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Completed

NCT Number: 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

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Serum blood test

Primary outcomes

  1. The pregnancy outcome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Acronym: mGSD-CRL& RSA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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