Preterm Birth Clinical Trial
— STIPPOfficial title:
Assessment of Cervical SofTening and the Prediction of Preterm Birth'
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.
Status | Recruiting |
Enrollment | 390 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. 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. 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC, location AMC | Amsterdam | North-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Pregnolia AG |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient discomfort of Pregnolia measurement | Pain during Pregnolia measured on a visual analogue scale (VAS) from "no pain"to "worst possible pain" | In asymptomatic cohort at 14, 16, 18, 20, 22 and 24 weeks of gestational age, in the symptomatic cohort at moment of inclusion | |
Other | Vaginal or Cervical blood loss (directly after measurement) | Vaginal or Cervical blood loss, noticed directly (= within 30 minutes) 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 | |
Other | Infections within seven days of measurement | Infections within seven days of measurement (urinary tract infections, vaginal infections, intra-uterine infections) | From inclusion up to 1 week | |
Other | Preterm Prelabour Rupture of membranes at moment of measurement | Preterm Prelabour Rupture of membranes at moment of measurement | Within 1 hour after measurement | |
Other | Irritation and sensitization of mucosal tissue | Irritation and sensitization of mucosal tissue as noticed by the researcher performing the measurement | Within 1 hour after measurement | |
Other | Superficial lacerations or minor tissue abrasions | Superficial lacerations or minor tissue abrasions | Within 1 hour after measurement | |
Primary | 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. | |
Primary | Delivery within seven days after inclusion | Delivery within seven days after inclusion in the symptomatic cohort | From inclusion until 7 days later | |
Secondary | Spontaneous preterm birth <37 weeks | Spontaneous preterm birth <37 weeks of gestational age | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age | |
Secondary | Spontaneous preterm birth <34 weeks | Spontaneous preterm birth <34 weeks of gestational age | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age | |
Secondary | Spontaneous preterm birth <32 weeks | Spontaneous preterm birth <32 weeks of gestational age | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age | |
Secondary | Spontaneous preterm birth <28 weeks | Spontaneous preterm birth <28 weeks of gestational age | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age | |
Secondary | Prediction of preterm birth using cervical softening. | Development of a prediction model using cervical softening to predict the risk of preterm birth before 37, 34, 32 and 28 weeks. | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age | |
Secondary | Prediction of preterm birth using the combination of cervical softening and transvaginal cervical length measurement. | Development of a prediction model using the combination of cervical softening and transvaginal cervical length measurement to predict the risk of preterm birth before 37, 34, 32 and 28 weeks. | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age | |
Secondary | Prediction of preterm birth using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin. | Development of a prediction model using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin to predict the risk of preterm birth before 37, 34, 32 and 28 weeks. (only for symptomatic women) | From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age | |
Secondary | Prediction of latency time using cervical softening. | Development of a prediction model using cervical softening to predict the latency time (interval between inclusion and delivery). | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age | |
Secondary | Prediction of latency time using the combination of cervical softening and transvaginal cervical length measurement. | Development of a prediction model using the combination of cervical softening and transvaginal cervical length measurement to predict the latency time (interval between inclusion and delivery). | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age. | |
Secondary | Prediction of latency time using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin | Development of a prediction model using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin to predict the latency time. (interval between inclusion and delivery). (only for symptomatic women) | From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age. |
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