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02 September 2010
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| [ Print-friendly version ] |
| Randomised study of pessary vs standard management in women with increased chance of premature birth |
| ISRCTN | ISRCTN01096902 |
| ClinicalTrials.gov identifier | NCT00735137 |
| Public title | Randomised study of pessary vs standard management in women with increased chance of premature birth |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 07WH10 |
| Study hypothesis |
This trial record has been extensively amended as of 12/08/2008. The changes include the following:
1. The trial title has been changed from "Randomised study of pessary vs expectant management in twins" to "Randomised study of pessary vs standard management in women with increased chance of premature birth" 2. The information given in the disease/condition/study domain has been changed from "Premature birth in twins pregnancy" to "Premature birth in women with increased risk of premature birth" 3. The target number of participants has been changed from 1,180 to 2,780 (1,180 twin pregnancies and 1,600 singleton pregnancies) Other changes are recorded in the relevant fields under the date on which the amendments were made. Current hypothesis as of 12/08/2008: Is pessary useful in reducing risk of premature birth in women with singleton pregnancies with a short cervix (cervical length of 25 mm or less at 21-24 weeks) or in twin pregnancies? Previous hypothesis: Is pessary useful in reducing the risk of premature birth in twin pregnancy? |
| Ethics approval | King's College Hospital Research Ethics Committee. Date of approval: 31/01/2008 (ref: 08/H0808/3) |
| Study design | Multi-centre randomised controlled trial. |
| Countries of recruitment | Brazil, Chile, Colombia, Portugal, Spain, United Kingdom |
| Disease/condition/study domain |
Premature birth in women with increased risk of premature birth
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| Participants - inclusion criteria |
Current inclusion criteria as of 12/08/2008:
1. Women with singleton pregnancies and with a cervical length of 25 mm or less 2. Women with twin pregnancies Previous inclusion criteria: 1. Women with twin pregnancies undergoing routine ultrasonography at 20-24+6 weeks of gestation for examination of foetal anatomy and growth 2. Both foetuses are found to be alive with no major abnormalities, severe twin to twin transfusion syndrome or severe foetal growth restriction |
| Participants - exclusion criteria |
Current exclusion criteria as of 12/08/2008:
1. Major foetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), foetal death, severe twin to twin transfusion syndrome or severe foetal growth restriction in one of the foetuses (in the case of twin pregnancy) diagnosed before randomisation 2. Painful regular uterine contractions, history of ruptured membranes, or prophylactic cerclage before randomisation 3. Patients who are unconscious, severely ill, mentally handicapped or under the age of 16 years Previous exclusion criteria: 1. Major foetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), or death of one or both of the foetuses, severe twin to twin transfusion syndrome diagnosed before randomisation 2. Painful regular uterine contractions, history of ruptured membranes, or prophylactic cerclage before randomisation 3. Patients who are unconscious, severely ill or mentally handicapped 4. Under the age of 16 years |
| Anticipated start date | 15/04/2008 |
| Anticipated end date | 15/04/2012 |
| Status of trial | Ongoing |
| Patient information material | Patient information sheet for women with singleton pregnancies can be found at http://www.fetalmedicine.com/research/prem-single-info.htm. Patient information sheet for women with twin pregnancies can be found at http://www.fetalmedicine.com/research/prem-twins-info.htm. |
| Target number of participants | 2,780 (1,180 twin pregnancies and 1,600 singleton pregnancies) |
| Interventions | Treatment with insertion of vaginal pessary vs expectant management. The vaginal pessary is inserted in those allocated to this group within 5 days after the 20-24+6 weeks scan. The pessary will be removed by a simple vaginal examination before delivery. |
| Primary outcome measure(s) | Spontaneous delivery before 34 weeks of gestation. |
| Secondary outcome measure(s) |
1. Birth weight (mean, less than 2.5 kg and less than 1.5 kg)
2. Foetal or neonatal death 3. Major adverse outcomes before discharge from the hospital (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity or necrotising entercolitis) 4. Need for neonatal special care (admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis or blood transfusion). Duration of follow-up: 2 years |
| Sources of funding | Fetal Medicine Foundation (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Kypros Nicolaides |
| Address |
Harris Birthright Research Centre for Fetal Medicine
King's College Hospital Denmark Hill |
| City/town | London |
| Zip/Postcode | SE5 9RS |
| Country | United Kingdom |
| Sponsor | King's College Hospital NHS Foundation Trust (UK) |
| Address |
Directorate of Research and Development
King's College Hospital Denmark Hill |
| City/town | London |
| Zip/Postcode | SE5 9RS |
| Country | United Kingdom |
| Sponsor website: | http://www.kch.nhs.uk |
| Date applied | 05/04/2008 |
| Last edited | 01/12/2008 |
| Date ISRCTN assigned | 28/05/2008 |
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