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NCT04664335 Clinical Trial

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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04664335
Other study ID # Schäfer_Endo_Preg_Del_Comp
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2016
Est. completion date December 1, 2020

Study information
Verified date August 2022
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 1762
Est. completion date December 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• questionnaire
if no Reply to questionnaire, telephone interview

Locations
Country Name City State
Germany University Hospital Münster Germany Münster NRW

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary pregnancy rate pregnancy rate through study completion, an average of 1 year
Primary complications complications during pregnancy, delivery, puerperium through study completion, an average of 1 year
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