| CTRI Number |
CTRI/2014/12/005285 [Registered on: 12/12/2014] Trial Registered Prospectively |
| Last Modified On: |
16/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare two different drugs for acute blood pressure control during pregnancy |
|
Scientific Title of Study
|
A randomized trial to compare the effectiveness of oral nifedipine & intra-venous Hydralazine in acute hypertensive emergencies of pregnancy |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chanderdeep Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr RPGMC Kangra |
| Address |
Dr Rajendra Prasad Government Medical College Kangra at Tanda (HP)
Tanda at Kangra (HP)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9218925471 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chanderdeep Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr RPGMC Kangra |
| Address |
Dr Rajendra Prasad Government Medical College Kangra at Tanda (HP)
Tanda at Kangra (HP)
HIMACHAL PRADESH
176001
India |
| Phone |
9218925471 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chanderdeep Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr RPGMC Kangra |
| Address |
Dr Rajendra Prasad Government Medical College Kangra at Tanda (HP)
Tanda at Kangra (HP)
HIMACHAL PRADESH
176001
India |
| Phone |
9218925471 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Government of Himachal Pradesh |
| Address |
Dr Rajendra Prasad Government Medical College Kangra at Tanda (HP) |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chanderdeep Sharma |
Dr R.P. Govt. Medical; College Kangra at Tanda (HP) |
Labor ward, Deptt. of Obstetrics & Gynecology
Kangra
HIMACHAL PRADESH |
9218925471
cdsharma2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr RP Govt. Mediacl College, Kangra at Tanda (HP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pregnant women with hypertensive emergencies (BP more than 160 and or 110 mm of Hg at more than 24 weeks pregnancy), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydralazine |
• Hydralazine: Intravenous hydralazine will be administered every 20 minutes with till the target BP (150 mm of Hg & diastolic 100 mm of Hg) is achieved in consecutive doses of i.e. 5 mg, 10 mg, 10 mg, and 10 mg, to a maximum of four doses. If still after four doses target BP is not achieved cross over to opposite regimen will be done.Such therapy will be followed till target BP (SBP150 & DBP100 mm of Hg) is obtained. |
| Comparator Agent |
Nifedipine |
Tablet nifedipine 10 mg to be repeated every 20 minutes till target BP is achieved (systolic 150 mm of Hg & diastolic 100 mm of Hg) to maximum four doses. If still after four doses target BP is not achieved cross over to opposite regimen will be done.Such therapy will be followed till target BP (SBP150 & DBP100 mm of Hg) is obtained. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between 18 to 45 years,
2. Period of gestation > 24 weeks of gestation
3. Maternal Heart rate; 60-90 beats per minute
4. Reassuring fetal heart rate.
|
|
| ExclusionCriteria |
| Details |
1. known case of heart disease (pre-existing angina)
2. Non-pregnancy related hypertension (diagnosed cases of chronic or secondary hypertension)
3. Allergy to either of the drug
4. Need for any acute emergency for cesarean section (Abruptio placentae, severe fetal bradycardia etc)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time required to achieve target systolic BP of 150 mm of Hg or lower and diastolic BP of 100 mm of Hg or lower (both targets had to be fulfilled). |
2 hours after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
 Total number of antihypertensive dosages required to achieve the target BP (systolic BP of 150 mm of Hg or lower and diastolic BP of 100 mm of Hg or lower, both to be fulfilled)
 Maternal heart rate profile during the study period
 Maternal hypotension (BP less than 90/60 mm Hg)
 Side effects profile (Nausea, Vomiting, Headache, dizziness, urticaria, flushing, pruritis, nasal congestion, conjunctivitis, palpitations)
 Perinatal outcome
|
2 hours after delivery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Sharma C, Soni A, Gupta A, et al. Hydralazine vs nifedipine for acute hypertensive emergency in pregnancy: a randomized controlled trial. Am J Obstet Gynecol 2017; ARTICLE IN PRESS. doi.org/10.1016/j.ajog.2017.08.018 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this double blind randomized controlled trial sixty women (thirty in each group), with acute hypertensive emergency of pregnancy (defined as BP more than 160 systolic and or more than 110 diastolic) at more than 24 weeks of gestation, will be randomized to either receive intravenous hydralazine (dose 5 mg, 10 mg, 10 mg, 10 mg, repeated every 20 minutes to maximum 4 doses)or oral nifedipine (dose 10 mg each repeated after 20 minutes each to maximum of 4 doses) every 20 minutes till target BP is achieved (less than 150 systolic and 100 diastolic), after satisfying inclusion and exclusion criteria. Time required to achieve target BP, side effect profile and perinatal outcome will be observed in each woman. |