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OpenTrials
Completed

NCT Number: NCT05479786

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Expectant Management

Other

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

Salpingectomy

Procedure

Removal of the affected Fallopian tube by laparoscopy

Salpingostomy

Procedure

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

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: Within one year after the previous episode of tubal ectopic pregnancy

    Presence of a gestational sac under ultrasonography

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Collaborators

  • Damascus University
  • University of Debrecen

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2022
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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