EndometriosisNCT04664335
Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study
An observational study of Endometriosis and Pregnancy Complications, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Purpose: To study the impact of endometriosis on subsequent pregnancy and delivery. Methods: retrospective analysis by questionnaire / interview of cases (endometriosis laparoscopically removed / child wish) vs. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Pregnancy Complications, Delivery Complication
- What is being tested?
- questionnaire
- How many people
- 1,762 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2016to 1 Dec 2020
- Phase
- Observational
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016
Who may be able to join
- cases: Operation because of endometriosis at the endometriosis Center, University Hospital Muenster, child wish, wants to participate, correct age group
- controls: Operation because of sterility, exclusion of endometriosis during this Operation, child wish, wants to participate, correct age group
Who cannot join
- cases / controls: declines participation, incorrect age Group, no child wish
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Münster Germany
Münster, North Rhine-Westphalia, 48149
About this study
Purpose:
To study the impact of endometriosis on subsequent pregnancy and delivery.
Methods:
retrospective analysis by questionnaire / interview of cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016; analysis of pregnancy rate, mode of delivery and complications using Clavien-Dindo-classification, role of deep infiltrating endometriosis using ENZIAN classification; data analysis using t-test with p < 0.050% being considered significant.
- Being tested
- questionnaire
- Keywords
- endometriosis, pregnancy, delivery, miscarriage, cesarian section
- Medical subject headings
- Endometriosis, Pregnancy Complications, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Also called interview
if no Reply to questionnaire, telephone interview
| Study group | Role | What they receive |
|---|---|---|
| endometriosis cases | endometriosis laparoscopically removed / child wish Receives: Other: questionnaire | |
| controls | endometriosis laparoscopically excluded / child wish Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
pregnancy rate
Measured: through study completion, an average of 1 year
complications
complications during pregnancy, delivery, puerperium
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Dec 2016
- Primary completion1 Dec 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,762 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster
- Investigators
- Sebastian D Schaefer, MD PhD, Principal investigator, University Hospital Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664335
- Sponsor's protocol ID
- Schäfer_Endo_Preg_Del_Comp
- Status last verified
- Aug 2022
- First submitted
- 4 Dec 2020
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will share upon reasonable request according to regulations
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04664335
- Acronym / sponsor ID
- Schäfer_Endo_Preg_Del_Comp
- Keywords
- endometriosis, pregnancy, delivery, miscarriage, cesarian section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,762 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- 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.
Purpose:
To study the impact of endometriosis on subsequent pregnancy and delivery.
Methods:
retrospective analysis by questionnaire / interview of cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016; analysis of pregnancy rate, mode of delivery and complications using Clavien-Dindo-classification, role of deep infiltrating endometriosis using ENZIAN classification; data analysis using t-test with p < 0.050% being considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometriosis cases | – | Other: questionnaireendometriosis laparoscopically removed / child wish |
| controls | – | Other: questionnaireendometriosis laparoscopically excluded / child wish |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016
Key inclusion criteria (2 listed)
- cases: Operation because of endometriosis at the endometriosis Center, University Hospital Muenster, child wish, wants to participate, correct age group
- controls: Operation because of sterility, exclusion of endometriosis during this Operation, child wish, wants to participate, correct age group
Key exclusion criteria (1 listed)
- cases / controls: declines participation, incorrect age Group, no child wish
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 |
|---|---|---|
| questionnaireAlso: interviewif no Reply to questionnaire, telephone interview | Other | controls, endometriosis cases |
Primary outcome
pregnancy rate
Time frame: through study completion, an average of 1 year
pregnancy rate
complications
Time frame: through study completion, an average of 1 year
complications during pregnancy, delivery, puerperium
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 22 Aug 2022.
- Individual participant dataSharing planned: Undecided. will share upon reasonable request according to regulations
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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.
Sebastian D Schaefer, MD PhD principal investigator
University Hospital Muenster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Pregnancy Complications, run by University Hospital Muenster at 1 site in Germany.
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 2 inclusion and 1 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 22 Aug 2022. 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 Germany. 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?
pregnancy rate (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2022.