Predicting preterm delivery using cervical length measurements
Serial Cervical Length Measurements After the 1st Episode of Threatened Preterm Labor to Improve Prediction of Spontaneous Preterm Delivery: Prospective Cohort Study
This study is testing if measuring the length of the cervix in pregnant women at risk of preterm labor can help predict if they will deliver their baby early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 303 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Modena and Reggio Emilia Academic / other |
| Locations | 6 sites (Ancona and 5 other locations) |
| Trial ID | NCT05044143 on ClinicalTrials.gov |
What this trial studies
This observational study involves pregnant women who have experienced a first episode of threatened preterm labor. Cervical length will be measured using transvaginal ultrasound at various intervals, starting from the time of hospital admission and continuing for up to 12 weeks. The study aims to explore the relationship between changes in cervical length and the timing of delivery, specifically to determine if cervical shortening can predict spontaneous preterm delivery. Participants will be women with a cervical length of less than 25 mm upon discharge from the hospital.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged over 18 years with a singleton pregnancy between 23 and 33 weeks of gestation who can provide consent.
Not a fit: Patients with a history of previous spontaneous preterm delivery or those with multiple pregnancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help predict preterm delivery, allowing for better management and care of at-risk pregnancies.
How similar studies have performed: While the approach of monitoring cervical length has been explored in other studies, the specific methodology and focus on threatened preterm labor in this context may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton pregnancy at 23+0 - 33+6 weeks' gestation * Age \> 18 years old * Patients should be capable of providing consent to participate in the study Exclusion Criteria: * Previous spontaneous preterm (20+0 - 36+6 weeks' gestation) delivery (including history of pregnancy loss due to cervical incompetence, i.e painless cervical dilatation prior to 24 weeks' gestation) * Treatment with 17 hydroxyprogesterone caproate due to a previous spontaneous preterm delivery * Detection of a cervical length \< 25 mm during routine ultrasound \< 24 weeks' gestation in asymptomatic patients (i.e patients that do not complain of uterine contractions or patients with no uterine contractions documented on tocometry) * Treatment with vaginal progesterone or micronized progesterone due to a cervical length \< 25 mm * Cerclace placement in the current or in a previous pregnancy * Multiple pregnancy * Age \< 18 years old * Preterm premature rupture of membranes (pPROM) upon initial presentation * Müllerian malformations * Prior cervical surgery
Where this trial is running
Ancona and 5 other locations
- Facoltà di Medicina e Chirurgia, università politecnica delle Marche — Ancona, Italy (Recruiting)
- Mariarosaria Di Tommaso, Divisione di Ginecologia ed Ostetricia, Dipartimento Assistenziale Integrato Materno Infantile, Azienda Ospedaliero-Universitaria Careggi — Firenze, Italy (Recruiting)
- Divisione di Ginecolgia ed stetricia, Azienda Ospedaliera Vimercate-Desio presidio di Carate Brianza Giussano, e Università di Milano Bicocca — Milan, Italy (Recruiting)
- Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Clinica Mangiagalli, Università di Milano — Milan, Italy (Recruiting)
- Department of Obstetrics and Gynecology, Foundation MBBM at San Gerardo Hospital, University of Milan-Bicocca School of Medicine and Surgery — Monza, Italy (Recruiting)
- Divisione di Ginecologia ed Ostetricia, Dipartimento Materno infantile, Arcispedale Santa Maria Nuova, IRCCS — Reggio Emilia, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Chiossi, MD — Dept of Ob/Gyn, Modena Policlinico Hospital, University of Modena and Reggio Emilia
- Study coordinator: Giuseppe Chiossi, MD
- Email: ossidi74seppie@yahoo.it
- Phone: +39 059/4225437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.