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

NCT ID: NCT05479786

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 312 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2020-12-31

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.

Conditions

Ectopic Pregnancy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ectopic pregnancy

Women with diagnosed tubal ectopic pregnancy

Expectant management

Intervention Type: OTHER

Follow-up with beta-HCG dosages and transvaginal ultrasound scans

Salpingectomy

Intervention Type: PROCEDURE

Removal of the affected Fallopian tube by laparoscopy

Salpingostomy

Intervention Type: PROCEDURE

Removal of the ectopic pregnancy from the Fallopian tube, without removing the whole Fallopian tube, by laparoscopy

Interventions

Expectant management

Follow-up with beta-HCG dosages and transvaginal ultrasound scans

Intervention Type: OTHER

Salpingectomy

Removal of the affected Fallopian tube by laparoscopy

Intervention Type: PROCEDURE

Salpingostomy

Removal of the ectopic pregnancy from the Fallopian tube, without removing the whole Fallopian tube, by laparoscopy

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Debrecen

OTHER

Sponsor Role: collaborator

Damascus University

OTHER

Sponsor Role: collaborator

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Antonio Simone Laganà

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Simone Laganà, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Palermo

Antoine Naem, M.D.

Role: STUDY_CHAIR

Damascus University

Péter Török, M.D.

Role: STUDY_DIRECTOR

University of Debrecen

Other Identifiers

ECTO-1

Identifier Type: -

Identifier Source: org_study_id