Maternal-fetal Outcomes of Genital Blood Loss Beyond 18 Weeks of Pregnancy (PEG18)

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Loss

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Elisa Montaguti, MD; Phone Number: 0512144369; Email: elisa.montaguti@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Elisa Montaguti, MD; Phone Number: 0512144369; Email: elisa.montaguti@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include pregnant patients over 18 weeks of pregnancy referred to the obstetrical emergency department of the division of Obstetrics and Prenatal Age Medicine of IRCCS Azienda Ospedaliero Universitaria di Bologna for genital blood loss.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Frequency of finding abnormal ultrasound findings corresponding to the etiology of bleeding	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.	During the obstetric ultrasound performed at the time of admission

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Elisa Morganti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 26, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: PEG18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No