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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Endometriosis
• Obstetric Complication

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