Endometriosis and Obstetric Outcomes

December 11, 2020 updated by: Carlo Alboni, MD, PhD, Azienda Ospedaliero-Universitaria di Modena

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41125
        • Recruiting
        • Carlo Alboni
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm delivery
Time Frame: Time of delivery
Incidence of delivery before 37 weeks of pregnancy
Time of delivery
Gestational diabetes
Time Frame: after 18 weeks' pregnancy
fasting blood glucose >17 mmol/L
after 18 weeks' pregnancy
Gestational hypertension
Time Frame: after 20 weeks' gestation
blood pressure persistently > 140/90 mm Hg
after 20 weeks' gestation
Assisted reproduction technologies
Time Frame: before pregnancy
Patients who referred to assisted reproduction technologies
before pregnancy
Cesarean Section
Time Frame: Time of delivery
Robson Classifications
Time of delivery
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
Time of 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)
Time of delivery
Apgar scores
Time Frame: Time of delivery
Apgar scores
Time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EndoPreg01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I prefer not to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on Retrospective analysis of obstetrics outcomes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe