Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst

NCT04526392 | Unknown

• 1 other identifier: RC31/19/0497
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This study is based on pubertal surveillance of fetal ovarian cysts (KOF). Fetal ovarian cysts (KOF) detected during fetal ultrasound examinations occur during the 3rd trimester of pregnancy and are of unknown cause.

Conditions

Fetal Ovarian Cyst

Keywords

child; puberty

Outcome Measures

Primary Outcomes (1)

• Age of onset of first menstruation

  Age of onset of first menstruation defined with one decimal place (year and month).

  Day 1

Secondary Outcomes (14)

• Average age of maternal and sister rules

  Day 1

• Ovarian volumes

  Day 1

• Presence or not of follicles

  Day 1

• first menstruation description - age of breast onset

  Day 1

• first menstruation description - cycle length

  Day 1

Study Arms (1)

Questionnaire

Patients will choose how they wish to complete the Pubertal Course Questionnaire: electronically (web link), on paper, by telephone, or face-to-face at a follow-up consultation.

Other: Questionnaire

Interventions

Questionnaire OTHER

Pubertal course questionnaire

Questionnaire

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Young girls who have to answer a questionnaire on their pubertal development. Estimated duration of data collection by questionnaire for one participant: 30 minutes maximum.

You may qualify if:

• Patients being followed for fetal ovarian cyst.
• Minor patients of whom at least one of the two holders of parental authority has given his or her non-opposition.
• Patients covered by a social security scheme.

You may not qualify if:

• Ovarian cysts outside the neonatal period
• Refusal to participate.
• Opposition to disclosure of neonatal data.
• Pregnant or nursing patient.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Neonatal ovarian cyst

Interventions

Surveys and Questionnaires

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

• Catherine PIENKOWSKI, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine PIENKOWSKI, MD

CONTACT

5 34 55 85 53; pienkowski.c@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 25, 2020
• Study Start: April 6, 2020
• Primary Completion: April 15, 2023
• Study Completion: July 30, 2023
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)