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COMPLETED
NCT05044143

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

Sponsor: University of Modena and Reggio Emilia

View on ClinicalTrials.gov

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.

Official title: Serial Cervical Length Measurements After the 1st Episode of Threatened Preterm Labor to Improve Prediction of Spontaneous Preterm Delivery: Prospective Cohort Study

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

OBSERVATIONAL

Enrollment

303

Start Date

2021-10-20

Completion Date

2024-12-28

Last Updated

2026-05-26

Healthy Volunteers

Not specified

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).

Locations (6)

Facoltà di Medicina e Chirurgia, università politecnica delle Marche

Ancona, Italy

Mariarosaria Di Tommaso, Divisione di Ginecologia ed Ostetricia, Dipartimento Assistenziale Integrato Materno Infantile, Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Divisione di Ginecolgia ed stetricia, Azienda Ospedaliera Vimercate-Desio presidio di Carate Brianza Giussano, e Università di Milano Bicocca

Milan, Italy

Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Clinica Mangiagalli, Università di Milano

Milan, Italy

Department of Obstetrics and Gynecology, Foundation MBBM at San Gerardo Hospital, University of Milan-Bicocca School of Medicine and Surgery

Monza, Italy

Divisione di Ginecologia ed Ostetricia, Dipartimento Materno infantile, Arcispedale Santa Maria Nuova, IRCCS

Reggio Emilia, Italy