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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03418012
Registration number
NCT03418012
Ethics application status
Date submitted
23/01/2018
Date registered
31/01/2018
Titles & IDs
Public title
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
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Scientific title
Effect of History-indicated Early Treatment With Cervical Pessary Versus Expectant Management Treatment With Rescue Cerclage in Cases With Cervical Shortening in Singleton Pregnancies at High-risk for sPTB on Children's Long-term Outcome
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Secondary ID [1]
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BHFKIK2018P
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Universal Trial Number (UTN)
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Trial acronym
Prometheus
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Preterm Birth
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Premature Birth
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Condition category
Condition code
Reproductive Health and Childbirth
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Complications of newborn
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - cervical pessary
Other interventions - Control-Group
Experimental: Cervical Pessary-Group - Cervical Pessary Group: placement of the cervical pessary (non-invasive) at enrolment including a transvaginal ultrasound to verify its correct fit. Removal of the cervical pessary (non-invasive) in a regular preventive examination at WoG 37
Other: Control-Group - Control-Group women receive management as usual; i.e. expectant management with interventions only in terms of a tertiary prevention of PTB according to guidelines for premature rupture of membranes, premature labour or other pregnancy complications
Treatment: Devices: cervical pessary
Intervention: Device: Cervical pessary: After Having excluded a vaginal infection insertion of the cervical pessary (silicone ring) directly after enrollment. After insertion verification of correct fit of the cervical pessary by transvaginal ultrasound. Removal of the pessary at 37+0 weeks of gestation, or before if any unexpected event occurs. Except for the insertion of the pessary the obstetrical management during the remainder of the pregnancy will be usual management.
Other interventions: Control-Group
Intervention: Other: expectant management: expectant management is usual care; interventions only in terms of a tertiary prevention of PTB according to guidelines for premature rupture of membranes, premature labour or other pregnancy complications
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Children's survival without neurodevelopmental disability at the age of 3 years
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Assessment method [1]
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* mortality rate will be recorded
* neurodevelopmental disability will be assessed by the Ages \& Stages questionnaire and by medical examination at 3 years of age (corrected age for prematurity)
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Timepoint [1]
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assessment of the newborn at age of 3 years (corrected age for prematurity)
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Secondary outcome [1]
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rate of preterm birth
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Assessment method [1]
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rate of delivery before weeks of gestation: 36+6 / 33+6 / 31+6 / 29+6 / 27+6
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Timepoint [1]
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randomisation till birth, maximum 25 weeks
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Secondary outcome [2]
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time till birth
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Assessment method [2]
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time span from enrollment till birth
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Timepoint [2]
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days from randomisation till birth, maximum 30 weeks
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Secondary outcome [3]
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birth weight of the neonate
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Assessment method [3]
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birth weight of the neonate in grams recorded at hospital
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Timepoint [3]
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at birth
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Secondary outcome [4]
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Fetal or neonatal death
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Assessment method [4]
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death of the neonate before birth /within first 24 hours
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Timepoint [4]
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at birth, first 24 hours after birth
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Secondary outcome [5]
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Need (days) for neonatal special care unit
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Assessment method [5]
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Number of days the neonate is transferred to ICU for medical interventions other than supervision
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Timepoint [5]
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birth till discharge from hospital, recorded for at least first 48 hrs after birth
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Secondary outcome [6]
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neonatal morbidity
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Assessment method [6]
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rate of major adverse neonatal outcomes: Intraventricular Haemorrhage III-IV, Retinopathy of prematurity, Respiratory Distress Syndrome II-IV, Need for ventilation \> 72 h, Necrotising enterocolitis, Proven or suspected sepsis (antibiotics \>5 days)
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Timepoint [6]
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birth till discharge from hospital, recorded for at least first 48 hrs after birth
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Secondary outcome [7]
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harm from intervention
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Assessment method [7]
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recording any harm of the neonate deriving from the cervical pessary
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Timepoint [7]
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birth till discharge from hospital, recorded for at least first 48 hrs after birth
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Secondary outcome [8]
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maternal death
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Assessment method [8]
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rate of maternal death due to pregnancy/birth
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Timepoint [8]
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enrollment till discharge from hospital, recorded for at least first 48 hrs after birth
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Secondary outcome [9]
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rate of significant maternal adverse events
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Assessment method [9]
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rate of : heavy bleeding, cervical tear due to pessary placement, uterine rupture
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Timepoint [9]
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enrollment till discharge from hospital, recorded for at least first 48 hrs after birth
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Secondary outcome [10]
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infection/inflammation
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Assessment method [10]
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rate of maternal infection and/or inflammation during pregnancy / birth
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Timepoint [10]
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enrollment till discharge from hospital, recorded for at least first 48 hrs after birth
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Secondary outcome [11]
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physical or psychological intolerance to pessary
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Assessment method [11]
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rate of maternal physical or psychological intolerance to pessary during pregnancy
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Timepoint [11]
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time from placement of cervical pessary at enrollment till removal of cervical pessary at WoG 37, maximum 25 weeks
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Secondary outcome [12]
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Hospitalisation for threatened preterm labour before 31+6 weeks
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Assessment method [12]
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Hospitalisation for threatened preterm labour before 31+6 weeks: recording of days of hospitalisation and tocolytic treatment: type / days / dose
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Timepoint [12]
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randomization till birth, maximum 20 weeks
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Secondary outcome [13]
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premature rupture of membranes (PRoM) before 31+6 weeks
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Assessment method [13]
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rate of women with premature rupture of membranes (PRoM) before 31+6 weeks
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Timepoint [13]
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randomization till birth, maximum 20 weeks
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Eligibility
Key inclusion criteria
* Women with a singleton pregnancy and a history of at least one previous preterm delivery before 34+0 weeks and/or a history of at least one previous cervical surgery
* 12+0 - 16+0 weeks of gestation at time of randomization
* only women with minimum age of 18 and capable of giving consent
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* major fetal abnormalities
* uterine malformation, placenta previa totalis
* Cerclage prior to randomization
* At randomisation: active vaginal bleeding and/or spontaneous rupture of membranes and/or painful regular uterine contractions
* silicone allergy
* current participation in other RCT
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/09/2020
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2024
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Actual
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Sample size
Target
310
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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University of Adelaide - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Berlin
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Country [2]
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Germany
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State/province [2]
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Frankfurt
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Country [3]
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Germany
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State/province [3]
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Hamburg
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Country [4]
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Germany
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State/province [4]
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Homburg
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Country [5]
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Greece
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State/province [5]
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Athen
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Country [6]
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Greece
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State/province [6]
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Thessaloníki
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Country [7]
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Spain
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State/province [7]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bürgerhospital Frankfurt
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well. The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity \< 34 week of gestation (WoG). The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.
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Trial website
https://clinicaltrials.gov/study/NCT03418012
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ioannis Kyvernitakis, MD, PhD
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Address
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Asklepios Clinic Barmbek
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ioannis Kyvernitakis, MD, PhD
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Address
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Country
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Phone
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+49 1768248
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/12/NCT03418012/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/12/NCT03418012/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03418012