| CTRI Number |
CTRI/2025/10/095943 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving pregnancy outcomes by treating severe high blood pressure using Iv Labetalol and Iv Hydralazine |
|
Scientific Title of Study
|
A comparative study of Intravenous Labetalol and Intravenous Hydralazine for management of Severe hypertension in Pregnancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SOUMYA DANDIN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
BLDE(DU) Shri B M Patil Medical College, Hospital, and Research Institute , Vijayapura |
| Address |
OBG OPD 2
DEPARTMENT OF OBGY
BLDE(DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SOLAPUR ROAD
VIJAYAPURA 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
8073615445 |
| Fax |
|
| Email |
soumyadandin11092000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJASRI G YALIWAL |
| Designation |
PROFESSOR, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |
| Affiliation |
BLDE(DU) Shri B M Patil Medical College, Hospital, and Research Institute , Vijayapura |
| Address |
OBG OPD 2
BLDE(DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SOLAPUR ROAD
VIJAYAPURA 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJASRI G YALIWAL |
| Designation |
PROFESSOR, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |
| Affiliation |
Shri B M Patil Medical College, Hospital, and Research Institute , Vijayapura |
| Address |
OBG OPD 2
LADIES HOSTEL
BANGARAMMA SAJJAN CAMPUS
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SOLAPUR ROAD
VIJAYAPURA , 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| BLDE(DU) Shri B M Patil Medical College, Hospital, and Research Institute , Solapur Road , Vijayapura, Karnataka , 586103 |
|
|
Primary Sponsor
|
| Name |
DR SOUMYA DANDIN |
| Address |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,
BANGARAMMA SAJJAN CAMPUS,
ASHRAM ROAD
VIJAYAPURA |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SOUMYA DANDIN |
BLDE(DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA |
OBG OPD NO 2
BANGARAMMA SAJJAN CAMPUS SOLAPUR ROAD
VIJAYAPURA , 586103
Bijapur
KARNATAKA |
8073615445
soumyadandin11092000@gmail.com |
| DR SOUMYA DANDIN |
BLDE(DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA |
OBG OPD 2
BANGARAMMA SAJJAN CAMPUS
SOLAPUR ROAD
VIJAYAPURA, 586103
Bijapur
KARNATAKA |
8073615445
soumyadandin11092000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O10-O16||Edema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O141||Severe pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INTRAVENOUS HYDRALAZINE |
Inj. Hydralazine 5 mg shall be administered slowly intravenously over 5 min.
(reconstitute one ampoule, draw hydralazine 20 mg [1 ml of reconstituted solution] into a 20 ml syringe. Dilute to 20 ml with sodium chloride (0.9%) to give a 1 mg/ml solution. Ensure it is mixed adequately.
Monitor vitals for 5 min, 10 min, 15 min, 20 min.
If the blood pressure does not settle, after 20 min, repeat 5 mg of Inj. hydralazine over 5 min.
Monitor vitals for 5 min, 10 min, 15 min, 20 min
Repeat the same with a maximum of 4 doses.
Monitor vitals for at 5min,10min,15min, 30 min, 1hour, 2 hours,3 hours 4hours, 5 hours and 6 hours.
The regimen can be continued or changed after 6 hours if blood pressure does not reduce or earlier.
Throughout the entire process, fetal heart rate will be monitored. If any abnormal fetal heart rate or compromised maternal condition is detected, the trial will be discontinued, and appropriate treatment shall be administered by the treating doctor. |
| Intervention |
INTRAVENOUS LABETALOL |
Subjects receive Labetalol 20 mg in 100ML NS infusion.
The blood pressure will be measured after 5 min, and if the BP is still found to be high(i.e. BP more 160/110 mm hg), Inj. Labetalol 20 mg will be administered again slowly iv over 2 minutes. after 10 min, if BP is still higher than the threshold (Above 160/110 mm hg), Inj Labetalol 40 MG shall be administered in an escalating dose of Inj. Labetalol 80 mg, with a maximum of 4 doses.
