Condition category
Pregnancy and Childbirth
Date applied
22/01/2007
Date assigned
02/02/2007
Last edited
10/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peng Chiong Tan

ORCID ID

Contact details

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

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 measures

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

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

http://www.ummc.edu.my

Funders

Funder type

University/education

Funder name

University of Malaya (Malaysia) (ref: PJP/F0174/2007B)

Alternative name(s)

University of Malaya, UM

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes