Difference Between Mean Gestational Sac Diameter and Crown-rump Length as a Marker of First-trimester Pregnancy Outcome in Patients With Recurrent Spontaneous Abortion

NCT ID: NCT06081556

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

256 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-03-30

Brief Summary

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Objective: To determine the effect and predictive value of the difference between the mean gestational diameter (mGSD) sac and crown-rump length (CRL) of the first trimester on the pregnancy outcomes of patients with recurrent spontaneous abortion (RSA).Methods: This is a retrospective cohort study. In total, 256 pregnant women at 6-10 weeks of gestation and with RSA who visited our hospital from January 2020 to March 2023 were included in the study. They were divided into the following three groups based on the difference between the mGSD and CRL (mGSD-CRL): Group A: mGSD-CRL ≥ 10mm, 41 cases; Group B: 10mm \< mGSD-CRL ≤ 15mm, 109 cases; and Group C: mGSD-CRL \> 15mm, 106 cases.

Detailed Description

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Study question: Can the difference between mean gestational sac diameter and crown-rump length (mGSD-CRL) act as a marker of first-trimester pregnancy outcome in patients with recurrent spontaneous abortion (RSA)? Summary answer: In patients with RSA, mGSD-CRL acts as an independent risk factor affecting pregnancy outcomes, as it can effectively predict the early pregnancy outcomes of patients with RSA.

What is known already: RSA refers to the occurrence of two or more consecutive miscarriages with the same partner before reaching 28 weeks of gestation, which causes considerable physical and psychological distress to the patients. Therefore, predicting the outcome of subsequent pregnancies in patients with RSA is important. Recent studies have reported a smaller mGSD-CRL difference in association with a higher rate of spontaneous abortion. In addition, thrombophilia-induced RSA has garnered increasing research attention as it is an important cause of early and late miscarriages.

Study design, size, duration: This is a retrospective cohort study. In total, 256 pregnant women at 6-10 weeks of gestation and with RSA who visited our hospital from January 2020 to March 2023 were included in the study. The patients were allocated to three groups based on the mGSD-CRL difference: Group A: mGSD-CRL ≥10 mm, Group B: 10 mm \< mGSD-CRL ≤ 15 mm, and Group C: mGSD-CRL \>15 mm.

Conditions

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Recurrent Spontaneous Abortion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

the difference between mean gestational sac diameter and crown-rump length (mGSD-CRL) ≥ 10mm

ultrasonic testing

Intervention Type DIAGNOSTIC_TEST

mean gestational sac diameter(mGSD), crown-rump length (CRL), mGSD-CRL, D-dimer (DD), adenosine diphosphate (ADP), arachidonic acid (AA), and the ratio of uterine artery peak systolic value to end-diastolic value (UtA-S/D) were collected

Group B

10 mm \< mGSD-CRL ≤ 15 mm

ultrasonic testing

Intervention Type DIAGNOSTIC_TEST

mean gestational sac diameter(mGSD), crown-rump length (CRL), mGSD-CRL, D-dimer (DD), adenosine diphosphate (ADP), arachidonic acid (AA), and the ratio of uterine artery peak systolic value to end-diastolic value (UtA-S/D) were collected

Group C

mGSD-CRL \>15 mm

ultrasonic testing

Intervention Type DIAGNOSTIC_TEST

mean gestational sac diameter(mGSD), crown-rump length (CRL), mGSD-CRL, D-dimer (DD), adenosine diphosphate (ADP), arachidonic acid (AA), and the ratio of uterine artery peak systolic value to end-diastolic value (UtA-S/D) were collected

Interventions

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ultrasonic testing

mean gestational sac diameter(mGSD), crown-rump length (CRL), mGSD-CRL, D-dimer (DD), adenosine diphosphate (ADP), arachidonic acid (AA), and the ratio of uterine artery peak systolic value to end-diastolic value (UtA-S/D) were collected

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Serum blood test

Eligibility Criteria

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Inclusion Criteria

(1) patients diagnosed with RSA based on medical history, (2) those who intend to continue the pregnancy, (3) singleton pregnancy, (4) gestational age is between 6-10 weeks, and (5) the conception for the current pregnancy was natural

Exclusion Criteria

(1) individuals with multiple pregnancies or ectopic pregnancies, (2) conception through assisted reproductive techniques, and (3) chromosomal abnormalities in pregnant women or their partners.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Ran

Role: STUDY_CHAIR

Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University

Locations

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The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status

Countries

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China

References

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Yan L, Su Y, Liao Z, Chen H, Ran J. Difference between mean gestational sac diameter and crown rump length predicts pregnancy outcome in patients with recurrent spontaneous abortion. Sci Rep. 2025 Sep 26;15(1):33010. doi: 10.1038/s41598-025-18390-3.

Reference Type DERIVED
PMID: 41006676 (View on PubMed)

Other Identifiers

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81601284

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

yanlingwork

Identifier Type: -

Identifier Source: org_study_id

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