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.: PACTR201707002463243 Date of Approval: 24/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Labetalol for chronic hypertension
Official scientific title Methyldopa versus Labetalol or no medication for treatment of chronic hypertension during pregnancy: a double blinded randomized clinical trial.
Brief summary describing the background and objectives of the trial to assess the maternal and fetal outcome in women with mild to moderate chronic hypertension on antihypertensive drug (methyldopa or labetalolol) therapy compared to no medication.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Pregnancy and Childbirth,Treatment of chronic hypertension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial antihypertensive drug
Anticipated trial start date 01/08/2017
Actual trial start date 01/08/2017
Anticipated date of last follow up 01/08/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 480
Actual target sample size (number of participants) 480
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Methyldopa group 1-2 gm per day in divided doses throughout pregnancy treatment 160
Experimental Group Labetalol group 100-300 mg per day in divided doses throughout pregnancy treatment 160
Control Group no medication group 1-2 tablets daily throughout pregnancy treatment 160 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women diagnosed with mild to moderate chronic hypertension, with systolic blood pressure of 140¿159 mmHg or diastolic blood pressure of 90¿109 mmHg, at the beginning of pregnancy were included in the study. Women with multiple pregnancies, women with proteinuria at less than 20 weeks¿ gestation, women having other associated medical disorders as diabetes mellitus, bronchial asthma & epilepsy and pregnancies complicated by fetal malformations were excluded from the study. 20 Year(s) 40 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 17/07/2017 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome maternal outcome throughout pregnancy till end of puerperium
Primary Outcome Fetal-neonatal outcome throughout pregnancy till one month after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
Central hospitals in Menoufia governortae 11 cities Shibin Elkom-Elbajour-Berket Elsabie-Elshodaa-Menouf-Ashmoun 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt assistant professor of Obstetrics and Gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information