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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03418311




Registration number
NCT03418311
Ethics application status
Date submitted
23/01/2018
Date registered
1/02/2018

Titles & IDs
Public title
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children's Long-Term Outcome
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
Secondary ID [1] 0 0
BHFKIK2018I
Universal Trial Number (UTN)
Trial acronym
Impetus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Birth 0 0
Premature Birth 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Children's survival without neurodevelopmental disability at the age of 3.
Timepoint [1] 0 0
assesment of the newborns at age of 3 years (corrected age for prematurity)
Secondary outcome [1] 0 0
rate of preterm birth
Timepoint [1] 0 0
randomisation till birh, maximum 21 weeks
Secondary outcome [2] 0 0
time till birth
Timepoint [2] 0 0
randomisation till birth, maximum 25 weeks
Secondary outcome [3] 0 0
birth weight of neonate
Timepoint [3] 0 0
at birth
Secondary outcome [4] 0 0
Fetal or neonatal death
Timepoint [4] 0 0
at birth, within first 24 hours
Secondary outcome [5] 0 0
Need (days) for neonatal special care unit
Timepoint [5] 0 0
birth till discharge from hospital, recorded for at least first 48 hrs after birth
Secondary outcome [6] 0 0
neonatal morbidity
Timepoint [6] 0 0
birth till discharge from hospital, recorded for at least first 48 hrs after birth
Secondary outcome [7] 0 0
harm from intervention (neonate)
Timepoint [7] 0 0
birth till discharge from hospital, recorded for at least first 48 hrs after birth
Secondary outcome [8] 0 0
maternal death
Timepoint [8] 0 0
enrollment till discharge from hospital, recorded for at least first 48 hrs after birth
Secondary outcome [9] 0 0
rate of significant maternal adverse events
Timepoint [9] 0 0
enrollment till discharge from hospital, recorded for at least first 48 hrs after birth
Secondary outcome [10] 0 0
infection / inflammation
Timepoint [10] 0 0
enrollment till discharge from hospital, recorded for at least first 48 hrs after birth
Secondary outcome [11] 0 0
physical or psychological intolerance to cervical pessary
Timepoint [11] 0 0
time from placement of cervical pessary at enrollment till removal of cervical pessary at WoG 37, maximum 21 weeks
Secondary outcome [12] 0 0
hospitalisation for threatened preterm labour before 31 +6 weeks of gestation
Timepoint [12] 0 0
enrollment till birth, maximum 21 weeks
Secondary outcome [13] 0 0
premature rupture of membranes (ProM) before 31 +6 weeks of gestation
Timepoint [13] 0 0
enrollment till birth, maximum 21 weeks

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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
672
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
Germany
State/province [2] 0 0
Frankfurt
Country [3] 0 0
Germany
State/province [3] 0 0
Hamburg
Country [4] 0 0
Germany
State/province [4] 0 0
Homburg
Country [5] 0 0
Greece
State/province [5] 0 0
Athen
Country [6] 0 0
Greece
State/province [6] 0 0
Thessaloníki
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Other
Name
Bürgerhospital Frankfurt
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ioannis Kyvernitakis, MD, PhD
Address 0 0
Buergerhospital Frankfurt
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ioannis Kyvernitakis, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+49 49 1768248
Fax 0 0
Email 0 0
janniskyvernitakis@gmail.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03418311