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.: PACTR202408671139802 Date of Approval: 08/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized controlled study of effectiveness of labetalol versus hydralazine in the management of severe pre-eclampsia in Ahmadu Bello university teaching hospital, Zaria.
Official scientific title A randomized controlled study of effectiveness, maternal and perinatal outcomes in the use of labetalol versus hydralazine in the management of severe pre-eclampsia in Ahmadu Bello university teaching hospital, Zaria.
Brief summary describing the background and objectives of the trial BACKGROUND: Pre-eclampsia is a common complication of pregnancy associated with increased morbidity and mortality globally and has a significant economic burden on healthcare systems. demise. A prompt control of blood pressure is of crucial importance to prevent sequel of the disease. Pregnant women with severe pre-eclampsia can have blood pressure controlled with anti-hypertensive drugs, but the most effective anti-hypertensive medication during pregnancy is unknown. Till date, there is no consensus for reliable conclusions concerning the comparative effects of Hydralazine and Labetalol in controlling severe hypertension in pregnancy. Intravenous Hydralazine is the most frequently used anti-hypertensive for blood pressure control in severe pre-eclampsia in Ahmadu Bello University Teaching Hospital, Zaria. OBJECTIVE: To compare the effectiveness of intravenous Labetalol and intravenous Hydralazine in the management of severe pre-eclampsia in Ahmadu Bello University Teaching Hospital, Zaria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LabetHydralzn
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Preeclampsia
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/06/2022
Actual trial start date 22/08/2022
Anticipated date of last follow up 19/12/2022
Actual Last follow-up date 23/08/2023
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
Publication URL https://npmcn.edu.ng
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous Labetalol Experimental group: This group will receive intravenous Labetalol 20mg bolus, then 40mg if not effective within 20 minutes, then 80mg every 20 minutes until systolic blood pressure becomes <160mmHg and diastolic blood pressure <110mmHg up to a maximum total dose of 300mg (total of 5 bolus doses). 20 minutes The experimental group receives labetalol Experimental group: This group will receive intravenous Labetalol 20mg bolus, then 40mg if not effective within 20 minutes, then 80mg every 20 minutes until systolic blood pressure becomes <160mmHg and diastolic blood pressure <110mmHg up to a maximum total dose of 300mg (total of 5 bolus doses). 50
Control Group Intravenous hydralazine Control group: this group will receive intravenous Hydralazine, 5mg slowly over 20 minutes. If systolic blood pressure remain ≥160mmHg or diastolic blood pressure ≥110mmHg after 20 minutes, then a second bolus is given. Similarly, if after 20 minutes systolic blood pressure is still ≥160 or diastolic blood pressure ≥110mmHg, then a third dose is given and it is continued in this manner to a maximum of 30mg 20 minutes Control group: this group will receive intravenous Hydralazine, 5mg slowly over 20 minutes. If systolic blood pressure remain ≥160mmHg or diastolic blood pressure ≥110mmHg after 20 minutes, then a second bolus is given. Similarly, if after 20 minutes systolic blood pressure is still ≥160 or diastolic blood pressure ≥110mmHg, then a third dose is given and it is continued in this manner to a maximum of 30mg 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Severe hypertension (systolic blood pressure of 160mmHg or more and /or diastolic blood pressure of 110mmHg or more) and Proteinuria of 2+ or more as measured by dipstick in a catheter specimen urine sample. 2. Pregnancy ≥ 28 weeks gestation. 3. Singleton pregnancy. 4. Live fetus with normal fetal heart rate. 1. Medical disorders like asthma, cardiac failure, heart block, cardiac arrhythmias. 2. Contraindication or known allergy to hydralazine or labetalol neurological disease. 3. Fetal congenital abnormality. 4. Women who refuse consent. 5. Referrals already on anti-hypertensive. Adult: 19 Year-44 Year 18 Year(s) 45 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 26/11/2021 Health research ethics committee
Ethics Committee Address
Street address City Postal code Country
Shika, Zaria Zaria 810103 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome Number of doses/ total dosage, unit drop in systolic blood pressure and diastolic blood pressure after each administered dose, time to achieve target of blood pressure which is systolic blood pressure of 140–150 mmHg and diastolic blood pressure of 90–100 mmHg as end point of effectiveness and non-attainment of target blood pressure after stipulated maximum dosage. During and post intervention
Secondary Outcome 1 Persistent severe hypertension and requirement of additional drug to control blood pressure. 2 Medication-related undesirable effects on both mother and baby. During and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmadu Bello University Teaching Hospital Zaria Zaria-Sokoto road, Giwa Zaria PMB 06, Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Sakina Ghazali 26 Circular road, GRA, Kaduna Zaria 810103 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sakina Ghazali No 26 Circular Road, GRA, Zaria Zaria 810103 Nigeria Nil
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sakina Ghazali sakinatughz@gmail.com +2348039422550 26 Circular Road, GRA, Zaria
City Postal code Country Position/Affiliation
Zaria 810103 Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Nana Madugu madugu20007@yahoo.com +2348035896570 Shika, Zaria
City Postal code Country Position/Affiliation
Zaria 810103 Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Adebiyi Adesiyun biyi.adesiyun@yahoo.com +2348037861630 Shika, Zaria
City Postal code Country Position/Affiliation
Zaria 810103 Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from this study may be made available to qualified researchers who have a scholarly interest in pre-eclampsia. PHI will not be included in the exchanged data or samples, which will be coded. Before exchanging data with the asking party, the request must be approved and any relevant contracts (such as a material transfer agreement) must be signed. Study Protocol Data can be requested starting from nine months after an item is published, and it will be available for up to 24 months. Extension will be evaluated on an individual basis. Qualified researchers doing scientific research may seek access to the trial IPD; access will be granted following assessment and approval of a study proposal, statistical analysis plan (SAP), and execution of a data sharing agreement (DSA). For more information please contact sakinatughz@gmail.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://npmcn.edu.ng 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