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

NCT06081556 | Completed

• 2 other identifiers: yanlingwork81601284
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Spontaneous Abortion

Keywords

recurrent spontaneous abortion; difference between mean gestational sac diameter and crown-rump length; thrombophilia; first-trimester pregnancy outcome

Outcome Measures

Primary Outcomes (1)

• The pregnancy outcome

  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.

  The 14 weeks of pregnancy

Study Arms (3)

Group A

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

Diagnostic Test: ultrasonic testing

Group B

10 mm \< mGSD-CRL ≤ 15 mm

Diagnostic Test: ultrasonic testing

Group C

mGSD-CRL \>15 mm

Diagnostic Test: ultrasonic testing

Interventions

ultrasonic testing 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

Also known as: Serum blood test

Group A; Group B; Group C

Eligibility Criteria

• Gender Eligibility Details: the pregnant women with recurrent spontaneous abortion
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The pregnant women with RSA who visited the First Affiliated Hospital of Xiamen University from January 2020 to March 2023

You may qualify if:

• (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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Related Publications (1)

• 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.

  PMID: 41006676 DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous; Thrombophilia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jing Ran

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 13, 2023
• Study Start: January 1, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)