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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202503593160636 Date of Registration: 31/03/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Oral Labetalol Versus Oral Nifedipine for Controlling Hypertension in Postnatal Women in Enugu: A Multi-centre Randomised Controlled Study
Official scientific title Oral Labetalol Versus Oral Nifedipine for Controlling Hypertension in Postnatal Women in Enugu: A Multi-centre Randomised Controlled Study
Brief summary describing the background and objectives of the trial Hypertension is the most common medical disease in pregnancy, and complicates about 1 in 10 pregnancies. It is one of the commonest causes of maternal morbidity and mortality. With the current trend of delayed motherhood, obesity epidemic and use of in-vitro fertilization, it is expected that the incidence will increase. When hypertension is poorly controlled, it poses a great cardiovascular risk, causes anxiety to the patient and the carers, delays hospital discharge with its economic implication. This underscores the importance of pragmatic approach to management of hypertension at all levels. However, there is great paucity of evidence to guide antihypertensive choice during postpartum period. Hence, we chose to compare the efficacy of two antihypertensives in the postpartum period in order to help provide evidence in this regard. The objectives are to determine and compare the average time interval taken to achieve blood pressure control (defined as systolic of 110 to 140mmHg and diastolic of 70 to 90mmHg for at least 24 hours) between the use of long-acting oral nifedipine and oral labetalol in control of hypertension in postnatal women in Enugu, to determine and compare the average direct cost of procuring antihypertensives between the use of long-acting oral nifedipine and oral labetalol in control of hypertension in postnatal women in Enugu, to determine and compare the proportion of participants with the need for additional antihypertensive agents between the use of long-acting oral nifedipine and oral labetalol in control of hypertension in postnatal women in Enugu and to determine and compare patient reported side effects recorded following the use of long-acting oral nifedipine or oral labetalol in control of hypertension in postnatal women in Enugu
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/01/2025
Actual trial start date
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oral administration of labetalol 200mg 12 hourly up to a maximum of 1400mg in 24 hours Until blood pressure control is achieved Once a postpartum woman is noted to have BP ≥150/100 and she meets the inclusion criteria, she will be counselled and her informed consent obtained. if allocated to group A,they will recieve will receive oral labetalol 200mg 12 hourly. They will also receive alpha methyldopa 250mg 8 hourly Blood pressure information will be reviewed every 4 hours and increment made every 24 hours where necessary. If the maximum dose of any of the two drugs is reached without BP control, a third antihypertensive will be added starting with the minimum dose. Target BP is systolic of 110 to 140mmHg and diastolic of 70 to 90mmHg sustained for 24 hours. The use of Magnesium sulphate for seizure prophylaxis and the need/use of parenteral antihypertensive will be at the discretion of the managing unit. 25
Control Group Oral administration of Nifedipine 30mg Until blood pressure control is achieved Once a postpartum woman is noted to have BP ≥150/100 and she meets the inclusion criteria, she will be counselled and her informed consent obtained. if allocated to group B, will recieve long acting oral nifedipine 30mg daily. They will also receive alpha methyldopa 250mg 8 hourly. Blood pressure information will be reviewed every 4 hours and increment made every 24 hours where necessary. If the maximum dose of any of the two drugs is reached without BP control, a third antihypertensive will be added starting with the minimum dose. Target BP is systolic of 110 to 140mmHg and diastolic of 70 to 90mmHg sustained for 24 hours. The use of Magnesium sulphate for seizure prophylaxis and the need/use of parenteral antihypertensive will be at the discretion of the managing unit. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women who delivered after 28 weeks of gestation irrespective of route of delivery and their blood pressures postpartum were ≥150/100mmHg. All women who give their consent to participate in the research 1. Women with known allergy to either nifedipine or labetalol 2. Sickle cell disease patients 3. Hypertensive women with previous/family history of depression or psychiatric illness 4. Women with hypertensive emergency (defined as BP ≥ 180/120 mmHg). 5. Known asthmatic patients 6. Women with other co-morbidities like diabetes mellitus, renal failure, heart failure, heart block etc in the pregnancy 7. Women with morbid obesity Adult: 18 Year(s)-44 Year(s) 18 Year(s) 50 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 14/01/2025 The ethical committee of ESUT Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Parklane, Enugu Enugu 100004 Nigeria
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 23/01/2025 Mother of Christ Specialist Hospital Health Research Ethics Committe
Ethics Committee Address
Street address City Postal code Country
Ogui, Enugu Enugu 100004 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is the average time interval taken to achieve blood pressure control sustained for 24 hours Time of commencement of intervention to time of achieving blood pressure control
Secondary Outcome To compare the potential need for dose escalation when using long-acting oral nifedipine versus oral labetalol for hypertension management in postnatal women in Enugu. To determine and compare the proportion of participants with the need for additional antihypertensive agents between the use of long-acting oral nifedipine and oral labetalol in control of hypertension in postnatal women in Enugu. To determine and compare patient reported side effects recorded following the use of long-acting oral nifedipine or oral labetalol in control of hypertension in postnatal women in Enugu Time of commencement of intervention to time of achieving blood pressure control
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ESUT Teaching Hospital Enugu Parklane road G R A Enugu Enugu Nigeria
Mother of Christ Specialist Hospital Enugu Ogui Road Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ogbonna Enoch ESUTH, Parklane, GRA Enugu 100004 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self ESUTH, Parklane, GRA Enugu 100004 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Enoch Ejiofor Ogbonna nocheji@gmail.com +2348036943260 Parklane, GRA
