Ectopic Pregnancy Clinical Trial
Official title:
Clinical Outcome of Laparoscopic Tubal Preservation Surgery for Ectopic Pregnancy
NCT number | NCT03253588 |
Other study ID # | 106002-E |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 21, 2017 |
Est. completion date | October 15, 2017 |
Verified date | July 2019 |
Source | Far Eastern Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy. We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the fertility outcome of the patients, as well as to identify the factors predicting the presence of persistent ectopic pregnancy after the surgery.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 15, 2017 |
Est. primary completion date | September 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility |
Inclusion Criteria: - women who had laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy) for ectopic pregnancy between January 2009 and November 2016 Exclusion Criteria: - women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial, ovary, abdomen) |
Country | Name | City | State |
---|---|---|---|
Taiwan | Far Eastern Memorial Hospital | Taipei | New Taipei City |
Lead Sponsor | Collaborator |
---|---|
Far Eastern Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | peri- and post-operative parameters | success rate of tubal preservation surgery (defined by postoperative serum bcg <5 IU/mL), postoperative complications (number of women who had adverse surgical outcome such as bladder injury, bowel injury, massive bleeding), pregnancy outcome (number of women who conceived successfully following the intervention) | between January 2009 and November 2016 | |
Secondary | factors affecting the surgical success rate | relationship between patient's baseline characteristics and rate of persistent ectopic pregnancy (unvariate and multivariate analysis) | between January 2009 and November 2016 |
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