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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2780 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Randomized Study of Pessary vs Standard Management in Women With Increased Chance of Premature Birth
Study Start Date :	August 2008
Estimated Primary Completion Date :	October 2011
Estimated Study Completion Date :	February 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. The primary outcome measure will be spontaneous delivery from randomization to 33 weeks and 6 days (237 days) of gestation. [ Time Frame: 10 weeks ]

Secondary Outcome Measures :

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) [ Time Frame: Within the first year ]

Eligibility Criteria

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Ages Eligible for Study:	16 Years to 45 Years (Child, Adult)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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
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
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
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

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	August 14, 2008
Last Update Posted:	November 3, 2009
Last Verified:	November 2009

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