Endometriosis and Obstetric Outcomes

• Conditions: Endometriosis; Obstetric Complication
• Interventions: Other: Retrospective analysis of obstetrics outcomes

• Registration Number: NCT04664660
• Lead Sponsor: 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

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 Timeline

• Study Start: 2020-03-10
• Status Verified: 2020-12
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14
• Primary Completion: 2021-02-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 350

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with previous histologic diagnosis of endometriosis	Retrospective analysis of obstetrics outcomes	-
Patient without endometriosis	Retrospective analysis of obstetrics outcomes	-

Primary Outcome Measures

Name	Time	Method
Gestational hypertension	after 20 weeks' gestation	blood pressure persistently \> 140/90 mm Hg
Cesarean Section	Time of delivery	Robson Classifications
Gestational diabetes	after 18 weeks' pregnancy	fasting blood glucose \>17 mmol/L
Postpartum hemorrhage	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 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 of delivery	Incidence of delivery before 37 weeks of pregnancy
Assisted reproduction technologies	before pregnancy	Patients who referred to assisted reproduction technologies
Apgar scores	Time of delivery	Apgar scores

Trial Locations

Locations (1)

Carlo Alboni; 🇮🇹 Modena, Italy