Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06802874
Acronym
PEG18
Enrollment
300
Registered
2025-01-31
Start date
2023-11-15
Completion date
2026-12-31
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss

Keywords

Pregnancy blood loss

Brief summary

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

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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of preterm birthsAfter delivery, up to 24 weeks
Frequency of antihemorrhagic therapy and maternal transfusionsIntra-partum and post-partum, up to 24 weeks
Rate of hospitalization for genital blood lossAfter the 18th week of pregnancy
Average length of hospitalization in hoursDuring Hospitalization, up to 24 weeks
Percentage of spontaneous deliveries, operative vaginal, cesarean sections (elective, urgent, emergent)After delivery, up to 24 weeks
Frequency of live births, average APGAR, average pH of umbilical artery or vein, average neonatal weightAfter delivery, up to 24 weeks

Secondary

MeasureTime frameDescription
Frequency of finding abnormal ultrasound findings corresponding to the etiology of bleedingDuring the obstetric ultrasound performed at the time of admissionTo assess whether the ultrasound capability in detecting a specific etiology of bleeding has improved over time in conjunction with the evolution of technology and resolution of ultrasound equipment.

Countries

Italy

Contacts

Primary ContactElisa Montaguti, MD
elisa.montaguti@aosp.bo.it0512144369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026