Clinical trial NCT05479786: Reproductive Outcomes After a Previous Episode of Tubal Ectopic Pregnancy in Patients Managed Expectantly and Surgically
Official title: Evaluation of Reproductive Outcomes After Expectant or Surgical Management of a Previous Episode of Tubal Ectopic Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectopic Pregnancy
Keywords: Ectopic pregnancy
Expectant management
Pregnancy outcome
Salpingectomy
Salpingostomy
Lead sponsor: University of Palermo
Sponsor class: OTHER
Collaborators: name: University of Debrecen
name: Damascus University
First posted: 2022-07-29
Enrollment: 312
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: Within one year after the previous episode of tubal ectopic pregnancy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Palermo
name: Antonio Simone Laganà, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Damascus University
name: Antoine Naem, M.D.
role: STUDY_CHAIR
affiliation: University of Debrecen
name: Péter Török, M.D.
role: STUDY_DIRECTOR
References: