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Clinical Trials/NCT04664660
NCT04664660
Unknown
Not Applicable

Endometriosis and Risk Factors in Pregnancy, Labor and Delivery

Azienda Ospedaliero-Universitaria di Modena1 site in 1 country350 target enrollmentMarch 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Azienda Ospedaliero-Universitaria di Modena
Enrollment
350
Locations
1
Primary Endpoint
Gestational diabetes
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 10, 2020
End Date
March 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Eligibility 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

Outcomes

Primary Outcomes

Gestational diabetes

Time Frame: after 18 weeks' pregnancy

fasting blood glucose \>17 mmol/L

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)

Preterm delivery

Time Frame: Time of delivery

Incidence of delivery before 37 weeks of pregnancy

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

Apgar scores

Time Frame: Time of delivery

Apgar scores

Study Sites (1)

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