Maternal-fetal Outcomes of Genital Blood Loss Beyond 18 Weeks of Pregnancy

NCT ID: NCT06802874

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-15

Study Completion Date

2026-12-31

Brief Summary

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The primary objective is to assess in terms of frequency the adverse outcomes (premature birth, maternal-fetal haemorrhage, maternal fetal-neonatal death) of pregnancies of women attending the obstetric-gynaecological emergency department for genital bleeding beyond the 18th week of pregnancy.

Detailed Description

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The investigators decided to conduct this study because it is important on the one hand to carefully evaluate maternal-fetal outcomes in pregnancies characterised by genital bleeding in the second and third trimesters and on the other hand to evaluate the sonographic diagnostic capacity for identifying the aetiology of these genital bleedings, in order to understand whether the possibility of identifying a specific cause of the bleeding has also improved over time as sonographic techniques have improved. This could then allow management and subsequent obstetrical controls to be adapted in a more accurate and indivudualised manner.

For the purpose of this study, no study-specific visits are planned. Data collected during pregnancy and delivery data for patients who gave birth at our centre will be analysed.

Conditions

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Blood Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pregnancy beyond 18 weeks gestational age complicated by genital bleeding;
* Age of the patient ≥18 years;
* Delivery at the O.U. of Obstetrics and Prenatal Age Medicine

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisa Morganti, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elisa Montaguti, MD

Role: CONTACT

0512144369

Facility Contacts

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Elisa Montaguti, MD

Role: primary

0512144369

Other Identifiers

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PEG18

Identifier Type: -

Identifier Source: org_study_id

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