Single Injection 17-hydroxyprogesterone caproate in Preterm labour: a randomised controlled trial

ISRCTN	ISRCTN22145023
DOI	https://doi.org/10.1186/ISRCTN22145023
Protocol serial number	516.4
Sponsor	University of Malaya Medical Centre (Malaysia)
Funders	University of Malaya (Malaysia) (ref: PJP/F0174/2007B), CCM Duopharma Malaysia Biotech Berhad (Malaysia) - supply of trial medication

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Peng Chiong Tan
Scientific

Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SIP
Study objectives	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(s)	University of Malaya Medical Centre Medical Ethics Committee, 19/07/2006
Health condition(s) or problem(s) studied	Preterm labour
Intervention	Single injection of 250 mg of 17-hydroxyprogesterone acetate versus placebo saline injection.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	17-hydroxyprogesterone caproate
Primary outcome measure(s)	1. Delivery within 48 hours 2. Delivery within seven days
Key secondary outcome measure(s)	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
Completion date	15/02/2009

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	256
Key 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
Key exclusion criteria	1. Multiple gestations 2. Foetal death 3. Membrane rupture 4. Maternal pyrexia more than 38°C 5. Indications for immediate delivery
Date of first enrolment	15/02/2007
Date of final enrolment	15/02/2009

Department of Obstetrics and Gynaecology

Kuala Lumpur
50603
Malaysia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan