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Placental Function Assessment for High-Risk Pregnancies

Phase 1
Waitlist Available
Led By Eileen P. Sloan, MD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Over 18 years of age
Normal karyotype
Must not have
Abnormal karyotype
Currently suffering from a major psychiatric illness or current use of psychotropic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether or not reducing anxiety in high-risk pregnant women through blood tests and ultrasounds improves outcomes for mother and child.

Who is the study for?
This trial is for pregnant women over 18, fluent in English, with high-risk pregnancies due to conditions like diabetes or high blood pressure. They must be patients at Mount Sinai Hospital's maternal/fetal unit without major fetal abnormalities or genetic issues and able to consent.
What is being tested?
The study tests if assessing placental function through blood tests and ultrasound can reduce anxiety in these women by reassuring them about their baby's health. Half the participants will receive this assessment randomly while the other half won't, to measure any differences accurately.
What are the potential side effects?
There are no direct side effects from the placental function assessment itself as it involves standard pregnancy blood tests and an ultrasound which are routine procedures during prenatal care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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My chromosomes are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My genetic test shows abnormal chromosomes.
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I am currently dealing with a major psychiatric condition or taking medication for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Active Control
Group I: Active groupActive Control1 Intervention
Receive assessment of placental function

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
204 Previous Clinical Trials
69,037 Total Patients Enrolled
Ontario Mental Health FoundationOTHER_GOV
23 Previous Clinical Trials
3,214 Total Patients Enrolled
Eileen P. Sloan, MDPrincipal InvestigatorMount Sinai Hospital, Canada

Media Library

Placental Function Assessment Clinical Trial Eligibility Overview. Trial Name: NCT00546026 — Phase 1
Pregnancies Research Study Groups: Active group
Pregnancies Clinical Trial 2023: Placental Function Assessment Highlights & Side Effects. Trial Name: NCT00546026 — Phase 1
Placental Function Assessment 2023 Treatment Timeline for Medical Study. Trial Name: NCT00546026 — Phase 1
~107 spots leftby Jan 2026
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