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.: PACTR201906662822573 Date of Approval: 19/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title AYO TRIAL
Official scientific title Oral immediate-release nifedipine versus parenteral hydralazine for controlling severe hypertension in pregnancy: a double-blind randomized trial
Brief summary describing the background and objectives of the trial Hypertensive disorders in pregnancy contribute immensely to maternal morbidity and mortality especially in the developing countries; the severe form of hypertension being the common culprit. The role of antihypertensives as one of the principles in the management of severe hypertension in pregnancy, to aid in forestalling both maternal and fetal complications, including death, cannot be overemphasized. The quest for the ideal first-line antihypertensive in the management of severe hypertension in pregnancy continues, amongst the limited choices available, which include intravenous Hydralazine and Labetalol. Currently, oral Nifedipine (immediate release form) has been added to the list by professional bodies such as American College of Obstetrics and Gynaecology (ACOG) and National Institute for Clinical Excellence (NICE). Can an oral drug be as effective as an intravenous drug in the prompt management of severe hypertension in pregnancy? This has been a resounding question that needs an answer; hence the comparison is being done worldwide, but no study has been done in Nigeria. Objective: To compare the efficacy and safety of oral Nifedipine and intravenous hydralazine in controlling severe hypertension in pregnancy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 12/06/2019
Actual trial start date
Anticipated date of last follow up 16/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group immediate release nifedipine 10mg capsule immediate-release nifedipine and a placebo hydralazine 20mg (in the form of 20mls of normal saline in a 20ml syringe Once a. 5mls of the intravenous drug was given over 5 minutes and also 1 purple capsule was given with a sip of water b. Repeat BP measurement was done after 20 minutes. If within the target blood pressure of systolic 140-150mmhg, and or diastolic 90-100mmhg, the research is deemed complete. If blood pressure is still > or = 160/110 mmHg, next step applies. 10mls of the intravenous drug was given over 5 minutes and also 2 purple capsules was given with a sip of water. Repeat BP measurement was done after 20 minutes. If within the target blood pressure of systolic 140-150mmhg, and or diastolic 90-100mmhg, the research is deemed complete. If blood pressure is still > or = 160/110 mmHg, next step applies 35
Control Group Hydralazine group Placebo 10mg immediate-release nifedipine capsule (factory made and looks exactly like the active drug) and active hydralazine (Apresoline) 20mg diluted in 20mls of water for injection in 20mls syringe Once a. 5mls of the intravenous drug was given over 5 minutes and also 1 purple capsule was given with a sip of water b. Repeat BP measurement was done after 20 minutes. If within the target blood pressure of systolic 140-150mmhg, and or diastolic 90-100mmhg, the research is deemed complete. If blood pressure is still > or = 160/110 mmHg, next step applies. 10mls of the intravenous drug was given over 5 minutes and also 2 purple capsules was given with a sip of water. Repeat BP measurement was done after 20 minutes. If within the target blood pressure of systolic 140-150mmhg, and or diastolic 90-100mmhg, the research is deemed complete. If blood pressure is still > or = 160/110 mmHg, next step applies 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. All pregnant women with systolic blood pressure of 160mmHg and above, and/or diastolic blood pressure of 110mmHg and above, that persists after 15 minutes. b. The gestational age of the pregnancy must be beyond the age of viability, which is 28 weeks in the study setting. c. All pregnant women who give their consent. a) All patients who refused to give consent for the study. b) Any pregnant woman with severe hypertension and seizures, and/ or coma (eclampsia). c) Any pregnant woman with signs of imminent eclampsia such as: severe headache, blurring of visions, epigastric pain, or reduced urinary output. d) Any pregnant woman with severe hypertension complicated by abruptio placentae, or cerebrovascular accident. e) Any pregnant woman with severe hypertension and already established fetal complications, such as: intrauterine growth restriction, or intrauterine fetal death. f) All pregnant women with other co-morbidities such as; asthma, cardiac disease, diabetes mellitus, and other medical disorders in pregnancy. g) Any pregnant woman with prior adverse drug reaction to hydralazine and nifedipine. h) Any pregnant woman with a history of use of any antihypertensive medication within 12 hours of recruitment. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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
