NCT03354780

Brief Summary

The aim of this study is to compare the rate of miscarriage at first spontaneous pregnancy among women with endometriosis with the rate of miscarriage at first spontaneous pregnancy among women without endometriosis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
844

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

November 21, 2017

Last Update Submit

November 27, 2017

Conditions

EndometriosisMiscarriage

Outcome Measures

Primary Outcomes (1)

  • Rate of miscarriage

    comparison of rate of miscarriage in the two groups

    2 years

Study Arms (2)

endometriosis

Survey on first pregnancy after endometriosis diagnosis

Other: Survey on first pregnancy after endometriosis diagnosis

non endometriosis

Survey on first pregnancy

Other: Survey on first pregnancy

Interventions

Survey on first pregnancy after endometriosis diagnosisOTHER

rate of miscarriage was noted

endometriosis
Survey on first pregnancyOTHER

rate of miscarriage was noted

non endometriosis

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All continous women attending endometriosis clinics or undergoing a routine gynecological examination matching the inclusion criteria

You may qualify if:

  • to 50 years old women
  • with at least one previous spontaneous pregnancy
  • with surgical or clinical/sonographic diagnosis of endometriosis or
  • in whom surgical or clinical/sonographic evaluation ruled out endometriosis

You may not qualify if:

  • Pregnancy achieved by Assisted Reproductive technology
  • Biochemical pregnancy
  • Non corrected uterine malformation, poliabortivity, lupus like anticoagulant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EndometriosisAbortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPregnancy Complications

Study Officials

  • Nicola Berlanda, MD

    Endometriosis Treatment Italian Club

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 28, 2017

Study Start

January 15, 2016

Primary Completion

October 4, 2017

Study Completion

October 4, 2017

Last Updated

November 28, 2017

Record last verified: 2017-11