City Postal code Country Position/Affiliation
Enugu 100004 Nigeria Senior Registrar. ESUTH teaching Hospital Parklane GRA Enugu
Role Name Email Phone Street address
Scientific Enquiries Joseph Tochukwu Enebe drenebe2002@yahoo.co.uk +2348064065851 Parklane, GRA
City Postal code Country Position/Affiliation
Enugu 100004 Nigeria consultant EUTH Parklane GRA Enugu
Role Name Email Phone Street address
Public Enquiries Ifeanyi Johnson Onyekpa ifeanyionyekpa@gmail.com +2348064086359 ESUTH Parklane GRA
City Postal code Country Position/Affiliation
Enugu 100004 Nigeria Consultant ESUTH Parklane GRA Enugu
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes i. Will the data be shared? Yes, individual participant data (IPD) will be shared. ii. What data will be shared? De-identified individual participant data, including baseline characteristics, outcome measures, and adverse event data. iii. When will the data be available? The data will be available beginning immediately after publication of the main results and for a period of 5 years thereafter. iv. Who can access the data? Qualified researchers affiliated with academic institutions, healthcare organizations, or research institutions. v. For what purpose? Data will be shared for the purpose of further research, meta-analyses, and validation of study findings. vi. How to access the data? Interested researchers must submit a formal request to the host journal and provide a study proposal outlining the intended use of the data. Access will be granted upon ethical review and approval Informed Consent Form The data will be available beginning immediately after publication of the main results and for a period of 5 years thereafter. Interested researchers must submit a formal request to the host journal and provide a study proposal outlining the intended use of the data. Access will be granted upon ethical review and approval
URL Results Available Results Summary Result Posting Date First Journal Publication Date
this will be inluded following article publication 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 31/01/2025 Changed to lower case ORAL LABETALOL VERSUS ORAL NIFEDIPINE FOR CONTROLLING HYPERTENSION IN POSTNATAL WOMEN IN ENUGU: A MULTI-CENTRE RANDOMISED CONTROLLED STUDY Oral Labetalol Versus Oral Nifedipine for Controlling Hypertension in Postnatal Women in Enugu: A Multi-centre Randomised Controlled Study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 31/01/2025 Changed to lower case ORAL LABETALOL VERSUS ORAL NIFEDIPINE FOR CONTROLLING HYPERTENSION IN POSTNATAL WOMEN IN ENUGU: A MULTI-CENTRE RANDOMISED CONTROLLED STUDY Oral Labetalol Versus Oral Nifedipine for Controlling Hypertension in Postnatal Women in Enugu: A Multi-centre Randomised Controlled Study
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 31/01/2025 Each criteria on a new line Women who delivered after 28 weeks of gestation irrespective of route of delivery and their blood pressures postpartum were ≥150/100mmHg. All women who give their consent to participate in the research Women who delivered after 28 weeks of gestation irrespective of route of delivery and their blood pressures postpartum were ≥150/100mmHg. All women who give their consent to participate in the research
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/02/2025 Addition of date of ethical approval FALSE, The ethical committee of ESUT Teaching Hospital, Parklane, Enugu , Enugu, 100004, Nigeria, 27 Nov 2024, , +2348060568724, esuthhrec@gmail.com, 32149_30267_4737.pdf TRUE, The ethical committee of ESUT Teaching Hospital, Parklane, Enugu , Enugu, 100004, Nigeria, 27 Nov 2024, 14 Jan 2025, +2348060568724, esuthhrec@gmail.com, 32149_30267_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/03/2025 The ethics chairman approved my application but before the certificate could be processed he went on annual leave and had to sign the certificate whe he resum ed duty TRUE, Mother of Christ Specialist Hospital Health Research Ethics Committe, Ogui Enugu, Enugu, 100004, Nigeria, , 23 Jan 2025, +2348032802070, mother_christ@yahoo.com, 32149_30459_4737.pdf TRUE, Mother of Christ Specialist Hospital Health Research Ethics Committe, Ogui, Enugu, Enugu, 100004, Nigeria, , 23 Jan 2025, +2348032802070, mother_christ@yahoo.com, 32149_30459_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 01/02/2025 Name of source of fund Self, ESUTH, Parklane, GRA, Enugu, 100004, Nigeria, Self Funded, Dr Ogbonna Enoch, ESUTH, Parklane, GRA, Enugu, 100004, Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 19/03/2025 to update required information Thje IPD will be shared during publication of manuscript emanating from the study. The IDP will be shared through the journal publishing the work i. Will the data be shared? Yes, individual participant data (IPD) will be shared. ii. What data will be shared? De-identified individual participant data, including baseline characteristics, outcome measures, and adverse event data. iii. When will the data be available? The data will be available beginning immediately after publication of the main results and for a period of 5 years thereafter. iv. Who can access the data? Qualified researchers affiliated with academic institutions, healthcare organizations, or research institutions. v. For what purpose? Data will be shared for the purpose of further research, meta-analyses, and validation of study findings. vi. How to access the data? Interested researchers must submit a formal request to the host journal and provide a study proposal outlining the intended use of the data. Access will be granted upon ethical review and approval
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 01/02/2025 addition of time frame Immediately after completion of work and publication of study results begining 2 months and ending 1 year following article publication
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 19/03/2025 to update required information begining 2 months and ending 1 year following article publication The data will be available beginning immediately after publication of the main results and for a period of 5 years thereafter.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 19/03/2025 to update required information it will be avialble to all freely Interested researchers must submit a formal request to the host journal and provide a study proposal outlining the intended use of the data. Access will be granted upon ethical review and approval
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 01/02/2025 information on URL provided this will be inluded following article publication