Randomized Study of Pessary Versus Standard Management in Women With Increased Chance of Premature Birth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by King's College Hospital NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT00735137
First received: August 13, 2008
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

The aim of the study is to determine the effect of cerclage pessary on the incidence of spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic women with singleton pregnancies found at routine mid-trimester screening to have a cervix of <25 mm in length and in twin pregnancies.


Condition Intervention Phase
Preterm Birth
Device: Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Study of Pessary vs Standard Management in Women With Increased Chance of Premature Birth

Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • The primary outcome measure will be spontaneous delivery from randomization to 33 weeks and 6 days (237 days) of gestation. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Low birth weight; Fetal or neonatal death; Major adverse outcomes (IVH, RDS, retinopathy of prematurity or necrotizing enterocolitis); Need for neonatal special care (ventilation, phototherapy, treatment for sepsis, blood transfusion) [ Time Frame: Within the first year ] [ Designated as safety issue: No ]

Estimated Enrollment: 2780
Study Start Date: August 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Expectant management in twin pregnancy
Experimental: B
Vaginal pessary treatment in twin pregnancy
Device: Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003)
Inserted from randomization till 36-37 weeks of gestation
Other Name: Vaginal pessary, CE0482, MED/CERT ISO 9003 / EN 46003
No Intervention: C
Expectant management in singleton pregnancy with short cervix
Experimental: D
Vaginal pessary treatment in singleton pregnancy with short cervix
Device: Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003)
Inserted from randomization till 36-37 weeks of gestation
Other Name: Vaginal pessary, CE0482, MED/CERT ISO 9003 / EN 46003

Detailed Description:

Prematurity is responsible for more than half of all neonatal deaths and whilst advances in neonatal care have dramatically improved survival of extremely premature infants, there remains a significant risk of handicap and disability in survivors and an associated social and economic burden.

In singleton pregnancies the rate of spontaneous premature birth before 34 weeks is about 1% and the risk of spontaneous early delivery is inversely related to cervical length. The group with cervix of 1-15 mm accounted for 28% of all spontaneous deliveries before 34 weeks and those with cervix of 16-25 mm accounted for 21%. The rate of spontaneous premature birth before 34 weeks is about 13% in twin pregnancies.

Potential methods for the prevention of preterm delivery include bed rest, cervical cerclage and prophylactic administration of progesterone. The prophylactic administration of progesterone beginning in mid-gestation to women who previously had a premature birth and in those with a short cervix has been shown to reduce the rate of spontaneous preterm birth before 34 weeks. On the other hand, randomized studies reported that, in twin pregnancies, bed rest was associated with a significant increase, rather than decrease, in the rate of early preterm delivery.

There is some evidence that the rate of premature birth can be dramatically reduced by the insertion of a vaginal pessary (cerclage pessary, CE0482, MED/CERT ISO 9003 / EN 46003).

This will be a multicenter trial in the UK and other countries. During routine ultrasound scan at 20-24 weeks of gestation for examination of fetal anatomy and growth, all women with twin pregnancy or with singleton pregnancy found to have a cervix of <25 mm in length and where the fetuses are found to be alive with no major abnormalities, severe twin to twin transfusion syndrome or severe fetal growth restriction in one of the fetuses (in the case of twin pregnancy), will be invited to participate in a randomized trial of standard management vs vaginal insertion of a cerclage pessary. For singleton pregnancy, in both arms the patients with cervical length <15 mm will be given prophylactic progesterone (200 mg vaginal capsule per night up to 34 weeks). Randomization and insertion of the pessary (in those allocated to this group) will be carried out within 5 days after the 20-24 weeks scan.

The pessary will be removed by a simple vaginal examination at 37 weeks or earlier before medically indicated preterm induction of labor or elective cesarean section. The pessary will also be removed in women in preterm labor not responding to tocolytic therapy. In monochorionic twins some obstetricians advise that delivery is carried out at around 36 weeks.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women with singleton pregnancies and with a cervical length of 25 mm or less
  2. Women with twin pregnancies

Exclusion Criteria:

  1. Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, severe twin to twin transfusion syndrome or severe fetal growth restriction in one of the fetuses (in the case of twin pregnancy) diagnosed before randomization.
  2. Painful regular uterine contractions, history of ruptured membranes, or prophylactic cerclage before randomization.
  3. Patients who are unconscious, severely ill, mentally handicapped or under the age of 16 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735137

