Hysteroscopy for Pregnancy of Unknown Location

Office Hysteroscopy as a Diagnostic Tool of Pregnancy of Unknown Location

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy
• Intervention / Treatment: Device: hysteroscope

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Hung Lin, bachelor; Phone Number: 3879 +886-2-28332211; Email: M002179@ms.skh.org.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 111
    • Recruiting
    • Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital
    • Contact: Yu-Hung Lin, MD; Phone Number: 3879 886-2-28332211; Email: m002179@ms.skh.org.tw
    • Contact: Heng-Ju Chen, MD; Phone Number: 3879 886-2-28332211; Email: m004983@ms.skh.org.tw
    • Principal Investigator: Yu-Hung Lin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women with PUL

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: hysteroscope; Women of PUL with β-hCG > 1000 IU/L or abnormal β-hCG trend (increase < 66% or decrease < 15%) were offered HSC.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Investigators: Study Director: Gong-Jhe Wu, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Estimate): January 7, 2016
• Last Update Submitted That Met QC Criteria: January 6, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: hysteroscope
• Other Study ID Numbers: SKH-8302-104_DR-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No