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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cross-sectional

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am over 18 years old.

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My chromosomes are normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cross-sectional

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cross-sectional

This trial's timeline: 3 weeks for screening, Varies for treatment, and cross-sectional for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

measure is STAI - The State Trait Anxiety Inventory

Secondary outcome measures

Women who undergo the placental function assessment will deliver at a later gestation age, have less complications and stillbirths than untested women. Neonates will have higher APGAR scores at 1 and 5 minutes and less likely to be admitted to the NICU.

Trial Design

1Treatment groups

Active Control

Group I: Active groupActive Control1 Intervention

Receive assessment of placental function

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor

196 Previous Clinical Trials

67,448 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent might Active group present a hazard to those under its care?

"Our team at Power has assigned Active group a score of 1, as it is currently in Phase 1 and there is minimal evidence to support its safety or efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?

2024. "Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00546026.

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