Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201405000757313 Date of Approval: 31/01/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Treatment of Preterm labour
Official scientific title Nicorandil Versus Nifedipine in the treatment of Preterm Labour: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial To compare nifedipine and the potassium channel opener Nicorandil as tocolytic drugs for preterm labor
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,preterm labour
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2014
Actual trial start date 05/02/2014
Anticipated date of last follow up 31/07/2014
Actual Last follow-up date 31/07/2014
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised using a computerized random number generator in a sequence of sealed, numbered opaque envelopes. With a 1:1 randomization ratio. sealed opaque envelops Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised using a computerized random number generator in a sequence of sealed, numbered opaque envelopes. With a 1:1 randomization ratio. sealed opaque envelops Open-label(Masking Not Used) Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oral nicorandil 20 mg oral initially followed by 10 mg at 8 hourly intervals 48 hours oral drug intake 100
Control Group Nifedipine tablets 20 mg initially followed by 10 mg every 4 hours 48 hours oral drug intake 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women who presented to the labor ward between 24 and 34 weeks of pregnancy (determined by the date of the last menstrual period when known or by early ultrasound) will be assessed for enrollment into the study. -Cervix dilatation greater than 5 cm. -Polyhydramnios [amniotic fluid index (AFI) greater than 20 cm] and oligohydramnios (AFI less than 10 cm). -Fetal macrosomia (estimated fetal weight of 4 kg or more). - Suspected intrauterine infection (a temperature greater than 38°C). -Growth restriction. -Major antepartum hemorrhage. -Major maternal medical disorders. - Multiple pregnancy. -Hypertension in pregnancy and blood pressure less than 90/50 mm Hg. -Signs of fetal distress. -Lethal fetal anomaly. -Contraindication for the use of nifedipine and/or nicorandil. 18 Year(s) 36 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/10/2012 Menoufia Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abdelghafar street shibin elkom 002048 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/10/2012 Local departmental committee
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abdelghafar street shibin elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prolongation of pregnancy for a period of 48 hours 48 hours
Secondary Outcome adverse effects of both drugs 48 hours
Secondary Outcome Prolongation of pregnancy till completed 37 weeks
Secondary Outcome Neonatal outcome till delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university hospital 25 Yasin Abdelghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia faculty of medicine 25 Yasin Abdelghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia faculty of medicine 25 Yasin Abdelghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk Kafrmanawhla elbajour 002048 Egypt
Alaa Masood Mogamaa Shibin elkom 002048 Egypt
Ragab Dawood Elmahta Quesna 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk mohamed.abdallah1975@yahoo.com +201006237186 Kafrmanawahla
City Postal code Country Position/Affiliation
elbajour 002048 Egypt lecturer at department of obstetrics and gynecology,menoufia faculty of medicine
Role Name Email Phone Street address
Public Enquiries Ragab Dawood Dr_ragabdawood@yahoo.com 00201006426492 Elmahta
City Postal code Country Position/Affiliation
Quesna 002048 Egypt lecturer at department of obstetrics and gynecology, menoufia faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Alaa Masood dralaamasoud75@yahoo.com +201001545759 Mogamaa
City Postal code Country Position/Affiliation
shibin elkom 002048 Egypt lecturer at department of obstetrics and gynecology,menoufia faculty of medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information