Difference Between Mean Gestational Sac Diameter and Crown-rump Length as a Marker of First-trimester Pregnancy Outcome in Patients With Recurrent Spontaneous Abortion
- Conditions
- Recurrent Spontaneous Abortion
- Interventions
- Diagnostic Test: ultrasonic testing
- Registration Number
- NCT06081556
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 256
(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
(1) individuals with multiple pregnancies or ectopic pregnancies, (2) conception through assisted reproductive techniques, and (3) chromosomal abnormalities in pregnant women or their partners.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group A ultrasonic testing the difference between mean gestational sac diameter and crown-rump length （mGSD-CRL） ≥ 10mm Group C ultrasonic testing mGSD-CRL \>15 mm Group B ultrasonic testing 10 mm \< mGSD-CRL ≤ 15 mm
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China