Perinatal Consequences of Endometriosis (ENDOBST)

Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study

Endometriosis is a benign gynecological disease, characterized by the presence of endometrium-like tissue outside the uterine cavity that affect up to 10-15% of women in reproductive age worldwide, with an extensive impact on women's wellbeing and their reproductive life. Endometriosis lesions are heterogeneous and three phenotypes of the disease are well recognized and are fundamentally different from each other: superficial peritoneal endometriosis (peritoneal implants), ovarian endometrioma (cyst ovarian endometriosis), and deeply infiltrating endometriosis (invasive nodules greater than 5 mm).

The investigators performed a prospective multicenter comparative study to assess the maternal and fetal risks related to endometriosis during pregnancy, regarding disease phenotype, This study will evaluate with sufficient power the risk of prematurity and obstetrical complications associated with endometriosis according to disease phenotype.

This study aims to provide new informations to pregnant women with endometriosis, guide the monitoring of pregnancy, optimize management strategies based on the nature of complications and ultimately to improve the health of women and their unborn child

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Biological: Biological collection

Detailed Description

Design selected and justification: the study ENDOBST is a

• exposed / unexposed type
• in superiority
• with two comparative groups (endometriosis / without endometriosis)
• Ratio of distribution of subjects in study groups = 1: 2

ENDOBST is a comparative prospective multicenter study presentation exposed - unexposed type. The study aims to compare the outcomes of pregnancy in the whole exposed group to controls and then according to the three disease phenotype (superficial, ovarian, and deep endometriosis).

Endobst aims to test the hypothesis that women with endometriosis have an increased risk of preterm delivery (primary endpoint) and an increased risk of pregnancy complications (secondary endpoints) when compared to diseases-free women. Comparisons will be performed according to disease phenotype.

These analyzes will be conducted after taking into account factors likely to influence the occurrence of preterm birth such as particularly social characteristics (education level, employment status), age and body mass index of women, pathological medical and obstetrical history and behavioral factors (tobacco).

Secondary analyzes will be conducted to investigate the link between endometriosis, and other adverse pregnancy outcomes (premature rupture of membranes, intrauterine growth restriction), complications related to the surgical treatment endometriosis prior to pregnancy.

Regarding the previous surgical treatment, the subgroup of women operated for their endometriosis will be compared to the subgroup of non-operated endometriosis in women and free subset of women. Particular attention will be paid to the phenotype of endometriosis and the nature of previous surgical treatment for pregnancy to control bias indication inherent in observational studies. These associations will be studied from multivariate regression models.

• Study Type: Interventional
• Enrollment (Actual): 1444
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Hopital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patient major
• Single Pregnancy
• Patient followed before 22 SA and giving birth in the maternity ward in the study
• Affiliated to health care

Exclusion Criteria:

• Opposition to the use of personal medical data or medical data of their child for research purposes
• Pregnant women with multiple pregnancies
• HIV positive women
• Patients addressed in the center as part of a transfer in utero.
• Women whose pregnancy is complicated by a spontaneous miscarriage before 15 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type exposed; endometriosis	Biological: Biological collection; Blood and saliva samples, placenta and cord blood collection
Experimental: Type unexposed; Without endometriosis	Biological: Biological collection; Blood and saliva samples, placenta and cord blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of preterm delivery	Each delivery greater than or equal to 22 weeks and less than 37 weeks	at Day 0 until 26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
premature rupture of membranes	at Day 0 until 26 weeks
fetal loss	at Day 0 until 11 weeks
intrauterine growth restriction	at Day 0 until 31 weeks
induced or spontaneous preterm birth	at Day 0 until 26 weeks
preeclampsia	at Day 0 until 31 weeks
placenta previa	at Day 0 until 31 weeks
postpartum hemorrhage	at 11 weeks until 31 weeks
number of caesarean	at 11 weeks until 31 weeks

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Charles Chapron, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Francois Goffinet, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2016
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: preterm delivery; endometriosis; caesarean; Pregnancy outcomes of women with or without endometriosis
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: P140304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No