Perinatal Consequences of Endometriosis

Endometriosis Clinical Trial

— ENDOBST  

Official title:

Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498691
• Other study ID #: P140304
• Status: Completed
• Phase: N/A
• Start date: February 4, 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: July 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1444
• Est. completion date: February 1, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Biological:
• Biological collection
Blood and saliva samples, placenta and cord blood collection

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	premature rupture of membranes		at Day 0 until 26 weeks
Secondary	fetal loss		at Day 0 until 11 weeks
Secondary	intrauterine growth restriction		at Day 0 until 31 weeks
Secondary	induced or spontaneous preterm birth		at Day 0 until 26 weeks
Secondary	preeclampsia		at Day 0 until 31 weeks
Secondary	placenta previa		at Day 0 until 31 weeks
Secondary	postpartum hemorrhage		at 11 weeks until 31 weeks
Secondary	number of caesarean		at 11 weeks until 31 weeks