Neonatal uterine bleeding as a precursor to adult life endometriosis

• Register: ISRCTN
• Last refreshed on: 6 February 2017
• Main ID: ISRCTN60023255
• Date of registration: 02/01/2017
• Prospective Registration: No
• Primary sponsor: European Academy of Gynaecological Surgery
• Public title: Neonatal uterine bleeding as a precursor to adult life endometriosis
• Scientific title: Multicenter study on neonatal uterine bleeding (NUB) as a precursor in adult endometriosis
• Date of first enrolment: 01/10/2016
• Target sample size: 500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN60023255
• Study type: Observational
• Study design: Prospective observational cross sectional study (Diagnostic)

Countries of recruitment

Belgium, Bulgaria, Cyprus, France, Greece, Hong Kong, Italy, Portugal, Romania, Slovenia, Spain

Contacts

• Name: Vasilios Tanos

Key inclusion & exclusion criteria

Inclusion criteria: All female patients seeking advice for an infertility problem
Exclusion criteria: No exclusion criteria

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Neonatal uterine bleeding (NUB)
Pregnancy and Childbirth

Intervention(s)

When participants attend their appointments in infertility clinic, as part of their routine care, demographic data, reason for the visit (main complaint), past health and drug history as well as family history (questionnaire 2) are recorded. General, gynaecological and ultrasound scan examinations follow. They are then approached by the study team and / or their gynaecologist asking them to participate in the study, explaining that their routine data collected, blood tests, imaging records and if any interventional procedures results will be used for statistical analysis in the study. Once they consent to take part in the study the research team will collect the data by completing the questionnaire. They will be patients at a different stage of their treatment process and the responsibility of the team and / or gynaecologist is to complete the questionnaire along the way of the treatment. The questionnaires will be reviewed once again upon their completion to reassure the correct and complete medical records. Each participant infertility centre will provide 50 -60 patients for the time period of 2 years. The hard copy recorded data will be then send to the European Academy of Gynaecological Surgery - Nicosia Branch, and will be saved in a medical data base. Statistical analysis will follow.

Primary Outcome(s)

Impact of neonatal uterine bleeding in endometriosis formation in adulthood will be measured through medical record review at endline.

Secondary Outcome(s)

Inheritance of endometriosis will be measured by reviewing results of the second questionnaire which examines the pregnancy and labour conditions of the patient’s mother at endline.

Secondary ID(s)

N/A

Source(s) of Monetary Support

European Academy of Gynaecological Surgery