Hysteroscopy for Pregnancy of Unknown Location

NCT ID: NCT02637739

Last Updated: 2016-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pregnancy of unknown location

pregnant women of at least 5 weeks by last menstrual period and transvaginal ultrasound did not revealed intra-uterine pregnancy or ectopic pregnancy Intervention: hysteroscope

Group Type EXPERIMENTAL

hysteroscope

Intervention Type DEVICE

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

Interventions

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hysteroscope

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* women with PUL
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu-Hung Lin

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gong-Jhe Wu

Role: STUDY_DIRECTOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

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Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Hung Lin, bachelor

Role: CONTACT

+886-2-28332211 ext. 3879

Facility Contacts

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Yu-Hung Lin, MD

Role: primary

886-2-28332211 ext. 3879

Heng-Ju Chen, MD

Role: backup

886-2-28332211 ext. 3879

Other Identifiers

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SKH-8302-104_DR-18

Identifier Type: -

Identifier Source: org_study_id

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