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Completed

NCT Number: NCT06781528

Postpartum Hemorrhage and Alterations in Uterine Ecostructure

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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:

  • Age
  • Ethnicity
  • Body mass index (BMI)
  • Relevant pathologies
  • Previous uterine surgery (myomectomy, CT scan, OCR)
  • Associated symptoms: Dysmenorrhea, Chronic pelvic pain, Pain on ovulation, Dyspareunia, Dysuria, Dyschezia, Alterations in alvus, Abdominal bloating, Abnormal uterine bleeding (menometrorrhagia or spotting)
  • Presence of uterine fibroids
  • Presence of pelvic endometriosis
  • Parity
  • Mode of pregnancy onset (spontaneous vs. medically assisted procreation)
  • Multiple pregnancy
  • Any placental pathologies: placenta previa, accretism, suspected or established detachment.
  • Any pathologies arising in pregnancy: gestational hypertension, preclampsia, diabetes
  • Gestational age at the time of delivery
  • Mode of delivery (vaginal/caesarean section)
  • Neonatal weight
  • Possible cervical, vulvo-vaginal tears.
  • Abnormalities of secondment
  • Uterine ultrasound features (classification according to MUSA study)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Group A:

  • 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)

Inclusion criteria

Group B:

  • Age > 18 years
  • Acquisition of Informed Consent Form
  • Delivery not complicated by postpartum hemorrhage or other adverse obstetric events

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of the presence of changes in uterine ecostructure

    Time frame: 6-12 months after delivery

    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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2025
Registry last updated
Jan 17, 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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