Multimodal ultrasound for the evaluation of cervical remodeling during pregnancy and its application in the prediction of spontaneous preterm birth

Status

Recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300072342

Enrollment

Unknown

Registered

2023-06-10

Start date

2023-06-10

Completion date

Unknown

Last updated

2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm birth

Interventions

study group 1:none

study group 2:none

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Study group 1: pregnant women with high risk factors of premature delivery. Inclusion criteria for study group 1: 1.Pregnant women at 11-14 weeks of gestation; 2.Pregnant women with high risk of premature delivery include: (1)Those with late abortion and / or premature delivery history; (2)Vaginal ultrasound examination: the cervical length found by vaginal ultrasound in the second trimester of pregnancy is less than 25 mm; (3)Those with a history of cervical surgery; (4)Those who are too young or too old: pregnant women 35 years old; (5)Those who have too short pregnancy interval (less than 6 months); (6)Those who have too thin body mass index < 19 kg / m^2, or the weight of pregnancies is less than 50kg; (7)Multiple pregnancies; (8)Assisted reproductive technology; (9)Abnormal fetal and amniotic fluid volume; (10)Pregnancy complications or complications; (11)Bad habits such as tobacco and alcohol. 3.Sign informed consent. Study group 2: pregnant women without high risk of premature delivery. Inclusion criteria for study group 2: 1.Normal singleton pregnant women excluding high risk factors, pregnant 11-14 weeks; 2.Sign informed consent.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: 1.Suffering from diseases unfavorable to the trial or threatening other participants, such as mental diseases; 2.Unable to cooperate with test operation; 3.The quality of ultrasonic image is poor, which can not meet the requirements of parameter measurement and analysis; 4.Congenital malformation of fetus; 5.Pregnant women who cannot obtain pregnancy outcome; 6.Iatrogenic premature delivery or induced labor; 7.The basic information is incomplete.

Design outcomes

Primary

Measure	Time frame
elasticity contrast index;internal ostium(IOS)/external ostium(EOS);hardness ratio(HR);cervix length;cervix volume;uterus-cervix angle;internal ostium(IOS);	—

Countries

China

Contacts

Public ContactZhou yimin

Women's Hospital, Zhejiang University School of Medicine

zhou1min@zju.edu.cn+86 138 6745 9010

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026