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

NCT05479786 | Completed

• 1 other identifier: ECTO-1
• Study Type: observational
• Target: 312
• Locations: 0 countries
• Sites: N/A

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

Keywords

Ectopic pregnancy; Expectant management; Pregnancy outcome; Salpingectomy; Salpingostomy

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Presence of a gestational sac under ultrasonography

  Within one year after the previous episode of tubal ectopic pregnancy

Study Arms (1)

Ectopic pregnancy

Women with diagnosed tubal ectopic pregnancy

Other: Expectant management; Procedure: Salpingectomy; Procedure: Salpingostomy

Interventions

Expectant management OTHER

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

Ectopic pregnancy

Salpingectomy PROCEDURE

Removal of the affected Fallopian tube by laparoscopy

Ectopic pregnancy

Salpingostomy PROCEDURE

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

Ectopic pregnancy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with either surgically-confirmed tubal ectopic pregnancy or a diagnosis of tubal ectopic pregnancy based on a positive beta-HCG serum measurement with the visualization of an adnexal mass resembling a tubal gestational sac and an empty uterine cavity upon transvaginal ultrasonographic scan.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancies of unknown location
• Other types of ectopic pregnancy
• Pelvic inflammatory disease
• Pelvic adhesions
• Intrauterine pathologies
• Pregnancies obtained after assisted-reproductive technologies (ART)

Sponsors & Collaborators

• University of Palermo: lead
• University of Debrecen: collaborator
• Damascus University: collaborator

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Watchful Waiting; Salpingectomy; Salpingostomy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Anastomosis, Surgical

Study Officials

• Antonio Simone Laganà, M.D., Ph.D.

  University of Palermo

  PRINCIPAL INVESTIGATOR

• Antoine Naem, M.D.

  Damascus University

  STUDY CHAIR

• Péter Török, M.D.

  University of Debrecen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: January 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share