CompletedNot Applicable

Management of Pregnancies of Unknown Location (PUL)

Sweden609 participantsStarted 2018-02-22

Plain-language 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.

Who can participate

SexFEMALE

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Inclusion criteria

✓. Patients with a PUL
✓. Patients with mild or no symptoms
✓. Patients willing to be randomized
✓. First hCG value \<10,000 IU/L
✓. Patients with an interval between two hCG measurements of 44-56 h

Exclusion criteria

✕. Hemodynamically unstable patients
✕. Hemoperitoneum
✕. Patients not managed as outpatients during the course of the initial two hCG measurements
✕. Non-understanding of the oral or written study information

What they're measuring

Sensitivity

Timeframe: 1 month

Specificity

Timeframe: 1 month

Trial details

NCT IDNCT03461835

SponsorGöteborg University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Pregnancy, Ectopic trials