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临床试验/NCT06081556
NCT06081556已完成不适用

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

The First Affiliated Hospital of Xiamen University1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
256
试验地点
1
主要终点
The pregnancy outcome

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • (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

排除标准

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

结局指标

主要结局

The pregnancy outcome

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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