Investigating the link between fetal membrane thickness and chromosomal abnormalities in fetuses

The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies

This study is trying to see if measuring the thickness of the amniotic membrane in pregnant women can help identify the risk of chromosomal problems in their babies.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Tianjin Central Hospital of Gynecology Obstetrics (Academic / other)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06141213 on ClinicalTrials.gov

What this trial studies

This observational study aims to recruit pregnant women between 18 to 24 weeks of gestation to explore the relationship between the thickness of the amniotic membrane and fetal chromosomal abnormalities. The study will assess whether there is a correlation between membrane thickness and the presence of chromosomal anomalies, and it seeks to establish a cutoff value for thickness that may indicate increased risk. Additionally, the research will evaluate if incorporating amniotic membrane thickness as a biomarker can improve the detection rates of non-invasive prenatal testing (NIPT) and nuchal translucency (NT) screenings for chromosomal issues.

Who should consider this trial

Good fit: Ideal candidates for this study are singleton pregnant women between 18 to 24 weeks of gestation with high-risk indications for fetal chromosomal abnormalities.

Not a fit: Patients with multiple pregnancies or those who have undergone previous chorionic villus sampling or amniocentesis in the current pregnancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance prenatal screening methods, leading to earlier and more accurate detection of chromosomal abnormalities in fetuses.

How similar studies have performed: While this approach is innovative, similar studies have shown varying degrees of success in correlating ultrasound findings with chromosomal abnormalities.

Eligibility criteria

Inclusion Criteria:

1. Singleton pregnant women between 18-24 weeks of gestation.
2. Participants with high-risk indications for prenatal fetal chromosomal abnormalities, including:

   * Nuchal translucency (NT) ≥ 3 mm.
   * High-risk results from non-invasive prenatal testing (NIPT) using cell-free fetal DNA from peripheral maternal blood.
   * Ultrasound-detected fetal abnormalities.
   * Other indicators include adverse birth histories, parental chromosomal abnormalities, familial diseases, and a history of thyroid cancer post-surgery.
3. Gestational age and estimated due date were confirmed by the first day of the last menstrual period and adjusted using fetal crown-rump length measured during the first-trimester ultrasound scan.
4. Participants who provided written informed consent for amniocentesis.

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Exclusion Criteria:

1. Women with multiple pregnancies or higher-order births.
2. Previous chorionic villus sampling or amniocentesis in the current pregnancy.
3. Gestational age at the time of amniocentesis greater than 25 weeks or less than 18 weeks.
4. Presence of amniotic band syndrome.
5. The presence of uterine anomalies or conditions may impact ultrasound measurements' reliability.
6. Any medical condition or obstetric complication that, in the opinion of the investigators, might pose a risk to the participant or interfere with the study outcomes.

Where this trial is running

Tianjin, Tianjin

• Tianjin Central Hospital of Obstetrics and Gynecology — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Jiasong Cao, PhD

Conditions Chromosome Aberrations; Fetal membrane, Fetal chromosomal abnormalities, Ultrasound screening