Endometriosis and Obstetric Outcomes

NCT04664660 | Unknown

• 1 other identifier: EndoPreg01
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometriosis; Obstetric Complication

Keywords

Endometriosis; Obstetric outcome; Delivery outcome; Neonatal outcome

Outcome Measures

Primary Outcomes (8)

• Preterm delivery

  Incidence of delivery before 37 weeks of pregnancy

  Time of delivery

• Gestational diabetes

  fasting blood glucose \>17 mmol/L

  after 18 weeks' pregnancy

• Gestational hypertension

  blood pressure persistently \> 140/90 mm Hg

  after 20 weeks' gestation

• Assisted reproduction technologies

  Patients who referred to assisted reproduction technologies

  before pregnancy

• Cesarean Section

  Robson Classifications

  Time of delivery

• 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

• 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

• Apgar scores

  Apgar scores

  Time of delivery

Study Arms (2)

Patients with previous histologic diagnosis of endometriosis

Other: Retrospective analysis of obstetrics outcomes

Patient without endometriosis

Other: Retrospective analysis of obstetrics outcomes

Interventions

Retrospective analysis of obstetrics outcomes OTHER

Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.

Patient without endometriosis; Patients with previous histologic diagnosis of endometriosis

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Clinical records not available

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

Carlo Alboni

Modena, 41125, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Carlo Alboni

CONTACT

0594224387; alboni.carlo@aou.mo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Carlo Alboni MD, PhD Head of Minimally Invasive and Robotic Gynecologic Surgery Unit University Hospital of Modena - Italy

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 11, 2020
• Study Start: March 10, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)