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Endometriosis and Obstetric Outcomes

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ClinicalTrials.gov Identifier: NCT04664660
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Carlo Alboni, MD, PhD, Azienda Ospedaliero-Universitaria di Modena

Brief Summary:
The purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes

Condition or disease Intervention/treatment
Endometriosis Obstetric Complication Other: Retrospective analysis of obstetrics 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.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Endometriosis and Risk Factors in Pregnancy, Labor and Delivery
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
Patients with previous histologic diagnosis of endometriosis Other: Retrospective analysis of obstetrics outcomes
Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.

Patient without endometriosis Other: Retrospective analysis of obstetrics outcomes
Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.




Primary Outcome Measures :
  1. Preterm delivery [ Time Frame: Time of delivery ]
    Incidence of delivery before 37 weeks of pregnancy

  2. Gestational diabetes [ Time Frame: after 18 weeks' pregnancy ]
    fasting blood glucose >17 mmol/L

  3. Gestational hypertension [ Time Frame: after 20 weeks' gestation ]
    blood pressure persistently > 140/90 mm Hg

  4. Assisted reproduction technologies [ Time Frame: before pregnancy ]
    Patients who referred to assisted reproduction technologies

  5. Cesarean Section [ Time Frame: Time of delivery ]
    Robson Classifications

  6. 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

  7. 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)

  8. Apgar scores [ Time Frame: Time of delivery ]
    Apgar scores



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Clinical records not available

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664660


Contacts
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Contact: Carlo Alboni 0594224387 alboni.carlo@aou.mo.it

Locations
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Italy
Carlo Alboni Recruiting
Modena, Italy, 41125
Contact: Carlo Alboni, MD, PhD    0594224387    alboni.carlo@aou.mo.it   
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena
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Responsible Party: Carlo Alboni, MD, PhD, Dr. Carlo Alboni MD, PhD Head of Minimally Invasive and Robotic Gynecologic Surgery Unit University Hospital of Modena - Italy, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier: NCT04664660    
Other Study ID Numbers: EndoPreg01
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: I prefer not to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlo Alboni, MD, PhD, Azienda Ospedaliero-Universitaria di Modena:
Endometriosis
Obstetric outcome
Delivery outcome
Neonatal outcome
Additional relevant MeSH terms:
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Endometriosis