EndometriosisNCT04664660
Endometriosis and Obstetric Outcomes
An observational study of Endometriosis and Obstetric Complication, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
The purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis, Obstetric Complication
- What is being tested?
- Retrospective analysis of obstetrics outcomes
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2020to 1 Mar 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women who delivered at Azienda Ospedaliero Universitaria Policlinico di Modena from 2000 to 2020. Women with a histological diagnosis of endometriosis before pregnancy matched by age with healthy controls.
Who may be able to join
- Pregnant women who delivered at Azienda Ospedaliero Universitaria Policlinico di Modena from 2000 to 2020
- Histologic diagnosis of endometriosis before pregnancy for case group
- Age matched healthy patients for control group
Who cannot join
- Clinical records not available
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Carlo Alboni
Modena, 41125
Carlo Alboni, MD, PhD, 0594224387, alboni.carlo@aou.mo.it
About this study
Official title: Endometriosis and Risk Factors in Pregnancy, Labor and Delivery
The purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes
Read the detailed description
This is a retrospective, observational, case-control study. Pregnancy, delivery and neonatal outcomes will be analyzed in two groups of patients (case and control group): women with diagnosis of endometriosis histologically confirmed and women without endometriosis. Women with endometriosis will be matched to controls by age. A database with general medical and gynecological history, pregnancy course, delivery mode and newborn conditions will be analyzed.
- Conditions
- Endometriosis, Obstetric Complication
- Being tested
- Retrospective analysis of obstetrics outcomes
- Keywords
- Endometriosis, Obstetric outcome, Delivery outcome, Neonatal outcome
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective analysis of obstetrics outcomesOther
Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.
| Study group | Role | What they receive |
|---|---|---|
| Patients with previous histologic diagnosis of endometriosis | Not described Receives: Other: Retrospective analysis of obstetrics outcomes | |
| Patient without endometriosis | Not described Receives: Other: Retrospective analysis of obstetrics outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm delivery
Incidence of delivery before 37 weeks of pregnancy
Measured: Time of delivery
Gestational diabetes
fasting blood glucose >17 mmol/L
Measured: after 18 weeks' pregnancy
Gestational hypertension
blood pressure persistently > 140/90 mm Hg
Measured: after 20 weeks' gestation
Assisted reproduction technologies
Patients who referred to assisted reproduction technologies
Measured: before pregnancy
Cesarean Section
Robson Classifications
Measured: Time of delivery
Postpartum hemorrhage
Greater than 500 mL estimated blood loss in a vaginal delivery or greater than 1000 mL estimated blood loss at the time of cesarean delivery
Measured: Time of delivery
Birth-weight
small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight over the 90th percentile)
Measured: Time of delivery
Apgar scores
Apgar scores
Measured: Time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start10 Mar 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Alboni, MD, PhD, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664660
- Sponsor's protocol ID
- EndoPreg01
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I prefer not to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometriosis and Risk Factors in Pregnancy, Labor and Delivery
- ClinicalTrials.gov ID
- NCT04664660
- Acronym / sponsor ID
- EndoPreg01
- Conditions
- Endometriosis, Obstetric Complication
- Keywords
- Endometriosis, Obstetric outcome, Delivery outcome, Neonatal outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 11 Dec 2020 (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 purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes
Detailed description
This is a retrospective, observational, case-control study. Pregnancy, delivery and neonatal outcomes will be analyzed in two groups of patients (case and control group): women with diagnosis of endometriosis histologically confirmed and women without endometriosis. Women with endometriosis will be matched to controls by age. A database with general medical and gynecological history, pregnancy course, delivery mode and newborn conditions will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with previous histologic diagnosis of endometriosis | – | Other: Retrospective analysis of obstetrics outcomes |
| Patient without endometriosis | – | Other: Retrospective analysis of obstetrics outcomes |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women who delivered at Azienda Ospedaliero Universitaria Policlinico di Modena from 2000 to 2020. Women with a histological diagnosis of endometriosis before pregnancy matched by age with healthy controls.
Key inclusion criteria (3 listed)
- Pregnant women who delivered at Azienda Ospedaliero Universitaria Policlinico di Modena from 2000 to 2020
- Histologic diagnosis of endometriosis before pregnancy for case group
- Age matched healthy patients for control group
Key exclusion criteria (1 listed)
- Clinical records not available
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 |
|---|---|---|
| Retrospective analysis of obstetrics outcomesRetrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions. | Other | Patient without endometriosis, Patients with previous histologic diagnosis of endometriosis |
Primary outcome
Preterm delivery
Time frame: Time of delivery
Incidence of delivery before 37 weeks of pregnancy
Gestational diabetes
Time frame: after 18 weeks' pregnancy
fasting blood glucose >17 mmol/L
Gestational hypertension
Time frame: after 20 weeks' gestation
blood pressure persistently > 140/90 mm Hg
Assisted reproduction technologies
Time frame: before pregnancy
Patients who referred to assisted reproduction technologies
Cesarean Section
Time frame: Time of delivery
Robson Classifications
Postpartum hemorrhage
Time frame: Time of delivery
Greater than 500 mL estimated blood loss in a vaginal delivery or greater than 1000 mL estimated blood loss at the time of cesarean delivery
Birth-weight
Time frame: Time of delivery
small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight over the 90th percentile)
Apgar scores
Time frame: Time of delivery
Apgar scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: No. I prefer not to share individual participant data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Obstetric Complication, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Alboni (0594224387, alboni.carlo@aou.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm delivery (time frame: Time of delivery). The study lists 8 primary outcomes in all. 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 14 Dec 2020.