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.: PACTR202010738538062 Date of Approval: 01/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title COMPARISON OF INTRAVENOUS LABETALOL AND HYDRALAZINE FOR THE CONTROL OF SEVERE HYPERTENSION IN PREGNANCY: A RANDOMIZED CONTROLLED TRIAL
Official scientific title COMPARISON OF INTRAVENOUS LABETALOL AND HYDRALAZINE FOR THE CONTROL OF SEVERE HYPERTENSION IN PREGNANCY: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial ABSTRACT BACKGROUND Hypertensive disorders in pregnancy complicate 11-22% of pregnancies and are among the leading causes of maternal mortality. Maternal death is more commonly associated with complications of severe hypertension, which is defined as systolic blood pressure of at least 160 mmHg and diastolic blood pressure of at least 110 mmHg. Such complications include cerebral injury, renal impairment and cardiac failure. Placental abruption is also a complication, which can in addition lead to fetal demise. Control of severe hypertension in pregnancy is therefore a key aspect of preventing adverse outcome. Intravenous hydralazine is commonly used as a drug of choice. However, it is associated with maternal hypotension and other unpleasant side effects. Intravenous labetalol is an alternative but there is limited experience with its use at Federal Teaching Hospital Gombe and State Specialist Hospital Gombe. This study will compare the efficacy of labetalol in comparison to hydralazine and its safety for the control of severe hypertension in pregnancy. OBJECTIVES The primary objectives were to compare the mean reduction in mean arterial blood pressure between the two drugs and the rates of persistent hypertension with each. METHODS The study is a superiority double-blind randomized controlled trial in which 120 women with severe hypertension (systolic and diastolic blood pressures of at least 160mmHg and 110mmHg respectively) in pregnancy were randomized to either of two groups. One group received intravenous labetalol in incremental doses of 20mg, 40mg, 80mg, 80mg, and 80mg (maximum cumulative dose of 300mg) every 20 minutes until the target blood pressure of <160/110mmHg was reached. The other group received intravenous hydralazine 10 mg intravenously up to a maximum of 5 doses, repeated every 20 minutes until the target blood pressure was reached. The primary outcome measures were mean reduction in mean arterial blood pressure and the number of patients with persistent hypertension, while the secondary outcome measures were the occurrence of maternal hypotension, other maternal adverse effects and the neonatal outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Severe hypertension in pregnancy
Purpose of the trial Treatment: Drugs
Anticipated trial start date 14/10/2018
Actual trial start date 14/10/2018
Anticipated date of last follow up 20/06/2019
Actual Last follow-up date 20/06/2019
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 113
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intravenous Hydralazine intravenous hydralazine 10 mg intravenously up to a maximum of 5 doses, repeated every 20 minutes until the target blood pressure was reached. repeated every 20 minutes until the target blood pressure was reached. Intravenous hydralazine employed was imported by Naman Pharmacy Drugs with Batch number HH-1501, manufacturing date 09/2015, and expiry date of 08/2019. 56 Active-Treatment of Control Group
Experimental Group Intravenous Labetalol intravenous labetalol in incremental doses of 20mg, 40mg, 80mg, 80mg, and 80mg (maximum cumulative dose of 300mg) every 20 minutes until the target blood pressure of <160/110mmHg was reached up to a maximum of 300mg. every 20 minutes until the target blood pressure of <160/110mmHg was reached. The intravenous labetalol used was LabetTM. It was manufactured by Popular pharmaceuticals, Tongi, Bangladesh with Batch no, NAFDAC Registration number A4-7525. It had a manufacturing date of July, 2017 and expiry date of July, 2019. 57
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Consenting pregnant women with severe hypertension in pregnancy with systolic blood pressure (SBP) of at least 160 mmHg and/or diastolic blood pressure (DBP) of at least 110 mmHg. • Gestational age of 28 weeks or more which will be determined based on ultrasound scan or last menstrual period. • Live singleton fetus with normal fetal heart rate. • All women with cardiac disease such as heart block, ischaemic heart disease, and hypertensive cardiac disease. • Asthma • History of allergy to either hydralazine or labetalol. • Chronic medical disorder such as chronic kidney disease and diabetes mellitus. • Women with haemoglobinopathy such as HbSS. • Multiple gestation. • Preterm labour at gestational age of less than 34 weeks • Women who are already on other antihypertensive drugs. • Patients with stroke • Unconscious patients • Patients with HELLP syndrome and liver disease • Presence of fetal distress • Non consenting women Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 44 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 14/12/2017 Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
ASHAKA ROAD GOMBE 760 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean reduction in Mean Arterial Blood Pressure and rate of Persistent hypertension Twenty - 20 minutes after administration of intervention
Secondary Outcome Perinatal outcome and maternal sideeffects up to 24 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL TEACHING HOSPITAL GOMBE ASHAKA ROAD GOMBE PMB 0037 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
MUHAMMAD Sagir PMB 0037 ASHAKA ROAD GOMBE 760 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MUHAMMAD Sagir ASHAKA ROAD GOMBE Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
PROF HADIZA ABDULLAHI USMAN BAMA ROAD MAIDUGURI PMB 1414 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator SAGIR MUHAMMAD sagirmuhammad2013@gmail.com +2348034309414 ASHAKA ROAD
City Postal code Country Position/Affiliation
GOMBE Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries SAGIR MUHAMMAD sagirmuhammad2013@gmail.com +2348034309414 ASHAKA ROAD
City Postal code Country Position/Affiliation
GOMBE Nigeria DEPARTMENT OF OBS AND GYNAE SPECIALIST HOSPITAL GOMBE
Role Name Email Phone Street address
Scientific Enquiries SAGIR MUHAMMAD sagirmuhammad2013@gmail.com +2348034309414 ASHAKA ROAD
City Postal code Country Position/Affiliation
GOMBE Nigeria OBS AND GYNAE FEDERAL TEACHING HOSPITAL AND SPECIALIST HOSPITAL GOMBE
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Statistical Analysis Plan,Study Protocol Beginning 9 monthsand ending 36 months following article publication Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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