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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03418311
Registration number
NCT03418311
Ethics application status
Date submitted
23/01/2018
Date registered
1/02/2018
Date last updated
5/05/2020
Titles & IDs
Public title
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children's Long-Term Outcome
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Scientific title
Impact of Cervical Pessary Treatment for Prevention of Spontaneous Preterm Birth in Twin Pregnancies With Cervical Shortening on Children's Long-Term Survival Without Neurodevelopmental Disability: THE IMPETUS-TRIAL
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Secondary ID [1]
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BHFKIK2018I
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Universal Trial Number (UTN)
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Trial acronym
Impetus
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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-Group
No Intervention: 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.
Experimental: Cervical Pessary-Group - placement of the cervical pessary (non-invasive) at enrollment; removal of the cervical pessary (non-invasive) in a regular preventive examination at WoG 37.
Treatment: Devices: 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 week of gestation 37+0. Except for placement/removal of cervical pessary the pregnant women will receive the usual care.
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Intervention code [1]
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Treatment: Devices
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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.
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Assessment method [1]
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Recording of the mortality rate of the newborns; neurodevelopmental disability will be assessed by the Ages & Stages Questionnaire and by medical examination of the newborn at the age of 3 years
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Timepoint [1]
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assesment of the newborns 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 birh, maximum 21 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 to birth
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Timepoint [2]
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randomisation till birth, maximum 25 weeks
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Secondary outcome [3]
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birth weight of neonate
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Assessment method [3]
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birth weight in gram recorded at the 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 hrs
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Timepoint [4]
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at birth, within first 24 hours
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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 intervention 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 (neonate)
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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 / 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 cervical pessary
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Assessment method [11]
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rate of maternal physical or psychological intolerance to cervical 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 21 weeks
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Secondary outcome [12]
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hospitalisation for threatened preterm labour before 31 +6 weeks of gestation
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Assessment method [12]
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recording of days of hospitalisation for threatened preterm labour before 31 +6 weeks of gestation and recording tocolytic treatment (type/ days/dose)
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Timepoint [12]
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enrollment till birth, maximum 21 weeks
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Secondary outcome [13]
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premature rupture of membranes (ProM) before 31 +6 weeks of gestation
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Assessment method [13]
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rate of women with premature rupture of membranes (ProM) before 31 +6 weeks of gestation
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Timepoint [13]
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enrollment till birth, maximum 21 weeks
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Eligibility
Key inclusion criteria
- women with a diamniote twin pregnancy at 16-28 weeks of gestation with a shortened
cervix = 25 percentile
- women = 18 years and capable of giving consent
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Minimum age
18
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Maximum age
45
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- monoamniote pregnancy
- major fetal abnormalities
- suspected twin-to-twin transfusion syndrome
- intrauterine death of one twin
- uterine malformation
- placenta previa totalis
- Cerclage prior to randomization
- active vaginal bleeding and/or spontaneous rupture of membranes and/or painful regular
uterine contractions
- silicone allergy
- current participation in other RCT to avoid treatment conflicts
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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
Not Applicable
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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
1/12/2024
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Actual
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Sample size
Target
672
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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
Preterm birth (PTB) complicates 13% of all pregnancies worldwide and is the most important
cause of neonatal morbidity and mortality. Women with a twin pregnancy are at increased risk
of preterm delivery. In the Netherlands, approximately 50% of women with a multiple pregnancy
deliver before 37 weeks of gestation (WoG), of whom 9% deliver before 32 weeks. Evidence
based treatment guidelines concerning prevention of PTB are not available in Europe.
Expectant management is usual care 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. The studies done on this topic included women at different stages of
the second trimester so the question of the onset of cervix shortening and its impact on PTB
is not answered yet. The critical period for a maximum impact of the pessary treatment on PTB
is still to be verified. Up to now only the ProTwinTrial addressed the long-term outcome of
the newborns, so here data and evidence is clearly missing. The investigators want to assess
the impact of a cervical pessary treatment in twin pregnancies with cervical shortening on
children's survival without neurodevelopmental disability at the age of 3 years at 3
different stages of the second trimester (16-20 (early) vs. 20-24 (middle) vs. 24-28 (late)
weeks of gestation).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03418311
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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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Buergerhospital Frankfurt
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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 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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03418311
Download to PDF