Perinatal Consequences of Endometriosis

NCT ID: NCT02498691

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1444 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-04
• Study Completion Date: 2019-02-01

Brief Summary

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

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.

Conditions

Endometriosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Type exposed

endometriosis

Group Type: EXPERIMENTAL

Biological collection

Intervention Type: BIOLOGICAL

Blood and saliva samples, placenta and cord blood collection

Type unexposed

Without endometriosis

Group Type: EXPERIMENTAL

Biological collection

Intervention Type: BIOLOGICAL

Blood and saliva samples, placenta and cord blood collection

Interventions

Biological collection

Blood and saliva samples, placenta and cord blood collection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Chapron, MD, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Francois Goffinet, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hopital Cochin

Paris, , France

Countries

France

References

Marcellin L, Goffinet F, Azria E, Thomin A, Garabedian C, Sibiude J, Verspyck E, Koskas M, Santulli P, Rousseau J, Ancel PY, Chapron C. Association Between Endometriosis Phenotype and Preterm Birth in France. JAMA Netw Open. 2022 Feb 1;5(2):e2147788. doi: 10.1001/jamanetworkopen.2021.47788.

Reference Type: BACKGROUND

PMID: 35133433 (View on PubMed)

Other Identifiers

P140304

Identifier Type: -

Identifier Source: org_study_id