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CompletedNCT05172674PLACENTAUpdated Feb 14, 2022

Ultrasound Diagnosis of Placental and Umbilical Cord Anomalies in Singleton Pregnancies Resulting From In-vitro Fertilization

An observational study in Placenta Diseases and IVF, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed at 1 site in Italy. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-14.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
587
Ages
18 Years to 55 Years
Sex
Female
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Study 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.

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.

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Conditions studied

  • Placenta Diseases
  • IVF

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03

In context

Placenta Diseases

24 studies on the registry are indexed under Placenta Diseases; 6 are open to participants now.

This study's enrollment of 587 is above the median of 120 across 21 observational studies indexed under Placenta Diseases.

Browse Placenta Diseases studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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).

Inclusion criteria

  • singleton pregnancies
  • spontaneous pregnancies or pregnancies conceived with IVF

Exclusion criteria

Exclusion Criteria:

  • multiple pregnancies
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
587 participants (actual)
Patient registry
No

Groups and cohorts

  • spontaneous pregnancies

    Diagnostic Test: ultrasound according routine antenatal care

  • pregnancies arising through IVF (homologus + hetereologus)

    Diagnostic Test: ultrasound according routine antenatal care

Interventions

  • Diagnostic testultrasound according routine antenatal care

    ultrasound examinations at 11-14, 19-22 and 33-35 weeks

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What researchers measure

Primary outcomes

  1. type of placental and umbilical cord abnormalities

    to identify which type of placental and umbilical cord abnormalities are more common in IVF singleton pregnancies

    Time frame: 8 months

  2. heterologous fertilization

    to investigate if heterologous fertilization is an additional risk factor for the development of these abnormalities

    Time frame: 8 months

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Study locations

1 site
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, 40138, Italy
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References and documents

Individual participant data

Plan to share: Undecided — we could share all IPD that underlie results in a publication

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05172674
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Sponsor
First posted
Dec 29, 2021
Start date
May 1, 2019
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
Feb 14, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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