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

ISRCTN	ISRCTN22145023
DOI	https://doi.org/10.1186/ISRCTN22145023
Secondary identifying numbers	516.4

Submission date: 22/01/2007
Registration date: 02/02/2007
Last edited: 10/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

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

Contact information

Dr Peng Chiong Tan
Scientific

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

Study information

Study design	Randomised double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	15/02/2007
Completion date	15/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Locations

Countries of recruitment

Malaysia

Study participating centre

Department of Obstetrics and Gynaecology

Kuala Lumpur
50603
Malaysia

Sponsor information

University of Malaya Medical Centre (Malaysia)
University/education

Lembah Pantai
Kuala Lumpur
59100
Malaysia

Website	http://www.ummc.edu.my
"ROR"	https://ror.org/00vkrxq08

Funders

Funder type

University/education

University of Malaya (Malaysia) (ref: PJP/F0174/2007B)
Government organisation / Universities (academic only)

Alternative name(s): University of Malaya, University Malaya, Malayan University, UM
Location: Malaysia

CCM Duopharma Malaysia Biotech Berhad (Malaysia) - supply of trial medication

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan