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Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04664335
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.


Condition or disease Intervention/treatment
Endometriosis Pregnancy Complications Delivery Complication Complication Miscarriage Other: questionnaire

Study Design
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Study Type : Observational
Actual Enrollment : 1762 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study
Actual Study Start Date : January 2016
Actual Primary Completion Date : October 2019
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
endometriosis cases
endometriosis laparoscopically removed / child wish
 Other: questionnaire
if no Reply to questionnaire, telephone interview
Other Name: interview
controls
endometriosis laparoscopically excluded / child wish
 Other: questionnaire
if no Reply to questionnaire, telephone interview
Other Name: interview


Outcome Measures
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Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: through study completion, an average of 1 year ]
    pregnancy rate

  2. complications [ Time Frame: through study completion, an average of 1 year ]
    complications during pregnancy, delivery, puerperium


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • cases / controls: declines participation, incorrect age Group, no child wish
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664335


Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Sebastian D Schaefer, MD PhD University Hospital Muenster, Germany
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dr. med. Sebastian Daniel Schäfer, Head of Gynecology, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04664335    
Other Study ID Numbers: Schäfer_Endo_Preg_Del_Comp
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: will share upon reasonable request according to regulations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster:
endometriosis
pregnancy
delivery
miscarriage
cesarian section
Additional relevant MeSH terms:
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Endometriosis
Abortion, Spontaneous
Pregnancy Complications