Randomized Study of Pessary Versus Standard Management in Women With Increased Chance of Premature Birth
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ClinicalTrials.gov Identifier: NCT00735137 |
Recruitment Status
: Unknown
Verified November 2009 by King's College Hospital NHS Trust.
Recruitment status was: Recruiting
First Posted
: August 14, 2008
Last Update Posted
: November 3, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preterm Birth | Device: Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003) | Phase 3 |
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 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 |
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
|
- The primary outcome measure will be spontaneous delivery from randomization to 33 weeks and 6 days (237 days) of gestation. [ Time Frame: 10 weeks ]
- 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 ]

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Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women with singleton pregnancies and with a cervical length of 25 mm or less
- Women with twin pregnancies
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735137
Contact: Kypros Nicolaides, Professor | +442032999000 ext 8256 | kypros@fetalmedicine.com |
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 |
Study Director: | Kypros H Nicolaides, Professor | Consultant,Director of the Department of Fetal Medicine |
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 Key Record Dates |
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 |