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Hysteroscopy for Pregnancy of Unknown Location

Office Hysteroscopy as a Diagnostic Tool of Pregnancy of Unknown Location

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02637739
Enrollment
30
Registered
2015-12-22
Start date
2014-01-31
Completion date
2016-12-31
Last updated
2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

hysteroscope

Brief summary

About 10% of early pregnancies can not be visualized by transvaginal ultrasound (TVU) on first visit and are classified as pregnancy of unknown location (PUL). The etiology includes ongoing intra-uterine pregnancy, failing pregnancy, or ectopic pregnancy. Early diagnosis of ectopic pregnancy is important because it allows conservative treatment. Serum β-hCG, D&C, and laparoscopy are routinely used as diagnostic methods. The purpose of the study is to evaluate if the less invasive office hysteroscopy (HSC) can help diagnose PUL.

Detailed description

If TVU showed no evidence of intra-uterine and extra-uterine pregnancy, a blood test for β-hCG was done. If β-hCG was \< 1000 IU/L, the woman was followed with β-hCG 2 days later. Women with β-hCG \> 1000 IU/L or abnormal β-hCG trend (increase \< 66% or decrease \< 15%) were offered HSC. If gestational tissues were visualized, ectopic pregnancy was ruled out. Otherwise, the tentative diagnosis was ectopic pregnancy.

Interventions

Women of PUL with β-hCG \> 1000 IU/L or abnormal β-hCG trend (increase \< 66% or decrease \< 15%) were offered HSC.

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* women with PUL

Design outcomes

Primary

MeasureTime frame
percentage of women with PUL waived from laparoscopic examination2 weeks

Countries

Taiwan

Contacts

Primary ContactYu-Hung Lin, bachelor
M002179@ms.skh.org.tw+886-2-28332211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026