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

Sponsor
The First Affiliated Hospital of Xiamen University (Other)
Overall Status
Completed
CT.gov ID
NCT06081556
Collaborator
(none)
256
1
38.9
6.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultrasonic testing

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
256 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Difference Between Mean Gestational Sac Diameter and Crown-rump Length as a Marker of First-trimester Pregnancy Outcome in Patients With Recurrent Spontaneous Abortion
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Mar 30, 2023
Actual Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Group A

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

Diagnostic Test: 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
Other Names:
  • Serum blood test
  • Group B

    10 mm < mGSD-CRL ≤ 15 mm

    Diagnostic Test: 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
    Other Names:
  • Serum blood test
  • Group C

    mGSD-CRL >15 mm

    Diagnostic Test: 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
    Other Names:
  • Serum blood test
  • Outcome Measures

    Primary Outcome Measures

    1. The pregnancy outcome [The 14 weeks of pregnancy]

      The pregnancy outcome at 14 weeks was considered successful if a visible embryo and cardiac activity were confirmed via ultrasound, whereas it was considered a failure if abortion or no cardiac activity was confirmed in the gestational sac by ultrasound.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Xiamen University Xiamen Fujian China 361003

    Sponsors and Collaborators

    • The First Affiliated Hospital of Xiamen University

    Investigators

    • Study Chair: Jing Ran, Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital of Xiamen University
    ClinicalTrials.gov Identifier:
    NCT06081556
    Other Study ID Numbers:
    • yanlingwork
    • 81601284
    First Posted:
    Oct 13, 2023
    Last Update Posted:
    Oct 13, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The First Affiliated Hospital of Xiamen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2023