Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children's Long-Term Outcome

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03418311
• Date of registration: 23/01/2018
• Prospective Registration: Yes
• Primary sponsor: Bürgerhospital Frankfurt
• Public title: Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children's Long-Term Outcome Impetus
• 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
• Date of first enrolment: September 2020
• Target sample size: 672
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03418311
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Australia, Germany, Greece, Spain

Contacts

• Name: Ioannis Kyvernitakis, MD, PhD

• Name: Ioannis Kyvernitakis, MD, PhD
• Affiliation: Buergerhospital Frankfurt

Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Premature Birth

Preterm Birth

Intervention(s)

Device: Cervical Pessary-Group

Primary Outcome(s)

Children's survival without neurodevelopmental disability at the age of 3. [Time Frame: assesment of the newborns at age of 3 years (corrected age for prematurity)]

Secondary Outcome(s)

Fetal or neonatal death [Time Frame: at birth, within first 24 hours]

maternal death [Time Frame: enrollment till discharge from hospital, recorded for at least first 48 hrs after birth]

neonatal morbidity [Time Frame: birth till discharge from hospital, recorded for at least first 48 hrs after birth]

hospitalisation for threatened preterm labour before 31 +6 weeks of gestation [Time Frame: enrollment till birth, maximum 21 weeks]

rate of preterm birth [Time Frame: randomisation till birh, maximum 21 weeks]

infection / inflammation [Time Frame: enrollment till discharge from hospital, recorded for at least first 48 hrs after birth]

Need (days) for neonatal special care unit [Time Frame: birth till discharge from hospital, recorded for at least first 48 hrs after birth]

physical or psychological intolerance to cervical pessary [Time Frame: time from placement of cervical pessary at enrollment till removal of cervical pessary at WoG 37, maximum 21 weeks]

rate of significant maternal adverse events [Time Frame: enrollment till discharge from hospital, recorded for at least first 48 hrs after birth]

harm from intervention (neonate) [Time Frame: birth till discharge from hospital, recorded for at least first 48 hrs after birth]

birth weight of neonate [Time Frame: at birth]

premature rupture of membranes (ProM) before 31 +6 weeks of gestation [Time Frame: enrollment till birth, maximum 21 weeks]

time till birth [Time Frame: randomisation till birth, maximum 25 weeks]

Secondary ID(s)

BHFKIK2018I

Source(s) of Monetary Support

Please refer to primary and secondary sponsors