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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Child, Adult)
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

Locations
Austria
Medical University of Vienna-department of Obstetrics and Gynaecology
Vienna, Austria, 1090
Brazil
Universidade Federal Fluminense - Hospital Universitário Antônio Pedro
Niteroi, Rio de Janeiro, Brazil, 24033-900
University of Campinas
Sao Paulo, Brazil
Chile
Hospital Clinico Universidad de Chile
Santiago, Chile
Colombia
Hospital San Jose
Bogota, Colombia
Hospital Universitario San Vicente de Paúl
Medellin, Colombia
Germany
Virchow Clinic Charite
Berlin, Germany
Hong Kong
Chinese University of Hong Kong
Hong Kong, Hong Kong
India
Fernandez Hospital, Bogulkunta,
Bogulkunta, India, 500001
Italy
Ospedale Valduce
Como, Lombardy, Italy, 22100
Portugal
Maternidade Dr. Alfredo da Costa
Lisbon, Portugal
Hospital San Teotonio
Viseu, Portugal
Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia
Spain
Hospital Universitario Materno Infantil de Canarias
Las Palmas de Gran Canaria, Islas Canarias, Spain, 35016
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Virgen de La Arrixaca
Murcia, Spain
United Kingdom
Heatherwood and Wexham Park Hospitals, Wexham Park Hospital
Slough, Berkshire, United Kingdom, SL2 4HL
Barking, Havering and Redbridge Hospitals NHS Trust
Romford, Essex, United Kingdom, RM7 0AG
Southend Hospital NHS Trust
Essex, United Kingdom, SS0 0RY
The Medway Maritime Hospital NHS Trust
Kent, United Kingdom, ME7 5NY
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
The Lewisham Hospital NHS Trust
London, United Kingdom, SE13 6LH
Queen Elizabeth Hospital NHS Trust
London, United Kingdom, SE18 4QH
King's College Hospital NHS Trust
London, United Kingdom, SE5 9RS
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

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 December 02, 2016