Condition category
Pregnancy and Childbirth
Date applied
03/11/2016
Date assigned
02/01/2017
Last edited
29/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

European Academy of Gynaecological Surgery

Sponsor details

Nicosia Branch
Aretaeio Hospital
55 Andrea Avraamides str. Strovolos
Nicosia
2024
Cyprus

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes