Cornual PregnancyNCT03064594
Comparison of Laparoscopic Cornuostomy and Wedge Resection for Interstitial Pregnancy
An observational study of Cornual Pregnancy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This retrospective study is to find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cornual Pregnancy
- What is being tested?
- Cornual pregnancy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Feb 2017to 2 Nov 2018
- Phase
- Observational
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: the cases with cornual pregnancy
Who may be able to join
- All women with cornual pregnancy who were admitted to the Department of Obstetrics and Gynecology of the Far Eastern Memorial Hospital for laparoscopic surgeries between January 2008 and June 2016 were enrolled
Who cannot join
- The person who was pregnant at the time of the operation
- After receiving IVF course of treatment
- Patients with uterine horns undergoing open surgery
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
New Taipei City, Banqiao, 22060
About this study
This retrospective study is to find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome.
Read the detailed description
To find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome, the investigators compared the outcomes of laparoscopic wedge resection (LWR) and laparoscopic cornuostomy (LC) by the retrospective chart review.
- Conditions
- Cornual Pregnancy
- Being tested
- Cornual pregnancy
- Medical subject headings
- Pregnancy, Cornual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cornual pregnancyProcedure or surgery
we will get the information of operative time, blood loss and postoperative pregnancy and delivery rate.
| Study group | Role | What they receive |
|---|---|---|
| cornuostomy | cornuostomy Receives: Procedure: Cornual pregnancy | |
| wedge resection | wedge resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Comparison of pregnancy rates between the cornuostomy and wedge resection groups
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start9 Feb 2017
- Primary completion12 Oct 2017
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cornual 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064594
- Sponsor's protocol ID
- 105143-E
- Status last verified
- Feb 2019
- First submitted
- 9 Feb 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Cornuostomy and Wedge Resection for Interstitial Pregnancy
- ClinicalTrials.gov ID
- NCT03064594
- Acronym / sponsor ID
- 105143-E
- Conditions
- Cornual Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 27 Feb 2017 (actual)
- 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.
This retrospective study is to find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome.
Detailed description
To find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome, the investigators compared the outcomes of laparoscopic wedge resection (LWR) and laparoscopic cornuostomy (LC) by the retrospective chart review.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cornuostomy | – | Procedure: Cornual pregnancycornuostomy |
| wedge resection | – | –wedge resection |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the cases with cornual pregnancy
Key inclusion criteria (1 listed)
- All women with cornual pregnancy who were admitted to the Department of Obstetrics and Gynecology of the Far Eastern Memorial Hospital for laparoscopic surgeries between January 2008 and June 2016 were enrolled
Key exclusion criteria (3 listed)
- The person who was pregnant at the time of the operation
- After receiving IVF course of treatment
- Patients with uterine horns undergoing open surgery
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 |
|---|---|---|
| Cornual pregnancywe will get the information of operative time, blood loss and postoperative pregnancy and delivery rate. | Procedure or surgery | cornuostomy |
Primary outcome
pregnancy rate
Time frame: 9 years
Comparison of pregnancy rates between the cornuostomy and wedge resection groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cornual Pregnancy, run by Far Eastern 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 3 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: finished, as of the sponsor's last update on 15 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 9 years). 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 15 Feb 2019.