Assessment of Biomarkers in Pregnancy on Unknown Location & Ectopic

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

Purpose and design-There is a need for the patient care pathway to evolve in order to aid and improve the diagnosis and management of women with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP). There is potential for this to be achieved by the incorporation of a statistical model that uses one or more novel markers identified by this study. Recruitment-1000 patients. Inclusion: Patients attending the Early Pregnancy Unit (EPU) in the first trimester with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan between the ages of 18-50 years. Exclusion: Patients diagnosed with cancer, presence of acute medical condition, patients aged less than 18 years, patients who cannot give fully informed study consent. Consent - Posters will advertise the study. Patients in EPU will be invited to the study by a member of the clinical care team. Written consent will be required. Confidentiality - The Chief Investigator will preserve the confidentiality of participants taking part in the study and is registered under the Data Protection Act. Patient consent forms will be stored securely within the study file. All patient identifiable information, where required, will be stored electronically on National Health Service (NHS) approved computers, accessible only by personnel involved in the study via password. Conflict of interest - None involved in the study have a conflict of interest. Dissemination of results - No patient identifiable information will be included in the research report or publication. Anonymised results will be disseminated to scientific community by means of publication in peer-reviewed literature and presented at national and international meetings. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04738370
Study type	Observational
Source	Imperial College London
Contact	Tom Bourne, MBBS, PhD, MRCOG
Phone	0044 203 313 5131
Email	t.bourne@ic.ac.uk
Status	Recruiting
Phase
Start date	December 8, 2014
Completion date	December 31, 2024

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See also
Status	Clinical Trial	Phase
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Not yet recruiting	`NCT05039853` - Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task	N/A
Completed	`NCT00194207` - Risk Factors of Ectopic Pregnancy	N/A
Completed	`NCT00827970` - Randomized Population-Based Study on Chlamydia Trachomatis Screening	N/A
Recruiting	`NCT05374720` - Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy	N/A
Completed	`NCT03894735` - Vitamin D in Ectopic Pregnancies
Recruiting	`NCT01860690` - BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success	Phase 4
Recruiting	`NCT04176549` - Assessment of Biomarkers in Ectopic Pregnancy
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Not yet recruiting	`NCT04308343` - The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy	N/A
Recruiting	`NCT06354439` - Use of Letrozole for Ectopic Pregnancy	Phase 4
Not yet recruiting	`NCT06300333` - Treatment of Ectopic Pregnancy by Low Dose of Methotrexate
Completed	`NCT00194272` - Two-Dose Methotrexate for Ectopic Pregnancy	Phase 3
Enrolling by invitation	`NCT03579550` - Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus	N/A
Completed	`NCT05446012` - Relationship Between Ectopic Pregnancy and Thyroid Disorders
Completed	`NCT00194168` - Ectopic Pregnancy Biomarkers	N/A
Completed	`NCT02152696` - Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location	Phase 3
Not yet recruiting	`NCT04975984` - Expectant Management of Ectopic Pregnancy

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy — ABPEP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms