PLACE2102: The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies

Sponsor

Tianjin Central Hospital of Gynecology Obstetrics (Other)

Overall Status

Recruiting

CT.gov ID

NCT06141213

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational study aims to recruit pregnant women between 18 to 24 weeks of gestation to investigate the relationship between amniotic membrane thickness and fetal chromosomal abnormalities. The primary objectives are to establish whether a correlation exists between the measured thickness of the amniotic membrane and the presence of chromosomal abnormalities in the fetus, and to determine a cutoff value for amniotic membrane thickness that could indicate an increased risk of such abnormalities. Additionally, the study seeks to assess whether the inclusion of amniotic membrane thickness as a biomarker can enhance the detection rate of non-invasive prenatal testing (NIPT) and nuchal translucency (NT) for chromosomal abnormalities.

Condition or Disease	Intervention/Treatment	Phase
Chromosome Aberrations	Diagnostic Test: Ultrasound screening

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Normal fetal chromosomes This group will consist of participants with confirmed normal fetal chromosomes. Fetal membrane thickness measurements will be taken at enrollment and may be followed up with subsequent measurements throughout the pregnancy. The data from this group will serve as the control for comparison with the chromosomal abnormality group.	Diagnostic Test: Ultrasound screening Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.
Abnormal fetal chromosomes This group will include participants whose fetuses have been diagnosed with chromosomal abnormalities. These participants will also have their fetal membrane thickness measured at the same gestational age as the control group to ensure consistency. The comparison of fetal membrane thickness between this group and the control group will be a primary focus of the study.	Diagnostic Test: Ultrasound screening Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.

Arm

Intervention/Treatment

Normal fetal chromosomes

This group will consist of participants with confirmed normal fetal chromosomes. Fetal membrane thickness measurements will be taken at enrollment and may be followed up with subsequent measurements throughout the pregnancy. The data from this group will serve as the control for comparison with the chromosomal abnormality group.

Diagnostic Test: Ultrasound screening

Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.

Abnormal fetal chromosomes

This group will include participants whose fetuses have been diagnosed with chromosomal abnormalities. These participants will also have their fetal membrane thickness measured at the same gestational age as the control group to ensure consistency. The comparison of fetal membrane thickness between this group and the control group will be a primary focus of the study.

Diagnostic Test: Ultrasound screening

Ultrasound screening for fetal membrane thickness at 18-24 weeks of pregnancy.

Outcome Measures

Primary Outcome Measures

Correlation Between Fetal Membrane Thickness and Chromosomal Abnormalities [March, 2024]
The difference in mean fetal membrane thickness between the normal and abnormal chromosomal groups, and the establishment of a threshold value for risk assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Singleton pregnant women between 18-24 weeks of gestation.
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.

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.
Participants who provided written informed consent for amniocentesis.

Exclusion Criteria:

Women with multiple pregnancies or higher-order births.
Previous chorionic villus sampling or amniocentesis in the current pregnancy.
Gestational age at the time of amniocentesis greater than 25 weeks or less than 18 weeks.
Presence of amniotic band syndrome.
The presence of uterine anomalies or conditions may impact ultrasound measurements' reliability.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Central Hospital of Obstetrics and Gynecology	Tianjin	Tianjin	China	300100

Sponsors and Collaborators

Tianjin Central Hospital of Gynecology Obstetrics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tianjin Central Hospital of Gynecology Obstetrics

ClinicalTrials.gov Identifier:

NCT06141213

Other Study ID Numbers:

PLACE2102

First Posted:

Nov 21, 2023

Last Update Posted:

Nov 21, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tianjin Central Hospital of Gynecology Obstetrics

Fetal membrane, Fetal chromosomal abnormalities, Ultrasound screening

Additional relevant MeSH terms:

Aneuploidy

Chromosome Aberrations

Study Results

No Results Posted as of Nov 21, 2023