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NCT04664660 Clinical Trial

Endometriosis and Obstetric Outcomes

Endometriosis Clinical Trial

Official title:
Endometriosis and Risk Factors in Pregnancy, Labor and Delivery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04664660
Other study ID # EndoPreg01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 10, 2020
Est. completion date March 1, 2021

Study information
Verified date December 2020
Source Azienda Ospedaliero-Universitaria di Modena
Contact Carlo Alboni
Phone 0594224387
Email alboni.carlo@aou.mo.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date March 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Retrospective analysis of obstetrics outcomes
Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.

Locations
Country Name City State
Italy Carlo Alboni Modena

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preterm delivery Incidence of delivery before 37 weeks of pregnancy Time of delivery
Primary Gestational diabetes fasting blood glucose >17 mmol/L after 18 weeks' pregnancy
Primary Gestational hypertension blood pressure persistently > 140/90 mm Hg after 20 weeks' gestation
Primary Assisted reproduction technologies Patients who referred to assisted reproduction technologies before pregnancy
Primary Cesarean Section Robson Classifications Time of delivery
Primary 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 Time of delivery
Primary Birth-weight small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight over the 90th percentile) Time of delivery
Primary Apgar scores Apgar scores Time of delivery
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