Assessment of cervical SofTening and the Prediction of Preterm birth

Assessment of cervical SofTening and the Prediction of Preterm birth - STIPP study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51730

Enrollment

390

Registered

2022-03-25

Start date

2022-08-17

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

preterm birth

Interventions

Procedure of Pregnolia® System: The procedure is equal for both cohorts and consists of speculum placement and&nbsp

measurement of cervical softening with the CE-marked Pregnolia® System for&nbsp

accurate characterization of cervical softening. The procedure is completed&nbsp

within 75 seconds and is pain free and harmless&nbsp

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age 18 years or above. - Ability to understand Dutch or English (both spoken and written). - Ultrasound-based gestational age determined by measurement of crown rump length (CRL) determined between 9 and 11 weeks of gestation. - Singleton and twin pregnancies. - Medical history of spontaneous PTB before 34 weeks of gestation OR Threatened PTB between 24 and 34 weeks of gestation.

Exclusion criteria

Exclusion criteria: - Under 18 years of age. - Signs of intrauterine infection. - Obstetric indication for immediate delivery (advanced labor, cord prolapse, abruption, signs of fetal distress). - Confirmed fetal abnormality. - Confirmed preterm rupture of membranes. - Confirmed vasa / placenta praevia. - Severe vaginal bleeding and light bleeding that cannot be stopped. - Signs of imminent labor such as blood loss, regular contractions.

Design outcomes

Primary

Measure	Time frame
Asymptomatic cohort: Spontaneous PTB before 34 weeks of gestation. Symptomatic cohort: Delivery within seven days.	—

Secondary

Measure	Time frame
1. Evaluate the diagnostic value and accuracy of the combination of cervical softening and transvaginal cervical length measurement* to predict PTB before 34 weeks of gestation or delivery within seven days. 2. Evaluate the diagnostic value and accuracy of cervical softening to predict PTB before; - 37 weeks of gestation - 34 weeks of gestation - 32 weeks of gestation - 28 weeks of gestation 3. Evaluate the diagnostic value and accuracy of the combination of cervical softening and transvaginal cervical length* measurement to predict PTB before; - 37 weeks of gestation - 34 weeks of gestation - 32 weeks of gestation - 28 weeks of gestation 4. Evaluate the diagnostic value and accuracy of cervical softening to predict latency time (interval between inclusion and delivery in days) 5. Evaluate the diagnostic value and accuracy of the combination of cervical softening and transvaginal cervical length measurement* to predict latency time (interval between inclusion and delivery in days) 6. To create a prediction model to optimally predict spontaneous PTB before 34 or delivery within seven days with the use of the following predictors (in hierarchical order): - Cervical stiffness index - Transvaginal cervical length - Fetal Fibronectin# - Twin gestation - Severity of previous spontaneous PTB - Cervical surgery - Inter-pregnancy interval - Urinary tract infection - Family history - Social economic status - Smoking - BMI	—

Measure

Time frame

1. Evaluate the diagnostic value and accuracy of the combination of cervical softening and transvaginal cervical length measurement* to predict PTB before 34 weeks of gestation or delivery within seven days. 2. Evaluate the diagnostic value and accuracy of cervical softening to predict PTB before; - 37 weeks of gestation - 34 weeks of gestation - 32 weeks of gestation - 28 weeks of gestation 3. Evaluate the diagnostic value and accuracy of the combination of cervical softening and transvaginal cervical length* measurement to predict PTB before; - 37 weeks of gestation - 34 weeks of gestation - 32 weeks of gestation - 28 weeks of gestation 4. Evaluate the diagnostic value and accuracy of cervical softening to predict latency time (interval between inclusion and delivery in days) 5. Evaluate the diagnostic value and accuracy of the combination of cervical softening and transvaginal cervical length measurement* to predict latency time (interval between inclusion and delivery in days) 6. To create a prediction model to optimally predict spontaneous PTB before 34 or delivery within seven days with the use of the following predictors (in hierarchical order): - Cervical stiffness index - Transvaginal cervical length - Fetal Fibronectin# - Twin gestation - Severity of previous spontaneous PTB - Cervical surgery - Inter-pregnancy interval - Urinary tract infection - Family history - Social economic status - Smoking - BMI

—

Countries

Netherlands

Contacts

Public ContactM.A. Oudijk

Amsterdam UMC

stipp@amsterdamumc.nl0205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)