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

• Sponsor: University of Palermo (Other)
• Overall Status: Completed
• CT.gov ID: NCT05479786
• Collaborator: University of Debrecen (Other), Damascus University (Other)
• Enrollment: 312
• Actual Duration (Months): 108

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ectopic Pregnancy	Other: Expectant management; Procedure: Salpingectomy; Procedure: Salpingostomy

Study Design

• Study Type: Observational
• Actual Enrollment: 312 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Evaluation of Reproductive Outcomes After Expectant or Surgical Management of a Previous Episode of Tubal Ectopic Pregnancy
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Ectopic pregnancy Women with diagnosed tubal ectopic pregnancy	Other: Expectant management; Follow-up with beta-HCG dosages and transvaginal ultrasound scans; Procedure: Salpingectomy; Removal of the affected Fallopian tube by laparoscopy; Procedure: Salpingostomy; Removal of the ectopic pregnancy from the Fallopian tube, without removing the whole Fallopian tube, by laparoscopy

Outcome Measures

Primary Outcome Measures

1. Clinical pregnancy rate [Within one year after the previous episode of tubal ectopic pregnancy]

   Presence of a gestational sac under ultrasonography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Palermo
• University of Debrecen
• Damascus University

Investigators

• Principal Investigator: Antonio Simone Laganà, M.D., Ph.D., University of Palermo
• Study Chair: Antoine Naem, M.D., Damascus University
• Study Director: Péter Török, M.D., University of Debrecen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonio Simone Laganà, Principal Investigator, University of Palermo
• ClinicalTrials.gov Identifier: NCT05479786
• Other Study ID Numbers: ECTO-1
• First Posted: Jul 29, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Antonio Simone Laganà, Principal Investigator, University of Palermo: Ectopic pregnancy; Expectant management; Pregnancy outcome; Salpingectomy; Salpingostomy
• Additional relevant MeSH terms: Pregnancy, Ectopic; Pregnancy, Tubal; Cardiac Complexes, Premature

Study Results

No Results Posted as of Aug 2, 2022