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

NCT04664335 | Completed

• 1 other identifier: Schäfer_Endo_Preg_Del_Comp
• Study Type: observational
• Target: 1,762
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Pregnancy Complications; Delivery Complication; Complication; Miscarriage

Keywords

endometriosis; pregnancy; delivery; miscarriage; cesarian section

Outcome Measures

Primary Outcomes (2)

• pregnancy rate

  pregnancy rate

  through study completion, an average of 1 year

• complications

  complications during pregnancy, delivery, puerperium

  through study completion, an average of 1 year

Study Arms (2)

endometriosis cases

endometriosis laparoscopically removed / child wish

Other: questionnaire

controls

endometriosis laparoscopically excluded / child wish

Other: questionnaire

Interventions

questionnaire OTHER

if no Reply to questionnaire, telephone interview

Also known as: interview

controls; endometriosis cases

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• cases: Operation because of endometriosis at the endometriosis Center, University Hospital Muenster, child wish, wants to participate, correct age group

You may not qualify if:

• cases / controls: declines participation, incorrect age Group, no child wish

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Münster Germany

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Endometriosis; Pregnancy Complications; Abortion, Spontaneous

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sebastian D Schaefer, MD PhD

  University Hospital Muenster, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gynecology

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

DE (1)