Postpartum Hemorrhage and Alterations in Uterine Ecostructure

NCT06781528 | Completed

• 1 other identifier: EPP1.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the presence of alterations in the ecostructure of the uterus in patients with a positive history of primary postpartum hemorrhage, in order to demonstrate a statistically significant correlation between these ecostructural alterations and adverse obstetric event.

Conditions

Postpartum Hemorrhage

Keywords

endometrium-myometrium junctional zone

Outcome Measures

Primary Outcomes (1)

• Evaluation of the presence of changes in uterine ecostructure

  Evaluation of the presence of alterations in the ecostructure of the uterus and in particular the endometrium-myometrium junctional zone (JZ) in patients with a positive history of primary postpartum hemorrhage, in order to demonstrate a statistically significant correlation between these ecostructural alterations and adverse obstetric event.

  6-12 months after delivery

Study Arms (2)

Hemorrhagic participants

Participants who deliver at the Division of Obstetrics and Prenatal Age Medicine at Sant'Orsola Polyclinic by vaginal delivery or cesarean section complicated by primary postpartum hemorrhage.

Other: Ultrasound evaluation

No hemorrhagic participants

Participants who deliver at the Division of Obstetrics and Prenatal Age Medicine of Sant'Orsola Polyclinic by vaginal delivery or cesarean section not complicated by postpartum hemorrhage or other adverse obstetrical events matched for gestational age and parity at delivery.

Other: Ultrasound evaluation

Interventions

Ultrasound evaluation OTHER

All patients will undergo 2D and 3D transvaginal ultrasonography 6-12 months after delivery at the outpatient clinics of our center, as per normal care procedure. Ultrasonographic evaluation aims to detect alterations of the uterine ecostructure, particularly of the endometrial-myometrial junctional zone. The presence of typical signs of uterine adenomyosis, in its various forms (diffuse, focal or localized-adenomyoma) will be investigated.

Hemorrhagic participants; No hemorrhagic participants

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Group A will consist of patients who gave birth at the Division of Obstetrics and Prenatal Age Medicine at Sant'Orsola Polyclinic by vaginal delivery or cesarean section complicated by primary postpartum hemorrhage. Group B will consist of women who delivered at the same facility by vaginal delivery or cesarean section not complicated by postpartum hemorrhage or other adverse obstetric events matched for gestational age and parity at delivery.

You may qualify if:

• Age \> 18 years
• Acquisition of Informed Consent Form
• Primary postpartum hemorrhage (defined as blood loss greater than or equal to 1 liter or blood loss that is accompanied by signs and symptoms of hypovolemia occurring within 24 hours of delivery)
• Age \> 18 years
• Acquisition of Informed Consent Form
• Delivery not complicated by postpartum hemorrhage or other adverse obstetric events

You may not qualify if:

• Known uterine myomas or previous myomectomy surgery
• Presence of pelvic endometriosis
• Maternal hypertensive conditions
• Pluriparity (\> 3)
• Multiple pregnancy
• Polydramnios
• Obesity (BMI\> 35)
• Neonatal macrosomia
• Known coaugulopathies/thrombocytopenias
• Refusal to undergo subsequent follow-up at our center

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluigi Pilu, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 17, 2025
• Study Start: June 10, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 17, 2025

Record last verified: 2024-10

Locations

IT (1)