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CompletedNCT05479786Updated Aug 2, 2022

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

An observational study in Ectopic Pregnancy, sponsored by University of Palermo. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by University of Palermo · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
312
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Ectopic Pregnancy

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Keywords

  • Ectopic pregnancy
  • Expectant management
  • Pregnancy outcome
  • Salpingectomy
  • Salpingostomy
03

In context

Pregnancy, Ectopic

83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's enrollment of 312 is above the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.

Browse Pregnancy, Ectopic studies →

Lead sponsor

University of Palermo is the lead sponsor of 145 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
312 participants (actual)
Patient registry
No

Groups and cohorts

  • Ectopic pregnancy

    Women with diagnosed tubal ectopic pregnancy

    Other: Expectant management · Procedure: Salpingectomy · Procedure: Salpingostomy

Interventions

  • OtherExpectant management

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

  • ProcedureSalpingectomy

    Removal of the affected Fallopian tube by laparoscopy

  • ProcedureSalpingostomy

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

06

What researchers measure

Primary outcomes

  1. Clinical pregnancy rate

    Presence of a gestational sac under ultrasonography

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

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2012 to primary completion in Dec 2020, 107 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2022
First posted
Jul 29, 2022
StartActual
Jan 1, 2012
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2020
Last update
Aug 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05479786
Collaborators
University of Debrecen, Damascus University
Responsible party
Antonio Simone Laganà (Principal Investigator, University of Palermo) — Principal investigator
First posted
Jul 29, 2022
Start date
Jan 1, 2012
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Aug 2, 2022

Study contacts

Antonio Simone Laganà, M.D., Ph.D.
principal investigator · University of Palermo
Antoine Naem, M.D.
study chair · Damascus University
Péter Török, M.D.
study director · University of Debrecen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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