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

NCT05172674 | Completed

• 1 other identifier: 20/2019/Oss/AOUBo
• Study Type: observational
• Target: 587
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Placenta Diseases; IVF

Outcome Measures

Primary Outcomes (2)

• type of placental and umbilical cord abnormalities

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

  8 months

• heterologous fertilization

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

  8 months

Study Arms (2)

spontaneous pregnancies

Diagnostic Test: ultrasound according routine antenatal care

pregnancies arising through IVF (homologus + hetereologus)

Diagnostic Test: ultrasound according routine antenatal care

Interventions

ultrasound according routine antenatal care DIAGNOSTIC_TEST

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

pregnancies arising through IVF (homologus + hetereologus); spontaneous pregnancies

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• singleton pregnancies
• spontaneous pregnancies or pregnancies conceived with IVF

You may not qualify if:

• multiple pregnancies

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Placenta Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 29, 2021
• Study Start: May 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-01

Locations

IT (1)