Reproductive Outcomes After a Previous Episode of Tubal Ectopic Pregnancy in Patients Managed Expectantly and Surgically

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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