Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
516.4
Study information
Scientific title
Acronym
SIP
Study hypothesis
17-hydroxyprogesterone caproate in conjunction with standard tocolysis may increase the latency period in preterm labour.
Please note that as of 24/06/2008 more details on the sources of funding have been added to this record (i.e., funding now confirmed). This can be seen below in the sources of funding section.
Ethics approval
University of Malaya Medical Centre Medical Ethics Committee, 19/07/2006
Study design
Randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Preterm labour
Intervention
Single injection of 250 mg of 17-hydroxyprogesterone acetate versus placebo saline injection.
Intervention type
Drug
Phase
Not Specified
Drug names
17-hydroxyprogesterone caproate
Primary outcome measure
1. Delivery within 48 hours
2. Delivery within seven days
Secondary outcome measures
1. Delivery before 34 weeks
2. Delivery before 37 weeks
3. Mode delivery
4. Birth weight
5. Gestational age at delivery
6. Apgar score (five minute)
7. Umbilical cord blood pH at birth
8. Admission to the neonatal unit
9. Perinatal mortality
10. Neonatal morbidity including Respiratory Distress Syndrome (RDS), IntraVentricular Haemorrhage (IVH), Necrotising EnteroColitis (NEC), surfactant use, mechanical ventilation
Overall trial start date
15/02/2007
Overall trial end date
15/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Suspected preterm labour (based on presence of contractions and/or cervical changes)
2. 22 to 35 weeks gestation
3. Scheduled for standard tocolysis and prophylactic antenatal corticosteroids
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
256
Participant exclusion criteria
1. Multiple gestations
2. Foetal death
3. Membrane rupture
4. Maternal pyrexia more than 38°C
5. Indications for immediate delivery
Recruitment start date
15/02/2007
Recruitment end date
15/02/2009
Locations
Countries of recruitment
Malaysia
Trial participating centre
Department of Obstetrics and Gynaecology
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya Medical Centre (Malaysia)
Sponsor details
Lembah Pantai
Kuala Lumpur
59100
Malaysia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Malaya (Malaysia) (ref: PJP/F0174/2007B)
Alternative name(s)
University of Malaya
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Malaysia
Funder name
CCM Duopharma Malaysia Biotech Berhad (Malaysia) - supply of trial medication
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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