Placenta DiseasesPLACENTANCT05172674
Ultrasound Diagnosis of Placental and Umbilical Cord Anomalies in Singleton Pregnancies Resulting From In-vitro Fertilization
An observational study of Placenta Diseases and IVF, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Objectives: to identify which type of placental and umbilical cord abnormalities are more common in IVF singleton pregnancies; to investigate if heterologous fertilization is an additional risk factor for the development of these abnormalities. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Diseases, IVF
- What is being tested?
- ultrasound according routine antenatal care
- How many people
- 587 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2019to 31 Mar 2021
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All patients with a singleton pregnancy conceived with IVF were consecutively recruited between 1st of May 2019 to 31st March 2021. Each case was matched with a control presenting with a SC during the same period of time. All patients had antenatal care using a similar clinical protocol, which included at 11-14 weeks (nuchal thickness screening scan), 19-22 weeks (detailed fetal anatomy scan) and 33-35 weeks (growth scan).
Who may be able to join
- singleton pregnancies
- spontaneous pregnancies or pregnancies conceived with IVF
Who cannot join
- multiple pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Diagnosis of Placental and Umbilical Cord Anomalies in Singleton Pregnancies Resulting From In-vitro Fertilization: a Prospective Cohort Study
Objectives: to identify which type of placental and umbilical cord abnormalities are more common in IVF singleton pregnancies; to investigate if heterologous fertilization is an additional risk factor for the development of these abnormalities.
Methods: this was a multicenter prospective cohort study study involving two tertiary centres (S. Orsola Hospital, University of Bologna and Institute for Women's Health, University College of London). Patients with a singleton pregnancy conceived with IVF were consecutively recruited between May 2019 to January 2021. Each case was matched with a control presenting with a spontaneous pregnancy during the same period of time. All patients underwent similar antenatal care, which included ultrasound examinations at 11-14, 19-22 and 33-35 weeks. Ultrasound findings of placental and/or umbilical cord abnormalities were recorded in the two groups and confirmed after birth. The incidence of placental/cord findings in the study group was assessed using the chi-squared test or Fisher's exact test, where appropriate. Post-hoc pairwise comparisons were performed with the Fisher's exact test, using the Simes' method for false discovery rate control.
Read the detailed description
This was a multicenter prospective cohort study study involving two tertiary centres (S. Orsola Hospital, University of Bologna and Institute for Women's Health and University College of London). All patients with a singleton pregnancy conceived with IVF were consecutively recruited between 1st of May 2019 to 31st March 2021. Each case was matched with a control presenting with a SC during the same period of time.
All patients had antenatal care using a similar clinical protocol, which included at 11-14 weeks (nuchal thickness screening scan), 19-22 weeks (detailed fetal anatomy scan) and 33-35 weeks (growth scan). All ultrasound examinations are carried out transvaginally and/or transabdominally by experienced operators using a high-resolution ultrasound equipment. Ultrasound findings of placental and/or umbilical cord abnormalities were recorded in each case using a standardized reporting protocol including placental location, cord insertion. The placenta was recorded as "low lying" when the edge was 0.5-2 cm from the internal os of the uterine cervix. When the placenta was <0.5cm from the internal os or completely covering it, it was defined as placenta previa (marginal or complete). Ultrasound signs of PAS were recorded using the standardized description proposed by the EW-AIP including for grey scale imaging: loss of clear zone, myometrial thinning, the presence of placental lacunae; bladder wall interruption; placental bulge and focal exophytic mass and for CDI: utero-vesical hypervascularity; subplacental hypervascularity; bridging vessels and lacunae feeder vessels. Additional transabdominal and transvaginal sonographic (TVS) examinations of the placenta and cord insertion were performed at 28-30 weeks and 35-36 weeks when anomalies were identified at the 19-22 weeks scan.
Women with multiple pregnancies or requiring emergency delivery before 32 weeks were excluded from the study group. All patients were managed according to local protocols.
Patient's demographic data, previous obstetric and gynecological history, clinical findings, ultrasound data and images and symptoms at the time of the first examination were recorded and stored in a specialized database (Viewpoint Version 5, Bildverargeritung GmbH, Munich, Germany). All placentas were examined at delivery by the obstetric team and histopathological evaluation has been carried out when clinically indicated.
- Conditions
- Placenta Diseases, IVF
- Being tested
- ultrasound according routine antenatal care
- Medical subject headings
- Placenta Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound according routine antenatal careDiagnostic test
ultrasound examinations at 11-14, 19-22 and 33-35 weeks
| Study group | Role | What they receive |
|---|---|---|
| spontaneous pregnancies | Not described Receives: Diagnostic Test: ultrasound according routine antenatal care | |
| pregnancies arising through IVF (homologus + hetereologus) | Not described Receives: Diagnostic Test: ultrasound according routine antenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
type of placental and umbilical cord abnormalities
to identify which type of placental and umbilical cord abnormalities are more common in IVF singleton pregnancies
Measured: 8 months
heterologous fertilization
to investigate if heterologous fertilization is an additional risk factor for the development of these abnormalities
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 May 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172674
- Sponsor's protocol ID
- 20/2019/Oss/AOUBo
- Acronym
- PLACENTA
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we could share all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Diagnosis of Placental and Umbilical Cord Anomalies in Singleton Pregnancies Resulting From In-vitro Fertilization: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05172674
- Acronym / sponsor ID
- PLACENTA / 20/2019/Oss/AOUBo
- Conditions
- Placenta Diseases, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 29 Dec 2021 (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.
Objectives: to identify which type of placental and umbilical cord abnormalities are more common in IVF singleton pregnancies; to investigate if heterologous fertilization is an additional risk factor for the development of these abnormalities.
Methods: this was a multicenter prospective cohort study study involving two tertiary centres (S. Orsola Hospital, University of Bologna and Institute for Women's Health, University College of London). Patients with a singleton pregnancy conceived with IVF were consecutively recruited between May 2019 to January 2021. Each case was matched with a control presenting with a spontaneous pregnancy during the same period of time. All patients underwent similar antenatal care, which included ultrasound examinations at 11-14, 19-22 and 33-35 weeks. Ultrasound findings of placental and/or umbilical cord abnormalities were recorded in the two groups and confirmed after birth. The incidence of placental/cord findings in the study group was assessed using the chi-squared test or Fisher's exact test, where appropriate. Post-hoc pairwise comparisons were performed with the Fisher's exact test, using the Simes' method for false discovery rate control.
Detailed description
This was a multicenter prospective cohort study study involving two tertiary centres (S. Orsola Hospital, University of Bologna and Institute for Women's Health and University College of London). All patients with a singleton pregnancy conceived with IVF were consecutively recruited between 1st of May 2019 to 31st March 2021. Each case was matched with a control presenting with a SC during the same period of time.
All patients had antenatal care using a similar clinical protocol, which included at 11-14 weeks (nuchal thickness screening scan), 19-22 weeks (detailed fetal anatomy scan) and 33-35 weeks (growth scan). All ultrasound examinations are carried out transvaginally and/or transabdominally by experienced operators using a high-resolution ultrasound equipment. Ultrasound findings of placental and/or umbilical cord abnormalities were recorded in each case using a standardized reporting protocol including placental location, cord insertion. The placenta was recorded as "low lying" when the edge was 0.5-2 cm from the internal os of the uterine cervix. When the placenta was <0.5cm from the internal os or completely covering it, it was defined as placenta previa (marginal or complete). Ultrasound signs of PAS were recorded using the standardized description proposed by the EW-AIP including for grey scale imaging: loss of clear zone, myometrial thinning, the presence of placental lacunae; bladder wall interruption; placental bulge and focal exophytic mass and for CDI: utero-vesical hypervascularity; subplacental hypervascularity; bridging vessels and lacunae feeder vessels. Additional transabdominal and transvaginal sonographic (TVS) examinations of the placenta and cord insertion were performed at 28-30 weeks and 35-36 weeks when anomalies were identified at the 19-22 weeks scan.
Women with multiple pregnancies or requiring emergency delivery before 32 weeks were excluded from the study group. All patients were managed according to local protocols.
Patient's demographic data, previous obstetric and gynecological history, clinical findings, ultrasound data and images and symptoms at the time of the first examination were recorded and stored in a specialized database (Viewpoint Version 5, Bildverargeritung GmbH, Munich, Germany). All placentas were examined at delivery by the obstetric team and histopathological evaluation has been carried out when clinically indicated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spontaneous pregnancies | – | Diagnostic Test: ultrasound according routine antenatal care |
| pregnancies arising through IVF (homologus + hetereologus) | – | Diagnostic Test: ultrasound according routine antenatal care |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients with a singleton pregnancy conceived with IVF were consecutively recruited between 1st of May 2019 to 31st March 2021. Each case was matched with a control presenting with a SC during the same period of time. All patients had antenatal care using a similar clinical protocol, which included at 11-14 weeks (nuchal thickness screening scan), 19-22 weeks (detailed fetal anatomy scan) and 33-35 weeks (growth scan).
Key inclusion criteria (2 listed)
- singleton pregnancies
- spontaneous pregnancies or pregnancies conceived with IVF
Key exclusion criteria (1 listed)
- multiple pregnancies
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 according routine antenatal careultrasound examinations at 11-14, 19-22 and 33-35 weeks | Diagnostic test | pregnancies arising through IVF (homologus + hetereologus), spontaneous pregnancies |
Primary outcome
type of placental and umbilical cord abnormalities
Time frame: 8 months
to identify which type of placental and umbilical cord abnormalities are more common in IVF singleton pregnancies
heterologous fertilization
Time frame: 8 months
to investigate if heterologous fertilization is an additional risk factor for the development of these abnormalities
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 14 Feb 2022.
- Individual participant dataSharing planned: Undecided. we could share all IPD that underlie results in a publication
Related trials for Placenta Diseases
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
RecruitingObservational study
Oxford Luteal Dysfunction and Placental Insufficiency Study
Pre-eclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Placenta Diseases and IVF, 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 2 inclusion and 1 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 14 Feb 2022. 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?
type of placental and umbilical cord abnormalities (time frame: 8 months). The study lists 2 primary outcomes in all. 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 14 Feb 2022.