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

Completed

• Conditions: Ectopic Pregnancy
• Interventions: Other: Expectant management; Procedure: Salpingectomy; Procedure: Salpingostomy

• Registration Number: NCT05479786
• Lead Sponsor: University of Palermo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-07
• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-26
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 312

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ectopic pregnancy	Salpingostomy	Women with diagnosed tubal ectopic pregnancy
Ectopic pregnancy	Expectant management	Women with diagnosed tubal ectopic pregnancy
Ectopic pregnancy	Salpingectomy	Women with diagnosed tubal ectopic pregnancy

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	Within one year after the previous episode of tubal ectopic pregnancy	Presence of a gestational sac under ultrasonography