Contacts
Contact: Kypros Nicolaides, Professor +442032999000 ext 8256 kypros@fetalmedicine.com

Locations
Austria
Medical University of Vienna-department of Obstetrics and Gynaecology Recruiting
Vienna, Austria, 1090
Contact: Katharina Klein, Consultant       katharina.klein@meduniwien.ac.at   
Principal Investigator: Christoff Worda, Consultant         
Sub-Investigator: Katharina Klein, Consultant         
Sub-Investigator: Mariella Mailath-Pokorny, Consultant         
Sub-Investigator: Armin Witt, Consultant         
Brazil
Universidade Federal Fluminense - Hospital Universitário Antônio Pedro Not yet recruiting
Niteroi, Rio de Janeiro, Brazil, 24033-900
Contact: Luciana de Barros Duarte, Professor       lucianadebarros@terra.com.br   
Principal Investigator: Luciana de Barros Duarte, Professor         
University of Campinas Not yet recruiting
Sao Paulo, Brazil
Contact: Cleisson Fabio Andrioli Peralta, Consultant       cfaperalta@hotmail.com   
Principal Investigator: Cleisson Fabio Andrioli Peralta, Consultant         
Chile
Hospital Clinico Universidad de Chile Recruiting
Santiago, Chile
Contact: Mauro Parra, Consultant       mcparra@redclinicauchile.cl   
Principal Investigator: Mauro Parra, Consultant         
Colombia
Hospital San Jose Not yet recruiting
Bogota, Colombia
Contact: Jose Luis Rojas, Consultant         
Principal Investigator: Jose Luis Rojas, Consultant         
Sub-Investigator: Edgar Acuna, Consultant         
Hospital Universitario San Vicente de Paúl Recruiting
Medellin, Colombia
Contact: Juan Guillermo Londono, Consultant         
Principal Investigator: Juan Guillermo Londono, Consultant         
Sub-Investigator: Diana Jaramillo, Consultant         
Germany
Virchow Clinic Charite Recruiting
Berlin, Germany
Contact: Ilka Fuchs, Consultant       ilka.fuchs@charite.de   
Principal Investigator: Ilka Fuchs, Consultant         
Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: TK Lau, Consultant       tzekinlau@cuhk.edu.hk   
Principal Investigator: TK Lau, Consultant         
India
Fernandez Hospital, Bogulkunta, Not yet recruiting
Bogulkunta, India, 500001
Contact: Suseela Vavilala, Consultant       geetkolar@gmail.com   
Principal Investigator: Suseela Vavilala, Consultant         
Italy
Ospedale Valduce Recruiting
Como, Lombardy, Italy, 22100
Contact: Roberto Conturso, Consultant       conturso2@libero.it   
Principal Investigator: Roberto Conturso, Consultant         
Portugal
Maternidade Dr. Alfredo da Costa Not yet recruiting
Lisbon, Portugal
Contact: Teresinha Simoes, Consultant       teresinhasimoes@netcabo.pt   
Principal Investigator: Teresinha Simoes, Consultant         
Hospital San Teotonio Recruiting
Viseu, Portugal
Contact: Susana Luisa Pereira, Consultant       susana.luisa.pereira@iol.pt   
Principal Investigator: Susana Louisa Pereira, Consultant         
Sub-Investigator: James Anderson, R.Fellow         
Slovenia
University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Natasa Tul, Consultant       natasa.tul@guest.arnes.si   
Principal Investigator: Natasa Tul, Consultant         
Sub-Investigator: Natasa Vrhkar, Consultant         
Sub-Investigator: Marusa Strgulc, Consultant         
Spain
Hospital Universitario Materno Infantil de Canarias Recruiting
Las Palmas de Gran Canaria, Islas Canarias, Spain, 35016
Contact: Walter Plasencia Acevedo, Consultant       walterplasencia@mac.com   
Principal Investigator: Walter Plasencia Acevedo, Consultant         
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Francisca S Molina Garcia, Consultant       fsoniamolina@gmail.com   
Principal Investigator: Francisca S Molina Garcia, Consultant         
Sub-Investigator: Rodrigo Terra, R.Fellow         
Virgen de La Arrixaca Recruiting
Murcia, Spain
Contact: Catalina De Paco, Consultant       katydepaco@hotmail.com   
Principal Investigator: Catalina De Paco, Consultant         
