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NCT Number: NCT06802874

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Elisa Montaguti, MD

CONTACT

[email protected]

0512144369

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of hospitalization for genital blood loss

    Time frame: After the 18th week of pregnancy

  2. Percentage of preterm births

    Time frame: After delivery, up to 24 weeks

  3. Percentage of spontaneous deliveries, operative vaginal, cesarean sections (elective, urgent, emergent)

    Time frame: After delivery, up to 24 weeks

  4. Frequency of antihemorrhagic therapy and maternal transfusions

    Time frame: Intra-partum and post-partum, up to 24 weeks

  5. Frequency of live births, average APGAR, average pH of umbilical artery or vein, average neonatal weight

    Time frame: After delivery, up to 24 weeks

  6. Average length of hospitalization in hours

    Time frame: During Hospitalization, up to 24 weeks

Secondary outcomes

  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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Montaguti, MD

CONTACT

[email protected]

0512144369

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: PEG18

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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