Cervical Softening and the Prediction of Preterm Birth
STIPP
Assessment of Cervical SofTening and the Prediction of Preterm Birth'
1 other identifier
observational
390
1 country
1
Brief Summary
Currently, transvaginal cervical length measurement is used to screen in asymptomatic pregnant women with a history of PTB. In symptomatic women, presenting with threatened PTB cervical length in combination with the fibronectin test is used to identify women at high risk to deliver preterm. However, the predictive capacity of transvaginal cervical length measurement is limited. In pregnant women with a history of PTB, it only identifies a proportion of women who will have recurrent PTB. For symptomatic women, 30-60% of these women admitted to the hospital, do not deliver within seven days, leading to overtreatment of these women. Cervical softening is precursor of cervical shortening, effacement and dilatation and therefore cervical softening is a promising new marker that is based on tissue elasticity. However, the predictive value of cervical softening and the relation with spontaneous PTB still has to be determined. With the newly developed Pregnolia® System cervical softness could be measured on a standardized and safe manner. This study could help to improve care for women with a history of spontaneous PTB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
August 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 5, 2023
August 1, 2023
2 years
July 19, 2022
August 30, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Spontaneous Preterm Birth < 34 weeks
Spontaneous preterm birth before 34 weeks of gestation in the asymptomatic cohort
Maximum time frame up to 28 weeks: from inclusion at 14 weeks of gestational age until delivery, with a maximum of 42 weeks of gestational age.
Delivery within seven days after inclusion
Delivery within seven days after inclusion in the symptomatic cohort
From inclusion until 7 days later
Secondary Outcomes (10)
Spontaneous preterm birth <37 weeks
From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Spontaneous preterm birth <34 weeks
From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Spontaneous preterm birth <32 weeks
From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Spontaneous preterm birth <28 weeks
From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of preterm birth using cervical softening.
From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
- +5 more secondary outcomes
Other Outcomes (6)
Patient discomfort of Pregnolia measurement
In asymptomatic cohort at 14, 16, 18, 20, 22 and 24 weeks of gestational age, in the symptomatic cohort at moment of inclusion
Vaginal or Cervical blood loss (directly after measurement)
In asymptomatic cohort at 14, 16, 18, 20, 22 and 24 weeks of gestational age, in the symptomatic cohort at moment of inclusion
Infections within seven days of measurement
From inclusion up to 1 week
- +3 more other outcomes
Study Arms (2)
Asymptomatic women with a history of preterm birth
Pregnant women \>18 years of age, with a history of spontaneous PTB before 34 weeks. All women have biweekly visits for routine transvaginal cervical length measurement between 14-24 weeks of gestation. During these visits data on cervical softening will be collected as additional marker.
Symptomatic women with symptoms of threatened preterm birth
Pregnant women \>18 years of age, between 24 and 34 weeks of gestation, presenting with symptoms of threatened Preterm birth (e.g. abdominal pain, blood loss, contractions, or other complaints suggestive for threatened Preterm birth).
Interventions
The Pregnolia® System is designed to provide information about the mechanical properties of the cervical tissue by assessing the CSI (Cervical Stiffness Index) through a probe that will create a weak vacuum to retract tissue. The Pregnolia® System is designed with the purpose to provide an alternative diagnostic marker to identify women at risk of spontaneous PTB. The Pregnolia® System is a CE-marked device developed for quantitative assessment of softening of the uterine cervix. The Pregnolia® System will be applied within its intended use.
Eligibility Criteria
Women with an increased risk of preterm birth. Women are eligible when they fall in one of following categories: * Medical History of Spontaneous Preterm Birth before 34 weeks of gestation or * Threatened Preterm Birth between 24 and 34 weeks of gestation
You may qualify if:
- 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.
- Cohort A-STIPP specific:
- \- Medical history of spontaneous preterm birth before 34 weeks of gestation
- Cohort S-STIPP specific:
- Threatened Preterm birth between 24 and 34 weeks of gestation.
- Threatened preterm birth is defined as:
- abdominal pain
- (Braxton Hicks) contractions
- vaginal blood loss.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ, Netherlands
Related Publications (1)
Breuking S, Oudijk MA, van Eekelen R, de Boer MA, Pajkrt E, Hermans F. Assessment of cervical softening and the prediction of preterm birth (STIPP): protocol for a prospective cohort study. BMJ Open. 2023 Nov 21;13(11):e071597. doi: 10.1136/bmjopen-2023-071597.
PMID: 37989370DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Pajkrt, Prof. Dr.
Amsterdam UMC, location AMC
- PRINCIPAL INVESTIGATOR
Martijn Oudijk, Prof. Dr.
Amsterdam UMC, location AMC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. M.A.Oudijk
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 28, 2022
Study Start
August 18, 2022
Primary Completion
September 1, 2024
Study Completion
December 1, 2024
Last Updated
September 5, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- After publication of the manuscript
- Access Criteria
- Data are available upon reasonable request
All agreements regarding data sharing are defined in a signed Clinical Trial Agreement (CTA), GDPR are applicable to this agreement.