Neonatal uterine bleeding as a precursor to adult life endometriosis
| ISRCTN | ISRCTN60023255 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60023255 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/11/2016
- Registration date
- 02/01/2017
- Last edited
- 29/12/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Public
Aretaeio Hospital
55-57, Andrea Avraamides
Strovolos
Nicosia
2024
Cyprus
 ORCID ID |
0000-0002-4695-4630 |
|---|---|
| Phone | +357 22 200 629 |
| v.tanos@aretaeio.com |
Study information
| Study design | Prospective observational cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Multicenter study on neonatal uterine bleeding (NUB) as a precursor in adult endometriosis |
| Study acronym | NUB |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 10/06/2016 |
| Completion date | 30/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 500 |
| Key inclusion criteria | All female patients seeking advice for an infertility problem |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 01/10/2016 |
| Date of final enrolment | 30/09/2017 |
Locations
Countries of recruitment
- Belgium
- Bulgaria
- China
- Cyprus
- France
- Georgia
- Greece
- Hong Kong
- Italy
- Portugal
- Romania
- Slovenia
- Spain
Study participating centres
Strovolos 2024
Nicosia
-
Cyprus
Leuven
3000
Belgium
Peripheral Road
Thessaloniki
541 24
Greece
Unit of Obstetrics and Gynecology
Via Pansini 5
Naples
80131
Italy
Plaza De La Policia Local 3
Valencia
46015
Spain
Maribor
2000
Slovenia
First Floor of Block E (Special Block)
Prince of wales Hospital
Shatin
-
China
Boulevard du XIIeme de Ligne 1
Liege
4000
Belgium
Lyon
69008
France
Elena Doamna street 49
Iasi
700398
Romania
Schiepse Bos 6
Genk
3600
Belgium
Bologna
40138
Italy
1 place Lucie Aubrac
Clermont-Ferrand
63003
France
1 Chavchavadze Avenue
Tbilisi
0179
Georgia
Sofia
1680
Bulgaria
Sponsor information
Hospital/treatment centre
Nicosia Branch
Aretaeio Hospital
55 Andrea Avraamides str. Strovolos
Nicosia
2024
Cyprus
"ROR" |
https://ror.org/00cfkaw62 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
