Prediction of Preterm Delivery with Serial Cervical Length Measurements After Threatened Preterm Labor

NCT05044143 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 303

Last updated 2024-12-09

No results posted yet for this study

Summary

Prospective cohort study on pregnant women discharged from the hospital after the first episode of threatened preterm labor. Cervical length (CL) will be measured with transvaginal US upon initial presentation (i.e at the time of hospital admission), at the time of hospital discharge, and respectively 2, 4, 8 and 12 weeks later. Pregnant women undelivered after the 1st episode of threatened preterm labor will be invited to participate in the study if CL upon discharge is \< 25 mm. The study will investigate the potential association between cervical shortening over time and time of delivery, to assess if spontaneous preterm delivery can be predicted by CL.

Conditions

  • Preterm Labor with Preterm Delivery

Interventions

OTHER

Monitoring the length of the uterine cervix using transvaginal ultrasound

Cervical length is measured with a 7-9 MHz transvaginal probe by trained obstetricians-gynecologists following the same standardized approach (Berghella 2003). Transvaginal CL measurement is largely used in current obstetric practice, and it is considered the 'gold standard' measurement when assessing the uterine cervix. In contrast to transabdominal US, the transvaginal approach is highly reproducible, and measurements are unaffected by maternal obesity, cervical position, and shadowing from fetal parts (Berghella 2003, Hassan 2000, ACOG 2012, Berghella 2012).

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    lead OTHER

Principal Investigators

  • Giuseppe Chiossi, MD · Dept of Ob/Gyn, Modena Policlinico Hospital, University of Modena and Reggio Emilia

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2025-06-20
Completion
2025-12-20

Countries

  • Italy

Study Locations

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Read the full study record

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View NCT05044143 on ClinicalTrials.gov