomy Samples collected: Fallopian tube, peritoneal washing

Other: Elective management of gynaecology patients

Interventions

Management of Ectopic PregnancyOTHER

Expectant, Medical or Surgical management of Ectopic Pregnancy

Ectopic Pregnancy
Management of termination of pregnancyOTHER

Surgical termination of pregnancy

Surgical termination of pregnancy
Elective management of gynaecology patientsOTHER

Elective hysterectomy and salpingo-oophorectomy

Elective hysterectomy and salpingo-oophorectomy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability 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. * Women attending the gynaecology unit for a surgical termination of pregnancy or for a salpingo-oophorectomy.

You may qualify if:

  • Patients attending the Early Pregnancy Unit (EPU) 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.
  • Patients attending the gynaecology unit for a surgical termination of pregnancy or for a salpingo-oophorectomy.

You may not qualify if:

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

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 (5)

  • Bobdiwala S, Al-Memar M, Farren J, Bourne T. Factors to consider in pregnancy of unknown location. Womens Health (Lond). 2017 Aug;13(2):27-33. doi: 10.1177/1745505717709677. Epub 2017 Jun 29.

    PMID: 28660799BACKGROUND

  • Senapati S, Barnhart KT. Biomarkers for ectopic pregnancy and pregnancy of unknown location. Fertil Steril. 2013 Mar 15;99(4):1107-16. doi: 10.1016/j.fertnstert.2012.11.038. Epub 2013 Jan 3.

    PMID: 23290746BACKGROUND

  • Van Calster B, Bobdiwala S, Guha S, Van Hoorde K, Al-Memar M, Harvey R, Farren J, Kirk E, Condous G, Sur S, Stalder C, Timmerman D, Bourne T. Managing pregnancy of unknown location based on initial serum progesterone and serial serum hCG levels: development and validation of a two-step triage protocol. Ultrasound Obstet Gynecol. 2016 Nov;48(5):642-649. doi: 10.1002/uog.15864. Epub 2016 Oct 9.

    PMID: 26776599BACKGROUND

  • Bobdiwala S, Christodoulou E, Farren J, Mitchell-Jones N, Kyriacou C, Al-Memar M, Ayim F, Chohan B, Kirk E, Abughazza O, Guruwadahyarhalli B, Guha S, Vathanan V, Bottomley C, Gould D, Stalder C, Timmerman D, van Calster B, Bourne T. Triaging women with pregnancy of unknown location using two-step protocol including M6 model: clinical implementation study. Ultrasound Obstet Gynecol. 2020 Jan;55(1):105-114. doi: 10.1002/uog.20420.

    PMID: 31385381BACKGROUND

  • Cook J, Bennett PR, Kim SH, Teoh TG, Sykes L, Kindinger LM, Garrett A, Binkhamis R, MacIntyre DA, Terzidou V. First Trimester Circulating MicroRNA Biomarkers Predictive of Subsequent Preterm Delivery and Cervical Shortening. Sci Rep. 2019 Apr 10;9(1):5861. doi: 10.1038/s41598-019-42166-1.

    PMID: 30971726BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples Serum samples Urine samples Oral swabs Vaginal swabs Fallopian tube samples Peritoneal washing samples Trophoblast tissue samples

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Tom Bourne, MBBS, PhD, MRCOG

    Imperial College London

    PRINCIPAL INVESTIGATOR

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

November 20, 2019

First Posted

November 25, 2019

Study Start

November 18, 2019

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

GB(1)