Mid-trimester two-dimensional transvaginal sonographic cervical consistency index for prediction of spontaneous preterm birth in singleton pregnancy

Completed

• Conditions: Prediction of spontaneous preterm birth in singleton pregnant women aged 18 years or older between 18+0 and 24+0 weeks of gestation; Preterm birth, Cervical consistency index, Ultrasonography

• Registration Number: TCTR20230807001
• Lead Sponsor: Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University

Brief Summary

In singleton pregnant women, a CCI less than or equal to 71.34% obtained by two-dimensional transvaginal sonography between 18+0 and 24+0 weeks of gestation can serve as a predictor of sPTB before 37+0 weeks. The performance of CCI to predict sPTB before 37+0 and 34+0 weeks of gestation is superior to CL, demonstrated by AUC analysis.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-18
• Study Start: 2023-08-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 185

Inclusion Criteria

1. Singleton pregnant women between 18+0 and 24+0 weeks of gestation who attend the routine ultrasound examination for fetal anomaly scan at the antenatal clinic of Srinagarind Hospital, Khon Kaen University (KKU), 2. Signed the informed consent forms

Exclusion Criteria

1. Multiple pregnancy, 2. History of spontaneous preterm birth, 3. History of cervical conization or Mullerian anomaly, 4. Receive preterm birth prophylaxis treatment (progesterone, cervical cerclage or cervical pessary) before the routine second-trimester scan, 5. Labor pain, ongoing vaginal bleeding or amniotic fluid leakage detected before the routine second-trimester scan

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cervical consistency index (CCI) cutoff delivery before 37 weeks of gestation anteroposterior (AP) diameter of cervix after cervical compression divided by AP diameter before compression

Secondary Outcome Measures

Name	Time	Method
CCI cutoff delivery before 34 weeks of gestation anteroposterior (AP) diameter of cervix after cervical compression divided by AP diameter before compression,Cervical length (CL) cutoff delivery before 37 weeks of gestation transvaginal ultrasonographic cervical length (CL) measurement,Cervical length cutoff delivery before 34 weeks of gestation transvaginal ultrasonographic cervical length measurement