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Management of Pregnancies of Unknown Location (PUL)

NCT03461835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 609

Last updated 2025-04-06

No results posted yet for this study

Summary

In a randomized multicenter trial the investigators want to compare the ability of two hCG-based models in correctly classifying EPs as high risk among PULs and correctly classifying IUPs and failed PULs as low risk after two hCG measurements.

After the classification of PULs into high or low risk of EP, the clinical management will be the same within each risk group (high and low) regardless of randomization group (which model classified the patients). The clinical management will be according to the management protocol published in a NICE guideline.

Conditions

  • Pregnancy, Ectopic
  • Pregnancy, High Risk
  • Pregnancy Early

Interventions

DIAGNOSTIC_TEST

Risk classification of PUL by M4

High or low risk of being an ectopic pregnancy

DIAGNOSTIC_TEST

Risk classification of PUL by NICE

High or low risk of being an ectopic pregnancy

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Annika Strandell, Ass.prof. · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2024-08-30
Completion
2024-12-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461835 on ClinicalTrials.gov