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

NCT03418311 | Unknown DMC

• 1 other identifier: BHFKIK2018I
• Study Type: interventional
• Target: 672
• Locations: 4 countries
• Sites: 10

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).

Conditions

Preterm Birth; Premature Birth

Keywords

Twin pregnancy; Cervical Pessary; short cervix; Prevention

Outcome Measures

Primary Outcomes (1)

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

  Recording of the mortality rate of the newborns; neurodevelopmental disability will be assessed by the Ages \& Stages Questionnaire and by medical examination of the newborn at the age of 3 years

  assesment of the newborns at age of 3 years (corrected age for prematurity)

Secondary Outcomes (13)

• rate of preterm birth

  randomisation till birh, maximum 21 weeks

• time till birth

  randomisation till birth, maximum 25 weeks

• birth weight of neonate

  at birth

• Fetal or neonatal death

  at birth, within first 24 hours

• Need (days) for neonatal special care unit

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

Study Arms (2)

Control-Group

NO INTERVENTION

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.

Cervical Pessary-Group

EXPERIMENTAL

placement of the cervical pessary (non-invasive) at enrollment; removal of the cervical pessary (non-invasive) in a regular preventive examination at WoG 37.

Device: Cervical Pessary-Group

Interventions

Cervical Pessary-Group DEVICE

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.

Also known as: Arabin Cervical Pessary

Cervical Pessary-Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women being pregnant with a twin gestation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bürgerhospital Frankfurt: lead

Study Sites (10)

University of Adelaide

Adelaide, Australia

Location

Charite-Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Bürgerhospital Frankfurt/M.

Frankfurt, 60318, 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

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Ioannis Kyvernitakis, MD, PhD

  Buergerhospital Frankfurt

  STUDY DIRECTOR

Central Study Contacts

Ioannis Kyvernitakis, MD, PhD

CONTACT

+49 49 1768248; janniskyvernitakis@gmail.com

Marita Wasenitz, MA Biology

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

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

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DE (6); GR (2); AU (1)