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

NCT05044143 | Unknown

• 1 other identifier: Università di Modena
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• To investigate the association between cervical length measured at different time points and the risk of spontaneous preterm birth < 37 weeks' gestation

  The risk of spontaneous preterm birth \< 37 weeks' gestation will be compared among women with at least a cervical length \< 10 mm as opposed to those whose cervix will remain persistently \> 10 mm. A relationship between gestational age at delivery and cervical length will also be investigate considering the two variables as continuous

  At the time of delivery

Secondary Outcomes (2)

• To assess a possible association between cervical length and adverse neonatal outcomes

  At the time of delivery

• To assess a possible association between cervical length and adverse maternal outcomes.

  At the time of delivery

Study Arms (1)

Women who remained undelivered after their first episode of threatened preterm labor

Women admitted to the hospital due to their first episode of threatened preterm labor (i.e onset of spontaneous labor \< 34 weeks gestation), who did not deliver prematurely as labor stopped (with or without interventions such as tocolysis). Those with a cervical length \< 25 mm at the time of hospital discharge are eligible to participate in the study

Other: Monitoring the length of the uterine cervix using transvaginal ultrasound

Interventions

Monitoring the length of the uterine cervix using transvaginal ultrasound OTHER

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).

Women who remained undelivered after their first episode of threatened preterm labor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The study will be conducted on pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who remained undelivered after their first episode of threatened preterm labor, whose cervical length upon hospital discharge is \< 25 mm

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (6)

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

Florence, 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

Related Publications (25)

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• Berghella V, Palacio M, Ness A, Alfirevic Z, Nicolaides KH, Saccone G. Cervical length screening for prevention of preterm birth in singleton pregnancy with threatened preterm labor: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):322-329. doi: 10.1002/uog.17388. Epub 2017 Feb 8.

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• Society for Maternal-Fetal Medicine Publications Committee, with assistance of Vincenzo Berghella. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012 May;206(5):376-86. doi: 10.1016/j.ajog.2012.03.010.

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• Chiossi G, Facchinetti F, Vergani P, Di Tommaso M, Marozio L, Acaia B, Pignatti L, Locatelli A, Spitaleri M, Benedetto C, Zaina B, D'Amico R; PROTECT Collaborative Group. Serial cervical-length measurements after first episode of threatened preterm labor improve prediction of spontaneous delivery prior to 37 weeks' gestation. Ultrasound Obstet Gynecol. 2021 Feb;57(2):298-304. doi: 10.1002/uog.22188.

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Study Officials

• Giuseppe Chiossi, MD

  Dept of Ob/Gyn, Modena Policlinico Hospital, University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Chiossi, MD

CONTACT

+39 059/4225437; ossidi74seppie@yahoo.it

Fabio Facchinetti, MD

CONTACT

+39 059/4225437; fabio.facchinetti@unimore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 14, 2021
• Study Start: October 20, 2021
• Primary Completion: June 20, 2025
• Study Completion: December 20, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)