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

NCT06802874 | Recruiting

• 1 other identifier: PEG18
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss

Keywords

Pregnancy blood loss

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Frequency of finding abnormal ultrasound findings corresponding to the etiology of bleeding

  During the obstetric ultrasound performed at the time of admission

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisa Morganti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Montaguti, MD

CONTACT

0512144369; elisa.montaguti@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 31, 2025
• Study Start: November 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 31, 2025

Record last verified: 2024-10

Locations

IT (1)