Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03418012
• Date of registration: 23/01/2018
• Prospective Registration: Yes
• Primary sponsor: Bürgerhospital Frankfurt
• Public title: Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB Prometheus
• 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
• Date of first enrolment: September 2020
• Target sample size: 310
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03418012
• 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: Asklepios Clinic Barmbek

Key inclusion & exclusion criteria

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

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



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

Other: Control-Group

Primary Outcome(s)

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

Secondary Outcome(s)

birth weight of the neonate [Time Frame: at birth]

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

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

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

Hospitalisation for threatened preterm labour before 31+6 weeks [Time Frame: randomization till birth, maximum 20 weeks]

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

rate of preterm birth [Time Frame: randomisation till birth, maximum 25 weeks]

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

time till birth [Time Frame: days from randomisation till birth, maximum 30 weeks]

physical or psychological intolerance to pessary [Time Frame: time from placement of cervical pessary at enrollment till removal of cervical pessary at WoG 37, maximum 25 weeks]

premature rupture of membranes (PRoM) before 31+6 weeks [Time Frame: randomization till birth, maximum 20 weeks]

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

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

Secondary ID(s)

BHFKIK2018P

Source(s) of Monetary Support

Please refer to primary and secondary sponsors