Brief Title
Reproductive Outcomes After a Previous Episode of Tubal Ectopic Pregnancy in Patients Managed Expectantly and Surgically
Official Title
Evaluation of Reproductive Outcomes After Expectant or Surgical Management of a Previous Episode of Tubal Ectopic Pregnancy
Brief Summary
Although ectopic pregnancy was considered a leading cause of first-trimester maternal mortalities, current technological improvements allowed early diagnosis and opened a door for applying less invasive approaches. A tubal pregnancy could be managed either expectantly, medically, or surgically. The expectant management of ectopic pregnancy relies on the fact that a considerable proportion of ectopic gestations terminate by spontaneous tubal abortion. This approach is usually kept for stable cases with a small gestational sac and low beta-human chorionic gonadotropin (beta-HCG) serum levels. For hemodynamically unstable patients, higher levels of beta-HCG, and larger gestational sacs, surgery is often considered as the treatment of choice (16). Considering this background, the study aims to analyze the subsequent natural reproductive outcomes of patients that had a previous tubal ectopic pregnancy and were managed either expectantly or surgically. Moreover, it amis to determine the factors that could influence the fertility potential of these patients in each treatment group.
Study Type
Observational
Primary Outcome
Clinical pregnancy rate
Condition
Ectopic Pregnancy
Intervention
Expectant management
Study Arms / Comparison Groups
Ectopic pregnancy
Description: Women with diagnosed tubal ectopic pregnancy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
312
Start Date
January 1, 2012
Completion Date
December 31, 2020
Primary Completion Date
December 31, 2020
Eligibility Criteria
Inclusion Criteria: - Women with one episode of tubal ectopic pregnancy, treated by expectant management, salpingectomy, or salpingostomy; - For patients treated surgically, only patients with at least one patent Fallopian tube confirmed via postoperative hysterosalpingography were included in the analysis. Exclusion Criteria: - Pregnancies of unknown location - Other types of ectopic pregnancy - Pelvic inflammatory disease - Pelvic adhesions - Intrauterine pathologies - Pregnancies obtained after assisted-reproductive technologies (ART)
Gender
Female
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
No
Contacts
Antonio Simone Laganà, M.D., Ph.D., ,
Administrative Informations
NCT ID
NCT05479786
Organization ID
ECTO-1
Responsible Party
Principal Investigator
Study Sponsor
University of Palermo
Collaborators
University of Debrecen
Study Sponsor
Antonio Simone Laganà, M.D., Ph.D., Principal Investigator, University of Palermo
Verification Date
July 2022