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

NCT00735137 | Completed Phase 3 DMC

• 2 other identifiers: 07/HW/10ISRCTN01096902
• Study Type: interventional
• Target: 2,109
• Locations: 12 countries
• Sites: 24

Brief Summary

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.

Conditions

Preterm Birth

Keywords

Twins; Short cervix; Preterm birth; Vaginal pessary

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be spontaneous delivery from randomization to 33 weeks and 6 days (237 days) of gestation.

  10 weeks

Secondary Outcomes (1)

• 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)

  Within the first year

Study Arms (4)

A

NO INTERVENTION

Expectant management in twin pregnancy

B

EXPERIMENTAL

Vaginal pessary treatment in twin pregnancy

Device: Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003)

C

NO INTERVENTION

Expectant management in singleton pregnancy with short cervix; Women with cervix \<15 mm will be commenced on vaginal progesterone

D

EXPERIMENTAL

Vaginal pessary treatment in singleton pregnancy with short cervix; Women with cervix \<15 mm will be commenced on vaginal progesterone

Device: Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003)

Interventions

Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003) DEVICE

Inserted from randomization till 36-37 weeks of gestation

Also known as: Vaginal pessary, CE0482, MED/CERT ISO 9003 / EN 46003

B; D

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women with singleton pregnancies and with a cervical length of 25 mm or less
• Women with twin pregnancies

You may not qualify if:

• 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.
• Painful regular uterine contractions, history of ruptured membranes, or prophylactic cerclage before randomization.
• Patients who are unconscious, severely ill, mentally handicapped or under the age of 16 years.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (24)

Medical University of Vienna-department of Obstetrics and Gynaecology

Vienna, 1090, Austria

Location

Universidade Federal Fluminense - Hospital Universitário Antônio Pedro

Niterói, Rio de Janeiro, 24033-900, Brazil

Location

University of Campinas

São Paulo, Brazil

Location

Hospital Clinico Universidad de Chile

Santiago, Chile

Location

Hospital San Jose

Bogotá, Colombia

Location

Hospital Universitario San Vicente de Paúl

Medellín, Colombia

Location

Virchow Clinic Charite

Berlin, Germany

Location

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Fernandez Hospital, Bogulkunta,

Bogulkunta, 500001, India

Location

Ospedale Valduce

Como, Lombardy, 22100, Italy

Location

Maternidade Dr. Alfredo da Costa

Lisbon, Portugal

Location

Hospital San Teotonio

Viseu, Portugal

Location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Hospital Universitario Materno Infantil de Canarias

Las Palmas de Gran Canaria, Canary Islands, 35016, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Virgen de La Arrixaca

Murcia, Spain

Location

Heatherwood and Wexham Park Hospitals, Wexham Park Hospital

Slough, Berkshire, SL2 4HL, United Kingdom

Location

Barking, Havering and Redbridge Hospitals NHS Trust

Romford, Essex, RM7 0AG, United Kingdom

Location

Southend Hospital NHS Trust

Essex, SS0 0RY, United Kingdom

Location

The Medway Maritime Hospital NHS Trust

Kent, ME7 5NY, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

The Lewisham Hospital NHS Trust

London, SE13 6LH, United Kingdom

Location

Queen Elizabeth Hospital NHS Trust

London, SE18 4QH, United Kingdom

Location

King's College Hospital NHS Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Pessaries

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Kypros H Nicolaides, Professor

  Consultant,Director of the Department of Fetal Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

CL (1); GB (8); HK (1); SL (1); CO (2); BR (2); DE (1); AU (1); IT (1); PT (2); ES (3); IN (1)