No 27/05/2019 NAUTH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
49 NNEWI ONITSHA ROAD nnewi 435001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time needed to achieve target blood pressure by both groups (nifedipine and hydralazine) In minutes within 30 minutes
Secondary Outcome • The total number of doses of antihypertensives required to achieve target blood pressure within 24 hours
Secondary Outcome • The need for crossover treatment from one to another, and the use of rescue antihypertensive within 24 hours
Secondary Outcome • Maternal side effects such as headache, nausea and vomiting, hot flushes, palpitations, tachycardia, within 24 hours
Secondary Outcome • Fetal side effects as fetal heart rate abnormalities within 24 hours
Secondary Outcome • Maternal complications such as seizures, antepartum haemorrhage, pulmonary oedema, acute kidney injury(reduced urinary output) within 24 hours
Secondary Outcome • Fetal complications : accessed with apgar score especially the fifth minute score within 24 hours
Secondary Outcome • Route of delivery: vaginal or caesarean section Within 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital 49 Nnewi Onitsha road Nnewi 435001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital 49 Nnewi Onitsha road Nnewi 435001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AYO OKWUOSA 49 NNEWI ONITSHA ROAD Nnewi 435001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CHUKWUDUBEM ONYEJIAKA 49 NNEWI ONITSHA ROAD NNEWI 435001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AYO OKWUOSA kuldelly@gmail.com +2347035578823 49 NNEWI ONITSHA ROAD
City Postal code Country Position/Affiliation
NNEWI 435001 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries OKAY IKPEZE ocikpeze@yahoo.com +2348167624145 49 NNEWI ONITSHA ROAD
City Postal code Country Position/Affiliation
NNEWI Nigeria PROFESSOR
Role Name Email Phone Street address
Scientific Enquiries GEORGE ELEJE georgel21@yahoo.com +2348068117444 49 NNEWI ONITSHA ROAD
City Postal code Country Position/Affiliation
NNEWI Nigeria CONSULTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes PROFORMA FOR DATA COLLECTION SUBJECT'S CODE NUMBER: .............. DATE--/--/-- TICK THE APPROPRIATE OPTION 1. AGE: (a) <20{ } (b) 20-24 { } (c) 25-29{ } (d) 30-34{ } (e) >or= 35{ } 2. PARITY: (a) 0 { } (b) 1-4{ } (c) >or= 5{ } 3. RELIGION: (a) Christianity { } (b) Islam { } (c) Others (specify).............. 4. MARITAL STATUS: (a) Single { } (b) Married { } (c) Separated { } d) Divorced { } (e) Widowed { } 5. HIGHEST EDUCATIONAL LEVEL: (a) No formal education { } (b) Primary { } (c) Secondary { } (d) Tertiary { } 6. GESTATIONAL AGE: (a) <28 { } (b) 28 to <34 { } (c) 34 to <37{ } (d) 37 to 42{} 7. Blood pressure at recruitment: Systolic -------mmHg Diastolic ------mmHg 8. The Effect of package A First dose- Time------ BP after first dose (after 20 minutes): systolic-------mmHg Diastolic -------mmHg Second dose - Time------ BP after second dose (after 20 minutes): systolic-------mmHg Diastolic -----mmHg Third dose- Time------ BP after third dose (after 20 minutes): systolic-------mmHg Diastolic -------mmHg 9. Was the target blood pressure reached? Yes { } No { } Note: Target blood pressure is Systolic 140-150mmHg and/or diastolic 90-100mmHg, with emphasis on diastolic blood pressure If the answer to No. 9 is NO, then fill No. 10 10. The effect of package B First dose- Time------- BP after first dose (after 20 minutes): systolic-------mmHg Diastolic ------mmHg Second dose - Time------- BP after second dose (after 20 minutes): systolic-------mmHg Diastolic ---mmHg Third dose- Time------ BP after third dose (after 20 minutes): systolic-------mmHg Diastolic ------mmHg 11. Was target BP reached? Yes { } No { } If the answer to No. 11 is NO, then fill No. 12 12.Which antihypertensive was used to control the blood pressure?............................................ COMPLICATIONS AND SIDE EFFECTS Informed Consent Form JULY 2019 TO DECEMBER 2019 OPEN
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