Perinatal Consequences of Endometriosis (ENDOBST)

August 29, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hopital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Unité de Recherche Clinique Necker Cochin, France

Investigators

  • Study Chair: Charles Chapron, MD, PhD, Assistance Publique - Hopitaux de Paris
  • Study Director: Francois Goffinet, MD, PhD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

July 15, 2015

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on Biological collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe