What side effects are associated with this type of intervention?

Common treatments during pregnancy, such as noninvasive prenatal testing (NIPT), generally have minimal side effects, primarily involving minor discomfort from blood draws. For labor induction, misoprostol can cause uterine hyperstimulation, gastrointestinal discomfort, and, in rare cases, urgent cesarean delivery due to fetal distress. Oxytocin, used to control blood loss during cesarean sections, may lead to nausea and, in some cases, excessive uterine contractions. Hydroxyurea, used in sickle cell disease, is typically discontinued during pregnancy due to potential risks, although limited data suggest it may not be teratogenic. Overall, these treatments are considered safe but should be monitored for potential side effects.

What prior FDA approvals exist?

The FDA has approved several noninvasive prenatal testing (NIPT) methods that analyze cell-free fetal DNA in maternal blood to screen for chromosomal abnormalities such as trisomy 21 (Down syndrome), trisomy 18, and trisomy 13. These tests, such as those involving cell-free DNA analysis, provide a safer alternative to invasive procedures like amniocentesis. Additionally, treatments like artemisinin-based combination therapy (ACT) for malaria during pregnancy have been studied and suggested for use based on safety data, although not directly related to NIPT, they reflect the FDA's focus on safe and effective treatments during pregnancy.

What other types of research exist?

Promising novel alternatives to maternal blood sample collection and analysis for pregnancy patients in 2024 include: 1) Enhanced cell-based NIPT, which involves improved methods for recovering and analyzing fetal cells from maternal blood, potentially increasing accuracy and reducing false positives. 2) Noninvasive preimplantation genetic testing (niPGT), which utilizes spent embryo culture medium and blastocoel fluid to test for genetic abnormalities without the need for invasive procedures. These advancements aim to provide safer, more accurate, and less invasive options for prenatal genetic testing.

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Cell-Based NIPT

Cell-Based Noninvasive Prenatal Testing for Pregnancy (NIPT Trial)

N/A

Recruiting

Led By Arthur Beaudet, MD

Research Sponsored by Luna Genetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

65 or younger

Must not have

Acute illness

Recent exposure to or Active Covid-19

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve noninvasive prenatal testing by analyzing fetal cells from the blood of healthy pregnant women. Blood samples will be collected from participants across the United States, and personal identifiers will be removed to ensure privacy.

Who is the study for?

This trial is for healthy pregnant women aged between 18 and 65 in the United States. Participants must be able to provide at least a 30 ml blood sample and speak English. Women with higher order multiple pregnancies, under age 18 or over age 65, those recently exposed to or with active COVID-19, or acute illness cannot participate.

What is being tested?

The study aims to develop new methods for noninvasive prenatal testing by analyzing fetal cells from the mother's blood. Blood samples will be collected by a phlebotomist who can visit any location within the US, ensuring privacy as identifiers are removed before analysis.

What are the potential side effects?

Since this trial involves only drawing blood from participants without administering any drugs or interventions, there are minimal side effects expected beyond common blood draw reactions such as bruising or slight bleeding at the puncture site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am 65 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing a sudden illness.

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I currently have or recently had COVID-19.

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I am either younger than 18 or older than 65.

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I am either younger than 18 or older than 65.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of fetal cells recovered and quality of DNA data on each cell

Other study objectives

Control samples

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Analysis of blood samples from healthy pregnant womenExperimental Treatment1 Intervention

Analysis of blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood sample. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers. No information will go back to patients or their physicians.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Redraw for analysis of blood samples from healthy pregnant women

2020

N/A

~160

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Noninvasive prenatal testing (NIPT) involves analyzing fetal cells or cell-free fetal DNA (cffDNA) present in the maternal blood to screen for genetic conditions. The primary mechanism of action is the extraction and examination of these fetal components without the need for invasive procedures like amniocentesis or chorionic villus sampling, which carry risks of miscarriage. This matters for pregnant patients as it provides a safer, less stressful option for early detection of potential genetic abnormalities, allowing for informed decision-making and better prenatal care.

Prenatal Management of Pregnancies at Risk of Fetal Neonatal Alloimmune Thrombocytopenia (FNAIT): Scientific Impact Paper No. 61.Use of biochemical tests of placental function for improving pregnancy outcome.Maternal obesity and metabolic risk to the offspring: why lifestyle interventions may have not achieved the desired outcomes.