Maternal-fetal Outcomes of Genital Blood Loss Beyond 18 Weeks of Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Blood Loss. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Rate of hospitalization for genital blood loss [Time frame: After the 18th week of pregnancy]
- Percentage of preterm births [Time frame: After delivery, up to 24 weeks]
- Percentage of spontaneous deliveries, operative vaginal, cesarean sections (elective, urgent, emergent) [Time frame: After delivery, up to 24 weeks]
- Frequency of antihemorrhagic therapy and maternal transfusions [Time frame: 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 [Time frame: After delivery, up to 24 weeks]
- Average length of hospitalization in hours [Time frame: During Hospitalization, up to 24 weeks]
Secondary outcome measures (1)
- Frequency of finding abnormal ultrasound findings corresponding to the etiology of bleeding [Time frame: During the obstetric ultrasound performed at the time of admission]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06802874 · PEG18