Clinical trial NCT06802874: Maternal-fetal Outcomes of Genital Blood Loss Beyond 18 Weeks of Pregnancy
Official title: Maternal-fetal Outcomes of Genital Blood Loss Beyond 18 Weeks of Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Loss
Keywords: Pregnancy blood loss
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of hospitalization for genital blood loss
timeFrame: After the 18th week of pregnancy
measure: Percentage of preterm births
timeFrame: After delivery, up to 24 weeks
measure: Percentage of spontaneous deliveries, operative vaginal, cesarean sections (elective, urgent, emergent)
timeFrame: After delivery, up to 24 weeks
measure: Frequency of antihemorrhagic therapy and maternal transfusions
timeFrame: Intra-partum and post-partum, up to 24 weeks
measure: Frequency of live births, average APGAR, average pH of umbilical artery or vein, average neonatal weight
timeFrame: After delivery, up to 24 weeks
measure: Average length of hospitalization in hours
timeFrame: During Hospitalization, up to 24 weeks
Secondary outcomes:
measure: Frequency of finding abnormal ultrasound findings corresponding to the etiology of bleeding
timeFrame: During the obstetric ultrasound performed at the time of admission
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Elisa Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References: