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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
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
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
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).
Trial website
https://clinicaltrials.gov/study/NCT03418311
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03418311