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

Recruiting

• Conditions: Blood Loss

• Registration Number: NCT06802874
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2023-11-15
• Status Verified: 2024-10
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-26
• Last Update Submitted: 2025-01-26
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of hospitalization for genital blood loss	After the 18th week of pregnancy
Percentage of preterm births	After delivery, up to 24 weeks
Percentage of spontaneous deliveries, operative vaginal, cesarean sections (elective, urgent, emergent)	After delivery, up to 24 weeks
Frequency of antihemorrhagic therapy and maternal transfusions	Intra-partum and post-partum, up to 24 weeks
Frequency of live births, average APGAR, average pH of umbilical artery or vein, average neonatal weight	After delivery, up to 24 weeks
Average length of hospitalization in hours	During Hospitalization, up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Frequency of finding abnormal ultrasound findings corresponding to the etiology of bleeding	During the obstetric ultrasound performed at the time of admission	To 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.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy