Endometriosis and Obstetric Outcomes

• Sponsor: Azienda Ospedaliero-Universitaria di Modena (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04664660
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Anticipated Duration (Months): 11.7
• Patients Per Site Per Month: 29.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis; Obstetric Complication	Other: Retrospective analysis of obstetrics 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 Design

• Study Type: Observational
• Anticipated Enrollment: 350 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Endometriosis and Risk Factors in Pregnancy, Labor and Delivery
• Actual Study Start Date: Mar 10, 2020
• Anticipated Primary Completion Date: Feb 1, 2021
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients with previous histologic diagnosis of endometriosis	Other: Retrospective analysis of obstetrics outcomes; Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.
Patient without endometriosis	Other: Retrospective analysis of obstetrics outcomes; Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.

Outcome Measures

Primary Outcome Measures

1. Preterm delivery [Time of delivery]

   Incidence of delivery before 37 weeks of pregnancy

2. Gestational diabetes [after 18 weeks' pregnancy]

   fasting blood glucose >17 mmol/L

3. Gestational hypertension [after 20 weeks' gestation]

   blood pressure persistently > 140/90 mm Hg

4. Assisted reproduction technologies [before pregnancy]

   Patients who referred to assisted reproduction technologies

5. Cesarean Section [Time of delivery]

   Robson Classifications

6. 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

7. 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)

8. Apgar scores [Time of delivery]

   Apgar scores

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carlo Alboni	Modena		Italy	41125

Sponsors and Collaborators

• Azienda Ospedaliero-Universitaria di Modena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 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
• ClinicalTrials.gov Identifier: NCT04664660
• Other Study ID Numbers: EndoPreg01
• First Posted: Dec 11, 2020
• Last Update Posted: Dec 14, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by 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: Endometriosis; Obstetric outcome; Delivery outcome; Neonatal outcome
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Dec 14, 2020