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Perinatal Consequences of Endometriosis (ENDOBST)

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ClinicalTrials.gov Identifier: NCT02498691
Recruitment Status : Unknown
Verified August 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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


Condition or disease Intervention/treatment Phase
Endometriosis Biological: Biological collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study
Actual Study Start Date : February 4, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. premature rupture of membranes [ Time Frame: at Day 0 until 26 weeks ]
  2. fetal loss [ Time Frame: at Day 0 until 11 weeks ]
  3. intrauterine growth restriction [ Time Frame: at Day 0 until 31 weeks ]
  4. induced or spontaneous preterm birth [ Time Frame: at Day 0 until 26 weeks ]
  5. preeclampsia [ Time Frame: at Day 0 until 31 weeks ]
  6. placenta previa [ Time Frame: at Day 0 until 31 weeks ]
  7. postpartum hemorrhage [ Time Frame: at 11 weeks until 31 weeks ]
  8. number of caesarean [ Time Frame: at 11 weeks until 31 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02498691


Locations
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France
Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Charles Chapron, MD, PhD Assistance Publique - Hôpitaux de Paris
Study Director: Francois Goffinet, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02498691    
Other Study ID Numbers: P140304
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
endometriosis
preterm delivery
caesarean
Pregnancy outcomes of women with or without endometriosis
Additional relevant MeSH terms:
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Endometriosis