Pulse and BP to be recorded at 5 min,10 min,15 min, 30 min, 1 hour, 2 hour, 3 hour , 4 hour, 5 hour AND 6 hours
The regimen can be continued or changed after 6 hours or if blood pressure does not reduce earlier.
Throughout the entire process ,Fetal heart rate will be monitored. If any abnormal fetal heart rate or compromised maternal condition is detected, the trial will be discontinued, and appropriate treatment shall be administered by the treating doctor. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All consenting pregnant women of age more than or equal to 18 years with systolic blood pressure more than or equal to 160 mmHg or Diastolic blood pressure (DBP) more than or equal to 110 mmHg like gestational Hypertension, preeclampsia, chronic Hypertension, chronic Hypertension with superimposed preeclampsia , with gestational period above 28 weeks. |
|
| ExclusionCriteria |
| Details |
1.Multiple pregnancies
2.Women with known allergy to Hydralazine or Labetalol.
3.Women with idiopathic systemic lupus erythematosus or related diseases.
4.Women with myocardial insufficiency due to mechanical obstruction (ex-aortic or mitral stenosis or constrictive pericarditis).
5.Women with isolated right ventricular heart failure due to pulmonary Hypertension (cor pulmonale).
6.Women with dissecting aortic aneurysm.
7.Intrauterine death
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness of the two intravenous drugs, Hydralazine and Labetalol, in the management of severe Hypertension in pregnancy with respect to lowering blood pressure |
5min 10min 15min 30 min 1hr 2hr 3hr 4hr 5 hr and 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The maternal outcomes with Inj Hydralazine and Inj Labetolol with respect to heart rate, BP, any adverse outcome and need for additional antihypertensive therapy. |
5min 10min 15min 30 min 1hr 2hr 3hr 4hr 5 hr and 6 hours |
| Other adverse outcomes with respect to the drug. |
24 HRS |
|
|
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)
|
23/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [soumyadandin11092000@gmail.com].
- For how long will this data be available start date provided 15-09-2025 and end date provided 15-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to compare Inj. Labetalol with Inj. Hydralazine in Severe hypertension in pregnancy and to observe the adverse effects of these drugs in pregnant women. Group A- Receiving Inj. Labetalol and Group B - Receiving Inj. Hydralazine
Subjects received Labetalol 20 mg in 100ml NS infusion. Blood pressure will be measured after 5 min, and if either BP threshold is still found to be high (BP more than 160/110 mmHg), Inj. Labetalol 20 mg will be administered again slowly intravenously over 2 min. After 10 min, if BP is still higher than the threshold (above 160/110 mmhg), Inj. Labetalol 40 mg shall be administered in an escalating dose of Inj. Labetalol 80mg, with a maximum of 4 doses .Pulse and Bp to be recorded at 5min,10min,15min, 30 min, 1hr, 2hr, 3hr 4hr, 5hr and 6 hours .The regimen can be continued or changed after 6 hours or if blood pressure does not reduce earlier.
Hydralazine 5 mg shall be administered slowly intravenously over 5 min. Monitor vitals for 5 min, 10 min, 15 min, 20 min .If the blood pressure does not settle, after 20 min, repeat 5 mg of Inj Hydralazine over 5 min .Monitor vitals for 5 min, 10 min, 15 min, 20 min .Repeat the same with a maximum of 4 doses. Monitor vitals for at 5min,10min,15min, 30 min, 1hr, 2hr,3hr, 4hr, 5hr and 6hr.The regimen can be continued or changed after 6 hours or if blood pressure does not reduce or earlier. Throughout the entire process, fetal heart rate will be monitored. If any abnormal fetal heart rate or compromised maternal condition is detected, the trial will be discontinued, and appropriate treatment shall be administered by the treating doctor. This study is being done to find the effectiveness of the two intravenous drugs, Hydralazine and Labetalol, in the management of severe Hypertension in pregnancy with respect to lowering blood pressure, and the maternal outcomes with Inj. Hydralazine and Inj. Labetalol with respect to heart rate, BP, any adverse outcome and need for additional antihypertensive therapy. Other adverse outcomes with respect to the drug.
|