Ectopic PregnancyNCT05479786
Reproductive Outcomes After a Previous Episode of Tubal Ectopic Pregnancy in Patients Managed Expectantly and Surgically
An observational study of Ectopic Pregnancy, run by University of Palermo.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Expectant management, Salpingectomy and Salpingostomy
- Type of treatment
- Surgery or procedure
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnancies of unknown location
- Other types of ectopic pregnancy
- Pelvic inflammatory disease
- Pelvic adhesions
- Intrauterine pathologies
- Pregnancies obtained after assisted-reproductive technologies (ART)
About this study
Official title: Evaluation of Reproductive Outcomes After Expectant or Surgical Management of a Previous Episode of Tubal Ectopic Pregnancy
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.
- Conditions
- Ectopic Pregnancy
- Being tested
- Expectant management, Salpingectomy, Salpingostomy
- Keywords
- Ectopic pregnancy, Expectant management, Pregnancy outcome, Salpingectomy, Salpingostomy
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectant managementOther
Follow-up with beta-HCG dosages and transvaginal ultrasound scans
SalpingectomyProcedure or surgery
Removal of the affected Fallopian tube by laparoscopy
SalpingostomyProcedure or surgery
Removal of the ectopic pregnancy from the Fallopian tube, without removing the whole Fallopian tube, by laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| Ectopic pregnancy | Women with diagnosed tubal ectopic pregnancy Receives: Other: Expectant management; Procedure: Salpingectomy; Procedure: Salpingostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Presence of a gestational sac under ultrasonography
Measured: Within one year after the previous episode of tubal ectopic pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Jan 2012
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Debrecen, Damascus University
- Responsible party
- Principal investigator, Antonio Simone Laganà, University of Palermo
- Investigators
- Antonio Simone Laganà, M.D., Ph.D., Principal investigator, University of PalermoAntoine Naem, M.D., Study chair, Damascus UniversityPéter Török, M.D., Study director, University of Debrecen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479786
- Sponsor's protocol ID
- ECTO-1
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reproductive Outcomes After Expectant or Surgical Management of a Previous Episode of Tubal Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT05479786
- Acronym / sponsor ID
- ECTO-1
- Conditions
- Ectopic Pregnancy
- Keywords
- Ectopic pregnancy, Expectant management, Pregnancy outcome, Salpingectomy, Salpingostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Collaborators
- University of Debrecen, Damascus University
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ectopic pregnancy | – | Other: Expectant management, Procedure: Salpingectomy, Procedure: SalpingostomyWomen with diagnosed tubal ectopic pregnancy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Pregnancies of unknown location
- Other types of ectopic pregnancy
- Pelvic inflammatory disease
- Pelvic adhesions
- Intrauterine pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expectant managementFollow-up with beta-HCG dosages and transvaginal ultrasound scans | Other | Ectopic pregnancy |
| SalpingectomyRemoval of the affected Fallopian tube by laparoscopy | Procedure or surgery | Ectopic pregnancy |
| SalpingostomyRemoval of the ectopic pregnancy from the Fallopian tube, without removing the whole Fallopian tube, by laparoscopy | Procedure or surgery | Ectopic pregnancy |
Primary outcome
Clinical pregnancy rate
Time frame: Within one year after the previous episode of tubal ectopic pregnancy
Presence of a gestational sac under ultrasonography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy, run by University of Palermo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: Within one year after the previous episode of tubal ectopic pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.