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Completed

NCT Number: NCT02498691

Perinatal Consequences of Endometriosis

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Cochin

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological collection

Biological

Blood and saliva samples, placenta and cord blood collection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study

Acronym: ENDOBST

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 15, 2015
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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