NCT02498691

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,444

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

February 4, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

July 13, 2015

Last Update Submit

August 29, 2025

Conditions

Endometriosis

Keywords

endometriosispreterm deliverycaesareanPregnancy outcomes of women with or without endometriosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Type exposed

EXPERIMENTAL

endometriosis

Biological: Biological collection

Type unexposed

EXPERIMENTAL

Without endometriosis

Biological: Biological collection

Interventions

Biological collectionBIOLOGICAL

Blood and saliva samples, placenta and cord blood collection

Type exposedType unexposed

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75014, France

Location

Related Publications (1)

  • 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.

    PMID: 35133433BACKGROUND

MeSH Terms

Conditions

EndometriosisPremature Birth

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy Complications

Study Officials

  • Charles Chapron, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

  • Francois Goffinet, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 15, 2015

Study Start

February 4, 2016

Primary Completion

December 30, 2018

Study Completion

February 1, 2019

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)