United Kingdom
Heatherwood and Wexham Park Hospitals, Wexham Park Hospital Recruiting
Slough, Berkshire, United Kingdom, SL2 4HL
Contact: Shaku Kalla, Consultant       shaku.kalla@hwph-thames.nhs.uk   
Principal Investigator: Shaku Kall, Consultant         
Sub-Investigator: Esperanza Gonzalez, R.Fellow         
Sub-Investigator: Gemma Picciarelli, R.Fellow         
Barking, Havering and Redbridge Hospitals NHS Trust Recruiting
Romford, Essex, United Kingdom, RM7 0AG
Contact: Chineze Otigbah, MRCOG    +441708435566    chineze.otigbah@bhrhospitals.nhs.uk   
Principal Investigator: Chineze Otigbah, MRCOG         
Southend Hospital NHS Trust Recruiting
Essex, United Kingdom, SS0 0RY
Contact: Narayanaswamy V Raman, MRCOG    +441702435555    narayanaswamyraman@southend.nhs.uk   
Principal Investigator: Narayanaswamy V Raman, MRCOG         
Sub-Investigator: Ebru Celik, R.Fellow         
Sub-Investigator: Mara Mitrea, R.Fellow         
Sub-Investigator: Evdoxia Skyfta, R.Fellow         
Sub-Investigator: Jesus Rodriguez, R.Fellow         
The Medway Maritime Hospital NHS Trust Recruiting
Kent, United Kingdom, ME7 5NY
Contact: Nikos Kametas, MRCOG    +441634830000 ext 5115    n.kametas@btinternet.com   
Principal Investigator: Nikos Kametas, MRCOG         
Sub-Investigator: Ebru Celik, R.Fellow         
Sub-Investigator: Esperanza Gonzalez, R.Fellow         
Sub-Investigator: Gemma Picciarelli, R.Fellow         
Queen Elizabeth Hospital NHS Trust Recruiting
London, United Kingdom, SE18 4QH
Contact: Vadivu Palanappian, MRCOG    +442088366000    vadivu.palaniappan@nhs.net   
Principal Investigator: Vadivu Palanappian, MRCOG         
Sub-Investigator: Ebru Celik, R.Fellow         
Sub-Investigator: Antonio Leal, R.Fellow         
Sub-Investigator: Evdoxia Skyfta, R.Fellow         
Sub-Investigator: Jesus Rodriguez, R.Fellow         
University College London Hospitals NHS Foundation Trust Not yet recruiting
London, United Kingdom, NW1 2BU
Contact: Pranav Pandya, MRCOG    +448451555000 ext 8727    pranav.pandya@uclh.nhs.uk   
Principal Investigator: Pranav Pandya, MRCOG         
King's College Hospital NHS Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Kypros Nicolaides, Professor    +442032999000 ext 8456    kypros@fetalmedicine.com   
Principal Investigator: Kypros Nicolaides, Professor         
Sub-Investigator: Leona Poon, R.Fellow         
Sub-Investigator: Catalina Valencia, R.Fellow         
Sub-Investigator: Ebru Celik, R.Fellow         
Sub-Investigator: Antonio Leal, R.Fellow         
Sub-Investigator: James M Anderson, R.Fellow         
Sub-Investigator: Esperanza Gonzalez, R.Fellow         
Sub-Investigator: Gemma Picciarelli, R.Fellow         
Sub-Investigator: Evdoxia Skyfta, R.Fellow         
Sub-Investigator: Jesus Rodriguez, R.Fellow         
The Lewisham Hospital NHS Trust Recruiting
London, United Kingdom, SE13 6LH
Contact: Ashis Sau, MRCOG    +442083333182    Ashis.Sau@uhl.nhs.uk   
Principal Investigator: Ashis Sau, MRCOG         
Sub-Investigator: Ebru Celik, R.Fellow         
Sub-Investigator: Antonio Leal, R.Fellow         
Sub-Investigator: Rodrigo Terra, R.Fellow         
Sub-Investigator: Catalina Valencia, R.Fellow         
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Study Director: Kypros H Nicolaides, Professor Consultant,Director of the Department of Fetal Medicine
  More Information

No publications provided

Responsible Party: Kypros Nicolaides, King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00735137     History of Changes
Other Study ID Numbers: 07/HW/10, ISRCTN01096902
Study First Received: August 13, 2008
Last Updated: November 2, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by King's College Hospital NHS Trust:
Twins
Short cervix
Preterm birth
Vaginal pessary

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 22, 2014