Hysteroscopy for Pregnancy of Unknown Location

Status Recruiting

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Pregnancy

Clinical Trial Details

NCT number	NCT02637739
Study type	Interventional
Source	Shin Kong Wu Ho-Su Memorial Hospital
Contact	Yu-Hung Lin, bachelor
Phone	+886-2-28332211
Email	M002179@ms.skh.org.tw
Status	Recruiting
Phase	N/A
Start date	January 2014
Completion date	December 2016

View Details

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