NCT06081556

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 256 (actual)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Recurrent Spontaneous Abortion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: China