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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.
Over the past 10 years, numerous epidemiological studies have revealed an association between endometriosis and risk of adverse obstetrical events. Among the various mechanisms involved in the occurrence of some obstetrical diseases, alteration of endometrial/myometrial junction (JZ) would lead to abnormal trophoblastic invasion of the myometrial junctional zone due to partial or absent remodeling of uterine spiral arteries.
There are currently few studies in the literature on the topic, and those that do exist report conflicting results on the association between JZ alterations and risk of postpartum hemorrhage. Altered uterine contractile capacity and abnormal trophoblastic invasion of the myometrial endometrial junctional zone are the mechanisms called into question that could explain the increased risk of postpartum hemorrhage in patients. With this background, the purpose of our study is to highlight whether the presence of poor definition of the endometrial/myometrial junction, its thickening, or the presence in its context of irregularities and discontinuities represent a risk factor associated with the development of postpartum hemorrhage or are uterine ecostructural changes that develop consequent to a postpartum hemorrhage event.
All patients will be recruited during the puerperium stay at the Division of Obstetrics and Prenatal Age Medicine at Sant'Orsola Polyclinic. Subsequently, women will undergo gynecological examination and transvaginal ultrasound 6-12 months after delivery at the outpatient clinics of the same division.
In addition to the standard transvaginal gynecologic examination and ultrasonography, a 3D evaluation of the uterus and the endometrium-myometrium junctional zone will be performed using a Voluson E8 ultrasound machine (GE, Milan, Italy). This assessment will be quick and painless for the patient and it will last a maximum of five minutes.
For each patient, information will be collected on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria Group A:
Inclusion Criteria Group B:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gianluigi Pilu, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |