Perinatal Consequences of Endometriosis (ENDOBST)
Primary Purpose
Endometriosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological collection
Sponsored by
About this trial
This is an interventional other trial for Endometriosis focused on measuring endometriosis, preterm delivery, caesarean, Pregnancy outcomes of women with or without endometriosis
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
Sites / Locations
- Hopital Cochin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Type exposed
Type unexposed
Arm Description
endometriosis
Without endometriosis
Outcomes
Primary Outcome Measures
Number of preterm delivery
Each delivery greater than or equal to 22 weeks and less than 37 weeks
Secondary Outcome Measures
premature rupture of membranes
fetal loss
intrauterine growth restriction
induced or spontaneous preterm birth
preeclampsia
placenta previa
postpartum hemorrhage
number of caesarean
Full Information
NCT ID
NCT02498691
First Posted
July 13, 2015
Last Updated
July 31, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02498691
Brief Title
Perinatal Consequences of Endometriosis
Acronym
ENDOBST
Official Title
Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 4, 2016 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
endometriosis, preterm delivery, caesarean, Pregnancy outcomes of women with or without endometriosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1444 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type exposed
Arm Type
Experimental
Arm Description
endometriosis
Arm Title
Type unexposed
Arm Type
Experimental
Arm Description
Without endometriosis
Intervention Type
Biological
Intervention Name(s)
Biological collection
Intervention Description
Blood and saliva samples, placenta and cord blood collection
Primary Outcome Measure Information:
Title
Number of preterm delivery
Description
Each delivery greater than or equal to 22 weeks and less than 37 weeks
Time Frame
at Day 0 until 26 weeks
Secondary Outcome Measure Information:
Title
premature rupture of membranes
Time Frame
at Day 0 until 26 weeks
Title
fetal loss
Time Frame
at Day 0 until 11 weeks
Title
intrauterine growth restriction
Time Frame
at Day 0 until 31 weeks
Title
induced or spontaneous preterm birth
Time Frame
at Day 0 until 26 weeks
Title
preeclampsia
Time Frame
at Day 0 until 31 weeks
Title
placenta previa
Time Frame
at Day 0 until 31 weeks
Title
postpartum hemorrhage
Time Frame
at 11 weeks until 31 weeks
Title
number of caesarean
Time Frame
at 11 weeks until 31 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Chapron, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francois Goffinet, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Perinatal Consequences of Endometriosis
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