Postpartum HemorrhageNCT06781528
Postpartum Hemorrhage and Alterations in Uterine Ecostructure
An observational study of Postpartum Hemorrhage, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Ultrasound evaluation
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Known uterine myomas or previous myomectomy surgery
- Presence of pelvic endometriosis
- Maternal hypertensive conditions
- Pluriparity (> 3)
- Multiple pregnancy
- Polydramnios
Show all 10Show fewer
- Obesity (BMI> 35)
- Neonatal macrosomia
- Known coaugulopathies/thrombocytopenias
- Refusal to undergo subsequent follow-up at our center
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
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.
Read the detailed description
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)
- Conditions
- Postpartum Hemorrhage
- Being tested
- Ultrasound evaluation
- Keywords
- endometrium-myometrium junctional zone
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound evaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Ultrasound evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start10 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluigi Pilu, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781528
- Sponsor's protocol ID
- EPP1.0
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Hemorrhage and Alterations in Uterine Ecostructure
- ClinicalTrials.gov ID
- NCT06781528
- Acronym / sponsor ID
- EPP1.0
- Conditions
- Postpartum Hemorrhage
- Keywords
- endometrium-myometrium junctional zone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemorrhagic participants | – | Other: Ultrasound evaluationParticipants 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 | – | Other: Ultrasound evaluationParticipants 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Known uterine myomas or previous myomectomy surgery
- Presence of pelvic endometriosis
- Maternal hypertensive conditions
- Pluriparity (> 3)
- Multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound evaluationAll 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. | Other | Hemorrhagic participants, No hemorrhagic participants |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluigi Pilu, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the presence of changes in uterine ecostructure (time frame: 6-12 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.