NCT02637739

Hysteroscopy for Pregnancy of Unknown Location

Office Hysteroscopy as a Diagnostic Tool of Pregnancy of Unknown Location

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy

Interventions

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

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-12-22
• Last updated: 2016-01-07

Locations

1 site across 1 country: Taiwan