Assessment of cervical SofTening and the Prediction of Preterm birth

Recruiting

• Conditions: preterm birth; 10026908

• Registration Number: NL-OMON51730
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 390

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

- 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Asymptomatic cohort: Spontaneous PTB before 34 weeks of gestation.<br /><br><br /><br>Symptomatic cohort: Delivery within seven days.</p><br>