EndometriosisENDOBSTNCT02498691
Perinatal Consequences of Endometriosis
A study testing Biological collection in people with Endometriosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Biological collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,444 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2016to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient major
- Single Pregnancy
- Patient followed before 22 SA and giving birth in the maternity ward in the study
- Affiliated to health care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study
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
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Biological collection
- Keywords
- endometriosis, preterm delivery, caesarean, Pregnancy outcomes of women with or without endometriosis
- Medical subject headings
- Endometriosis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological collectionBiological
Blood and saliva samples, placenta and cord blood collection
| Study group | Role | What they receive |
|---|---|---|
| Type exposed | Experimental | endometriosis Receives: Biological: Biological collection |
| Type unexposed | Experimental | Without endometriosis Receives: Biological: Biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of preterm delivery
Each delivery greater than or equal to 22 weeks and less than 37 weeks
Measured: at Day 0 until 26 weeks
Secondary outcomes (8)
premature rupture of membranes
Measured: at Day 0 until 26 weeks
fetal loss
Measured: at Day 0 until 11 weeks
intrauterine growth restriction
Measured: at Day 0 until 31 weeks
induced or spontaneous preterm birth
Measured: at Day 0 until 26 weeks
preeclampsia
Measured: at Day 0 until 31 weeks
placenta previa
Measured: at Day 0 until 31 weeks
postpartum hemorrhage
Measured: at 11 weeks until 31 weeks
number of caesarean
Measured: at 11 weeks until 31 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study start4 Feb 2016
- Primary completion30 Dec 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Charles Chapron, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisFrancois Goffinet, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498691
- Sponsor's protocol ID
- P140304
- Acronym
- ENDOBST
- Status last verified
- Aug 2025
- First submitted
- 13 Jul 2015
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35133433
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT02498691
- Acronym / sponsor ID
- ENDOBST / P140304
- Conditions
- Endometriosis
- Keywords
- endometriosis, preterm delivery, caesarean, Pregnancy outcomes of women with or without endometriosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,444 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type exposed | Experimental | Biological: Biological collectionendometriosis |
| Type unexposed | Experimental | Biological: Biological collectionWithout endometriosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient major
- Single Pregnancy
- Patient followed before 22 SA and giving birth in the maternity ward in the study
- Affiliated to health care
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological collectionBlood and saliva samples, placenta and cord blood collection | Biological | Type exposed, Type unexposed |
Primary outcome
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
8 secondary outcomes
premature rupture of membranes
Time frame: at Day 0 until 26 weeks
fetal loss
Time frame: at Day 0 until 11 weeks
intrauterine growth restriction
Time frame: at Day 0 until 31 weeks
induced or spontaneous preterm birth
Time frame: at Day 0 until 26 weeks
preeclampsia
Time frame: at Day 0 until 31 weeks
placenta previa
Time frame: at Day 0 until 31 weeks
postpartum hemorrhage
Time frame: at 11 weeks until 31 weeks
number of caesarean
Time frame: at 11 weeks until 31 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 35133433Marcellin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Chapron, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Francois Goffinet, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological collection in people with Endometriosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of preterm delivery (time frame: at Day 0 until 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02498691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.