EndometriosisNCT03354793
Endometriosis and Risk of Obstetric Complications
An observational study of Endometriosis and Pregnancy Complications, run by Endometriosis Treatment Italian Club.
Trial summary
The aim of this study is to compare the rate of obstetric complications at first spontaneous pregnancy among women with endometriosis, with the rate of obstetric complications at first spontaneous pregnancy among women without endometriosis Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Endometriosis, Pregnancy Complications
- What is being tested?
- Survey on first pregnancy after endometriosis diagnosis and Survey on first pregnancy
- How many people
- 844 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 4 Oct 2017
- 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 30 to 50 years
- Women only
- Adult
Study population: All continuous women attending endometriosis clinics or undergoing a routine gynecological examination matching the inclusion criteria
Who may be able to join
- 30 to 50 years old women with at least one previous spontaneous pregnancy > 12 weeks with surgical or clinical/sonographic diagnosis of endometriosis or in whom surgical or clinical/sonographic evaluation ruled out endometriosis
Who cannot join
- Pregnancy achieved by assisted reproductive techniques
- Pregnancy terminated before 12 gestational weeks
- Twin pregnancy
- Preexisting hypertension
- Lupus like anti-coagulant
- Non corrected uterine malformation
- Recurrent abortion
About this study
Official title: Impact of Endometriosis on the Risk of Obstetric Complications in Spontaneous Pregnancy: a Multicentric Italian Study
The aim of this study is to compare the rate of obstetric complications at first spontaneous pregnancy among women with endometriosis, with the rate of obstetric complications at first spontaneous pregnancy among women without endometriosis
Read the detailed description
All women followed up for a surgical or clinical/sonographic diagnosis of endometriosis in 11 italian referral Centres for the treatment of endometriosis, completed a questionnaire regarding their previous pregnancies. The same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or clinical/sonographic evaluation excluded endometriosis.
- Conditions
- Endometriosis, Pregnancy Complications
- Being tested
- Survey on first pregnancy after endometriosis diagnosis, Survey on first pregnancy
- Medical subject headings
- Endometriosis, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey on first pregnancy after endometriosis diagnosisOther
Obstetric complications were noted
Survey on first pregnancyOther
Obstetric complications were noted
| Study group | Role | What they receive |
|---|---|---|
| endometriosis | Survey on first pregnancy after endometriosis diagnosis Receives: Other: Survey on first pregnancy after endometriosis diagnosis | |
| non endometriosis | Survey on first pregnancy Receives: Other: Survey on first pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-term delivery
comparison of rate of preterm delivery in the two groups
Measured: 2 years
Secondary outcomes (1)
Placenta praevia
comparison of rate of placenta praevia in the two groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start15 Jan 2016
- Primary completion4 Oct 2017
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 844 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endometriosis Treatment Italian Club
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Sponsor
- Investigators
- Nicola Berlanda, MD, Principal investigator, Endometriosis Treatment Italian Club
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354793
- Sponsor's protocol ID
- ETIC002
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berlanda N, Alio W, Angioni S, Bergamini V, Bonin C, Boracchi P, Candiani M, Centini G, D'Alterio MN, Del Forno S, Donati A, Dridi D, Incandela D, Lazzeri L, Maiorana A, Mattei A, Ottolina J, Orenti A, Perandini A, Perelli F, Piacenti I, Pino I, Porpora MG, Scaramuzzino S, Seracchioli R, Solima E, Somigliana E, Venturella R, Vercellini P, Vigano P, Vignali M, Zullo F, Zupi E; Endometriosis Treatment Italian Club (ETIC). Impact of endometriosis on obstetric outcome after natural conception: a multicenter Italian study. Arch Gynecol Obstet. 2022 Jan;305(1):149-157. doi: 10.1007/s00404-021-06243-z. Epub 2021 Oct 8.
PubMed 34623489
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endometriosis on the Risk of Obstetric Complications in Spontaneous Pregnancy: a Multicentric Italian Study
- ClinicalTrials.gov ID
- NCT03354793
- Acronym / sponsor ID
- ETIC002
- Conditions
- Endometriosis, Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 844 participants (actual)
- Lead sponsor
- Endometriosis Treatment Italian ClubUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 28 Nov 2017 (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.
The aim of this study is to compare the rate of obstetric complications at first spontaneous pregnancy among women with endometriosis, with the rate of obstetric complications at first spontaneous pregnancy among women without endometriosis
Detailed description
All women followed up for a surgical or clinical/sonographic diagnosis of endometriosis in 11 italian referral Centres for the treatment of endometriosis, completed a questionnaire regarding their previous pregnancies. The same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or clinical/sonographic evaluation excluded endometriosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometriosis | – | Other: Survey on first pregnancy after endometriosis diagnosisSurvey on first pregnancy after endometriosis diagnosis |
| non endometriosis | – | Other: Survey on first pregnancySurvey on first pregnancy |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All continuous women attending endometriosis clinics or undergoing a routine gynecological examination matching the inclusion criteria
Key inclusion criteria (1 listed)
- 30 to 50 years old women with at least one previous spontaneous pregnancy > 12 weeks with surgical or clinical/sonographic diagnosis of endometriosis or in whom surgical or clinical/sonographic evaluation ruled out endometriosis
Key exclusion criteria (7 listed)
- Pregnancy achieved by assisted reproductive techniques
- Pregnancy terminated before 12 gestational weeks
- Twin pregnancy
- Preexisting hypertension
- Lupus like anti-coagulant
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 |
|---|---|---|
| Survey on first pregnancy after endometriosis diagnosisObstetric complications were noted | Other | endometriosis |
| Survey on first pregnancyObstetric complications were noted | Other | non endometriosis |
Primary outcome
Pre-term delivery
Time frame: 2 years
comparison of rate of preterm delivery in the two groups
1 secondary outcome
Placenta praevia
Time frame: 2 years
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 28 Nov 2017.
- Derived from this study: PubMed 34623489Berlanda N, Alio W, Angioni S, Bergamini V, Bonin C, Boracchi P, Candiani M, Centini G, D'Alterio MN, Del Forno S, Donati A, Dridi D, Incandela D, Lazzeri L, Maiorana A, Mattei A, Ottolina J, Orenti A, Perandini A, Perelli F, Piacenti I, Pino I, Porpora MG, Scaramuzzino S, Seracchioli R, Solima E, Somigliana E, Venturella R, Vercellini P, Vigano P, Vignali M, Zullo F, Zupi E; Endometriosis Treatment Italian Club (ETIC). Impact of endometriosis on obstetric outcome after natural conception: a multicenter Italian study. Arch Gynecol Obstet. 2022 Jan;305(1):149-157. doi: 10.1007/s00404-021-06243-z. Epub 2021 Oct 8.
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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.
Nicola Berlanda, MD principal investigator
Endometriosis Treatment Italian Club
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Pregnancy Complications, run by Endometriosis Treatment Italian Club.
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 1 inclusion and 7 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 28 Nov 2017. 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?
Pre-term delivery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354793, which also lists 1 linked publication.
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 28 Nov 2017.