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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735137
• Other study ID #: 07/HW/10
• Secondary ID: ISRCTN01096902
• Status: Completed
• Phase: Phase 3
• Start date: August 2008
• Est. completion date: February 2012

Study information

• Verified date: February 2021
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2109
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Device:
• Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003)
Inserted from randomization till 36-37 weeks of gestation

Locations

Country	Name	City	State
Austria	Medical University of Vienna-department of Obstetrics and Gynaecology	Vienna
Brazil	Universidade Federal Fluminense - Hospital Universitário Antônio Pedro	Niteroi	Rio De Janeiro
Brazil	University of Campinas	Sao Paulo
Chile	Hospital Clinico Universidad de Chile	Santiago
Colombia	Hospital San Jose	Bogota
Colombia	Hospital Universitario San Vicente de Paúl	Medellin
Germany	Virchow Clinic Charite	Berlin
Hong Kong	Chinese University of Hong Kong	Hong Kong
India	Fernandez Hospital, Bogulkunta,	Bogulkunta
Italy	Ospedale Valduce	Como	Lombardy
Portugal	Maternidade Dr. Alfredo da Costa	Lisbon
Portugal	Hospital San Teotonio	Viseu
Slovenia	University Medical Centre Ljubljana	Ljubljana
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario Materno Infantil de Canarias	Las Palmas de Gran Canaria	Islas Canarias
Spain	Virgen de La Arrixaca	Murcia
United Kingdom	Southend Hospital NHS Trust	Essex
United Kingdom	The Medway Maritime Hospital NHS Trust	Kent
United Kingdom	King's College Hospital NHS Trust	London
United Kingdom	Queen Elizabeth Hospital NHS Trust	London
United Kingdom	The Lewisham Hospital NHS Trust	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London
United Kingdom	Barking, Havering and Redbridge Hospitals NHS Trust	Romford	Essex
United Kingdom	Heatherwood and Wexham Park Hospitals, Wexham Park Hospital	Slough	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Countries where clinical trial is conducted

Austria,  Brazil,  Chile,  Colombia,  Germany,  Hong Kong,  India,  Italy,  Portugal,  Slovenia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be spontaneous delivery from randomization to 33 weeks and 6 days (237 days) of gestation.		10 weeks
Secondary	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

External Links

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