Plain English Summary
Background and study aims
Neonatal uterine bleeding (NUB) is a condition in which there is a small amount of bleeding or spotting from the vagina of newborn baby girls. It occurs in around 5% of all baby girls and usually happens during the first 2-3 days of life. Endometriosis is a common condition where small pieces of the womb lining (the endometrium) are found in different areas of the body, such as in the ovaries or in the bladder. The cause of endometriosis is still unknown and even after a century of intensive research it is still difficult to diagnose. The aim of this study is to collected routine medical data in order to find out if there is a link between NUB and the development of endometriosis in adulthood and if endometriosis is inherited.
Who can participate?
All female patients seeking advice for an infertility problem at a participating centre.
What does the study involve?
After agreeing to take part, participants complete a number of questionnaires in order to collect information about their health and personal information. The results of these questionnaires are then cross-checked with medical records which are reviewed to find out if there is a link between NUB and endometriosis formation in adulthood, as well as to see if endometriosis is inherited.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
1. St. George’s Med School, Nicosia University and Aretaeio Hospital (Cyprus)
2. LIFE Expert Centre, Service de Gynécologie-Obstétrique CHR de la Citadelle and Ziekenhuis Oost-Limburg a.v. (Belgium)
3. 1st Dept Obstetrics and Gynecology Aristotle University of Thessaloniki (Greece)
4. University of Federico II, S.I.S.Me.R. srl (Italy)
5. IVI Valencia (Spain)
6. Maribor University Hospital (Slovenia)
7. Chinese University of Hong Kong (China)
8. Hôpital NATECIA and Chirurgie Gynécologique (France)
9. University Hospital of Obstetrics and Gynecology Elena Doamna (Romania)
10. Reproductive Clinic of Zurab Sabakhtarashvili (Georgia)
11. Malinov Clinic (Bulgaria)
When is the study starting and how long is it expected to run for?
June 2016 to September 2018
Who is funding the study?
European Academy of Gynaecological Surgery (Cyprus)
Who is the main contact?
Professor Vasilios Tanos
v.tanos@aretaeio.com
Trial website
Contact information
Type
Public
Primary contact
Prof Vasilios Tanos
ORCID ID
http://orcid.org/0000-0002-4695-4630
Contact details
Aretaeio Hospital
55-57
Andrea Avraamides
Strovolos
Nicosia
2024
Cyprus
+357 22 200 629
v.tanos@aretaeio.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Multicenter study on neonatal uterine bleeding (NUB) as a precursor in adult endometriosis
Acronym
NUB
Study hypothesis
The aim of this study is to determine whether there is a relationship between neonatal uterine bleeding during the first days of life and endometriosis/adenomyosis development later in adolescence or adult life.
Ethics approval
Not provided at time of registration
Study design
Prospective observational cross sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
No participant information sheet available
Condition
Neonatal uterine bleeding (NUB)
Intervention
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.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Impact of neonatal uterine bleeding in endometriosis formation in adulthood will be measured through medical record review at endline.
Secondary outcome measures
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.
Overall trial start date
10/06/2016
Overall trial end date
30/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All female patients seeking advice for an infertility problem
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
500
Participant exclusion criteria
No exclusion criteria
Recruitment start date
01/10/2016
Recruitment end date
30/09/2017
Locations
Countries of recruitment
Belgium, Bulgaria, Cyprus, France, Greece, Hong Kong, Italy, Portugal, Romania, Slovenia, Spain
Trial participating centre
St. George’s Med School, Nicosia University and Aretaeio Hospital
55-57 Andrea Avraamides
Strovolos 2024
Nicosia
-
Cyprus
Trial participating centre
LIFE Expert Centre
Schipvaartstraat 4
Leuven
3000
Belgium
Trial participating centre
1st Dept Obstetrics and Gynecology Aristotle University of Thessaloniki
Papageorgiou Hospital
Peripheral Road
Thessaloniki
541 24
Greece
Trial participating centre
University of Federico II
Department of Public Health
Unit of Obstetrics and Gynecology
Via Pansini 5
Naples
80131
Italy
Trial participating centre
IVI Valencia
Director Department of Surgery
Plaza De La Policia Local 3
Valencia
46015
Spain
Trial participating centre
Maribor University Hospital
Ljubljanska Ulica 5
Maribor
2000
Slovenia
Trial participating centre
Chinese University of Hong Kong
Department of Obstetrics and gynecology
First Floor of Block E (Special Block)
Prince of wales Hospital
Shatin
-
China
Trial participating centre
Service de Gynécologie-Obstétrique CHR de la Citadelle
Présidente du Département de Gynécologie-Obstétrique Université de Liège Belgique
Boulevard du XIIeme de Ligne 1
Liege
4000
Belgium
Trial participating centre
Hôpital NATECIA
22 Avenue Rockefeller
Lyon
69008
France
Trial participating centre
University Hospital of Obstetrics and Gynecology Elena Doamna
Department of Obstetrics and Gynecology Iasi- Romania
Elena Doamna street 49
Iasi
700398
Romania
Trial participating centre
Ziekenhuis Oost-Limburg a.v.
Head Dpt ObGyn
Schiepse Bos 6
Genk
3600
Belgium
Trial participating centre
S.I.S.Me.R. srl
Via Mazzini, 12
Bologna
40138
Italy
Trial participating centre
Chirurgie Gynécologique
Pôle FEE CHU Estaing
1 place Lucie Aubrac
Clermont-Ferrand
63003
France
Trial participating centre
Reproductive Clinic of Zurab Sabakhtarashvili
Tbilisi State University
1 Chavchavadze Avenue
Tbilisi
0179
Georgia
Trial participating centre
Malinov Clinic
Goce Delchev Blvd 46
Sofia
1680
Bulgaria
Funders
Funder type
Hospital/treatment centre
Funder name
European Academy of Gynaecological Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Vasilios Tanos (v.tanos@aretaeio.com) and Prof Stephan Gordts (stephan.gordts@lifeleuven.be or stephan.gordts@lifeexpertcentre.be)
Intention to publish date
31/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list