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

Ectopic Pregnancy Clinical Trial

Official title:

Evaluation of Reproductive Outcomes After Expectant or Surgical Management of a Previous Episode of Tubal Ectopic Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05479786
• Other study ID #: ECTO-1
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2022
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Other:
• Expectant management
Follow-up with beta-HCG dosages and transvaginal ultrasound scans

Procedure:
• Salpingectomy
Removal of the affected Fallopian tube by laparoscopy
• Salpingostomy
Removal of the ectopic pregnancy from the Fallopian tube, without removing the whole Fallopian tube, by laparoscopy

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Palermo	Damascus University, University of Debrecen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Presence of a gestational sac under ultrasonography	Within one year after the previous episode of tubal ectopic pregnancy