Hysteroscopy for Pregnancy of Unknown Location | NCT02637739

Studies
Hysteroscopy for Pregnancy of Unknown Location

NCT02637739

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Status

Unknown status

Last Update Posted

Jan 7, 2016Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Pregnancy

Interventions

hysteroscope

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Dec 6, 2015

First Submission Date that Met QC Criteria

Dec 21, 2015

First Posted Date

Dec 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2016

Last Update Posted Date

Jan 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yu-Hung Lin, M.D., Shin Kong Wu Ho-Su Memorial HospitalPrincipal Investigator

Lead Sponsor

Shin Kong Wu Ho-Su Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
hysteroscope	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of women with PUL waived from laparoscopic examination		2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with PUL

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu-Hung Lin, bachelor	Contact	+886-2-28332211	3879	M002179@ms.skh.org.tw

Overall Officials

Name	Affiliation	Role
Gong-Jhe Wu	Shin Kong Wu Ho-Su Memorial Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital	Recruiting	Taipei		111	Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D020702	Hysteroscopes

Ancestor Terms

ID	Term
D019723	Endoscopes
D019719	Diagnostic Equipment
D004864	Equipment and Supplies
D013523	Surgical Equipment

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Browse Branches

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