Hysteroscopy for Pregnancy of Unknown Location

Pregnancy Clinical Trial

Official title:

Office Hysteroscopy as a Diagnostic Tool of Pregnancy of Unknown Location

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02637739
• Other study ID #: SKH-8302-104_DR-18
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2015
• Last updated: January 6, 2016
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: Yu-Hung Lin, bachelor
• Phone: +886-2-28332211
• Email: M002179[@]ms.skh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• women with PUL

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• hysteroscope
Women of PUL with ß-hCG > 1000 IU/L or abnormal ß-hCG trend (increase < 66% or decrease < 15%) were offered HSC.

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of women with PUL waived from laparoscopic examination		2 weeks	No