PregnancyNCT02637739
Hysteroscopy for Pregnancy of Unknown Location
A study testing hysteroscope in people with Pregnancy, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- hysteroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- women with PUL
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital
Taipei, 111
Yu-Hung Lin, MD, 886-2-28332211 ext. 3879, m002179@ms.skh.org.tw
Heng-Ju Chen, MD, 886-2-28332211 ext. 3879, m004983@ms.skh.org.tw
About this study
Official title: 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.
Read the 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
- Being tested
- hysteroscope
- Keywords
- hysteroscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopeDevice
Women of PUL with β-hCG > 1000 IU/L or abnormal β-hCG trend (increase < 66% or decrease < 15%) were offered HSC.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy of unknown location | Experimental | 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 Receives: Device: hysteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of women with PUL waived from laparoscopic examination
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Hung Lin, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Gong-Jhe Wu, Study director, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637739
- Sponsor's protocol ID
- SKH-8302-104_DR-18
- Status last verified
- Jan 2016
- First submitted
- 6 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office Hysteroscopy as a Diagnostic Tool of Pregnancy of Unknown Location
- ClinicalTrials.gov ID
- NCT02637739
- Acronym / sponsor ID
- SKH-8302-104_DR-18
- Conditions
- Pregnancy
- Keywords
- hysteroscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy of unknown location | Experimental | Device: hysteroscopepregnant women of at least 5 weeks by last menstrual period and transvaginal ultrasound did not revealed intra-uterine pregnancy or ectopic pregnancy Intervention: hysteroscope |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- women with PUL
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hysteroscopeWomen of PUL with β-hCG > 1000 IU/L or abnormal β-hCG trend (increase < 66% or decrease < 15%) were offered HSC. | Device | Pregnancy of unknown location |
Primary outcome
percentage of women with PUL waived from laparoscopic examination
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gong-Jhe Wu study director
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hysteroscope in people with Pregnancy, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Hung Lin, bachelor (+886-2-28332211 ext. 3879, M002179@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of women with PUL waived from laparoscopic examination (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.