NCT02637739

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

2.9 years

First QC Date

December 6, 2015

Last Update Submit

January 6, 2016

Conditions

Pregnancy

Keywords

hysteroscope

Outcome Measures

Primary Outcomes (1)

  • percentage of women with PUL waived from laparoscopic examination

    2 weeks

Study Arms (1)

Pregnancy of unknown location

EXPERIMENTAL

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

Device: hysteroscope

Interventions

hysteroscopeDEVICE

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

Pregnancy of unknown location

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • women with PUL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, 111, Taiwan

RECRUITING

MeSH Terms

Interventions

Hysteroscopes

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Gong-Jhe Wu

    Shin Kong Wu Ho-Su Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Yu-Hung Lin, bachelor

CONTACT

+886-2-28332211M002179@ms.skh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 6, 2015

First Posted

December 22, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

TW(1)