Cervical Incompetence in Pregnancy as Antepartum Condition, Cervical Incompetence, With Delivery, Diagnosis, Premature Birth, Premature Labor, Preterm Birth, Threatened Preterm Labor
Conditions
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.
Detailed description
Preterm birth (PTB) is amongst the leading causes of perinatal and childhood morbidity and mortality. Therefore, accurate identification of pregnant women at high risk of PTB is important. Identifying these women, enables obstetric healthcare professionals to apply interventions to postpone delivery and/or to prevent PTB to improve perinatal and childhood outcomes. Currently, transvaginal cervical length measurement is used to screen asymptomatic pregnant women with a history of PTB to identify women requiring a cerclage. In symptomatic women, presenting with threatened (PTB), cervical length in combination with the fetal fibronectin(fFN) test is used to identify women at high risk to deliver within 7 days of presentation. 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. Since cervical softening is a precursor of cervical shortening, effacement and dilatation, cervical softening is a promising new marker that is based on tissue elasticity. It can be measured with the CE-marked Pregnolia® System for accurate characterization of cervical softening status. It provides a value for tissue elasticity on a continuous scale. A previous study has shown that softening of the cervix can be detected before shortening of the cervix. The Pregnolia® System may allow to detect women at risk for PTB earlier compared to traditional transvaginal ultrasound that measures shortening of the cervix, and therefore may prove useful for a more accurate risk assessment of PTB. This current study is a single centre cohort study, where Two cohorts of women will be investigated. 1) Asymptomatic pregnant women with a history of spontaneous PTB before 34 weeks of gestation (Cohort A-STIPP). 2) Symptomatic women presenting with threatened PTB between 24 and 34 weeks (Cohort S-STIPP). Objective: The aim of this study is to evaluate the predictive capacity of cervical softening and risk of PTB.
Interventions
DIAGNOSTIC_TESTMeasurement of cervical stiffness by Pregnolia Device
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.
Sponsors
Pregnolia AG
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous Preterm Birth < 34 weeks | 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. | Spontaneous preterm birth before 34 weeks of gestation in the asymptomatic cohort |
| Delivery within seven days after inclusion | From inclusion until 7 days later | Delivery within seven days after inclusion in the symptomatic cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Spontaneous preterm birth \<28 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 | Development of a prediction model using cervical softening to predict the risk of preterm birth before 37, 34, 32 and 28 weeks. |
| Prediction of preterm birth using the combination of cervical softening and transvaginal cervical length measurement. | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age | 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. |
| Prediction of preterm birth using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin. | From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age | 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) |
| Prediction of latency time 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 | Development of a prediction model using cervical softening to predict the latency time (interval between inclusion and delivery). |
| Prediction of latency time using the combination of cervical softening and transvaginal cervical length measurement. | From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age. | 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). |
| Prediction of latency time using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin | From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age. | 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) |
| 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 \<37 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 \<34 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 \<32 weeks of gestational age |
Other
| Measure | Time frame | Description |
|---|---|---|
| Preterm Prelabour Rupture of membranes at moment of measurement | Within 1 hour after measurement | Preterm Prelabour Rupture of membranes at moment of measurement |
| Irritation and sensitization of mucosal tissue | Within 1 hour after measurement | Irritation and sensitization of mucosal tissue as noticed by the researcher performing the measurement |
| Superficial lacerations or minor tissue abrasions | Within 1 hour after measurement | Superficial lacerations or minor tissue abrasions |
| 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 | Pain during Pregnolia measured on a visual analogue scale (VAS) from no painto worst possible pain |
| Infections within seven days of measurement | From inclusion up to 1 week | Infections within seven days of measurement (urinary tract infections, vaginal infections, intra-uterine infections) |
| 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 | Vaginal or Cervical blood loss, noticed directly (= within 30 minutes) after measurement |
Countries
Netherlands
Contacts
Primary ContactSofie Breuking, drs
Backup ContactFrederik Hermans, PhD, MSc
Outcome results
None listed