Hysteroscopy for Pregnancy of Unknown Location
- Conditions
- Pregnancy
- Interventions
- Device: hysteroscope
- Registration Number
- NCT02637739
- Lead Sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 30
- women with PUL
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pregnancy of unknown location hysteroscope 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
- Primary Outcome Measures
Name Time Method percentage of women with PUL waived from laparoscopic examination 2 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital
🇨🇳Taipei, Taiwan