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

NCT03418012 | Unknown DMC

• 1 other identifier: BHFKIK2018P
• Study Type: interventional
• Target: 310
• Locations: 4 countries
• Sites: 9

Brief Summary

Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well. The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity \< 34 week of gestation (WoG). The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.

Conditions

Preterm Birth; Premature Birth

Keywords

Cervical Pessary; Short Cervix; Recurrent Preterm Birth; history of cervical surgery; history of conisation

Outcome Measures

Primary Outcomes (1)

• Children's survival without neurodevelopmental disability at the age of 3 years

  * mortality rate will be recorded * neurodevelopmental disability will be assessed by the Ages \& Stages questionnaire and by medical examination at 3 years of age (corrected age for prematurity)

  assessment of the newborn at age of 3 years (corrected age for prematurity)

Secondary Outcomes (13)

• rate of preterm birth

  randomisation till birth, maximum 25 weeks

• time till birth

  days from randomisation till birth, maximum 30 weeks

• birth weight of the neonate

  at birth

• Fetal or neonatal death

  at birth, first 24 hours after birth

• Need (days) for neonatal special care unit

  birth till discharge from hospital, recorded for at least first 48 hrs after birth

Study Arms (2)

Cervical Pessary-Group

EXPERIMENTAL

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 WoG 37

Device: cervical pessary

Control-Group

OTHER

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

Other: Control-Group

Interventions

cervical pessary DEVICE

Intervention: Device: Cervical pessary: After Having excluded a vaginal infection insertion of the cervical pessary (silicone ring) directly after enrollment. After insertion verification of correct fit of the cervical pessary by transvaginal ultrasound. Removal of the pessary at 37+0 weeks of gestation, or before if any unexpected event occurs. Except for the insertion of the pessary the obstetrical management during the remainder of the pregnancy will be usual management.

Also known as: Arabin Cervical Pessary

Cervical Pessary-Group

Control-Group OTHER

Intervention: Other: expectant management: expectant management is usual care; interventions only in terms of a tertiary prevention of PTB according to guidelines for premature rupture of membranes, premature labour or other pregnancy complications

Control-Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: only pregnant woman (singleton gestation)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• +0 - 16+0 weeks of gestation at time of randomization
• only women with minimum age of 18 and capable of giving consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bürgerhospital Frankfurt: lead

Study Sites (9)

University of Adelaide

Adelaide, Australia

Location

Charité - Universitätsmedizin

Berlin, 10117, Germany

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Asklepios Kliniken Krankenhaus Barmbeck

Hamburg, 22087, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66424, Germany

Location

University Hospital of Athens

Athens, Greece

Location

Medical School of Aristotle-University of Thessaloniki

Thessaloniki, Greece

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Related Publications (1)

• Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508.

  PMID: 36453699 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ioannis Kyvernitakis, MD, PhD

  Asklepios Clinic Barmbek

  STUDY DIRECTOR

Central Study Contacts

Ioannis Kyvernitakis, MD, PhD

CONTACT

+49 1768248; janniskyvernitakis@gmail.com

Marita Wasenitz, MA

CONTACT

+49 69 1500; m.wasenitz@buergerhospital-ffm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: due to the nature of the intervention (placement of a cervical pessary) a masking is not possible
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: parallel groups: * Controll group with management as usual * Pessary group with insertion of cervical pessary at 12+0-16+0 weeks of gestation

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 31, 2018
• Study Start: September 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2); AU (1); ES (1); DE (5)