Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00735137
Protocol/serial number
07WH10
Study information
Scientific title
Randomised study of pessary vs standard management in women with increased chance of premature birth
Acronym
Study hypothesis
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, 31/01/2008, ref: 08/H0808/3
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
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.
Condition
Premature birth in women with increased risk of premature birth
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Spontaneous delivery before 34 weeks of gestation
Secondary outcome measures
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
Overall trial start date
15/04/2008
Overall trial end date
15/04/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
2,780 (1,180 twin pregnancies and 1,600 singleton pregnancies)
Participant 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
Recruitment start date
15/04/2008
Recruitment end date
15/04/2012
Locations
Countries of recruitment
Brazil, Chile, Colombia, Portugal, Spain, United Kingdom
Trial participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
King's College Hospital NHS Foundation Trust (UK)
Sponsor details
Directorate of Research and Development
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Fetal Medicine Foundation (UK)
Alternative name(s)
FMF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26321037
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26981934