| CTRI Number |
CTRI/2025/03/082731 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study between oral Labetalol and oral Nifedipine in gestational hypertension |
|
Scientific Title of Study
|
A comparative study between oral Labetalol and oral Nifedipine in pregnancy induced hypertension |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swagata Dey |
| Designation |
Post Graduate trainee |
| Affiliation |
Tezpur Medical College and hospital |
| Address |
Tezpur Medical college and hospital , Department of Obstetrics and Gynaecology, OBGY Division, Room No. 49
P.O. and Dist- Sonitpur, Assam
PIN- 784010
Sonitpur
ASSAM
784010
India |
| Phone |
8486124421 |
| Fax |
|
| Email |
swagata98dey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purashree Sarma |
| Designation |
Assistant Professor |
| Affiliation |
Tezpur Medical College and Hospital |
| Address |
Tezpur Medical college and hospital , Department of Obstetrics and Gynaecology, OBGY Division, Room No. 49
P.O. and Dist- Sonitpur, Assam
PIN- 784010
Sonitpur
ASSAM
784010
India |
| Phone |
9101588288 |
| Fax |
|
| Email |
purashreesarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purashree Sarma |
| Designation |
Assistant Professor |
| Affiliation |
Tezpur Medical College and Hospital |
| Address |
Tezpur Medical college and hospital, Department of Obstetrics and Gynaecology, OBGY Division, Room No. 49
P.O. and Dist- Sonitpur, Assam
PIN- 784010
Sonitpur
ASSAM
784010
India |
| Phone |
9101588288 |
| Fax |
|
| Email |
purashreesarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tezpur Medical College and Hospital, Department of Obstetrics and Gynaecology, OBGY Division, Room No. 49, P.O. and Dist- Sonitpur, Assam, PIN- 784010, iNDIA |
|
|
Primary Sponsor
|
| Name |
Swagata Dey |
| Address |
Tezpur Medical College and Hospital, Department of Obstetrics and Gynaecology, OBGY Division, Room No. 49, P.O. and Dist- Sonitpur, Assam, PIN- 784010, iNDIA |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Swagata Dey |
TEZPUR MEDICAL COLLEGE AND HOSPITAL, ASSAM |
Department of Obstetrics and Gynaecology, Obstetrics and Gynaecology Division,Room No. 49, Sonitpur
Sonitpur
ASSAM |
8486124421
swagata98dey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETCHICAL COMMITTEE TEZPUR MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O134||Gestational [pregnancy-induced] hypertension without significant proteinuria, complicating childbirth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Nifedipine |
tab Nifedipine 10mg OD for 3 days |
| Intervention |
Tab Labetalol |
Tab labetalol 100mg OD for 3 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women more than 20 weeks of gestation with
blood pressure reading ≥140/90 mmHg and medical
decision to control blood pressure rapidly were included
for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients who do not consent for participation in the study
2. Patients with chronic hypertension i.e. known cases of hypertension or hypertension diagnosed first time in pregnancy but before 20 weeks of gestational age.
3. Women with a history of heart rhythm abnormality, heart failure, asthma, allergy to either of the drugs, non-pregnancy related hypertension are to be excluded from the study.
4. Patients receiving any other antihypertensive drug preceding 72 hours of admission will also be excluded from study.
5. History of Smoking
6. Any chronic medical illness with pre existing renal disease, liver disease
7. Patients who are not willing to give consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time (minutes) taken to achieve blood pressure
≤140/90 mmHg
Total antihypertensive doses to achieve blood pressure
≤140/90 mmHg |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mode of delivery
Baby weight
Neonatal complications
Maternal complications
Apgar score at 5 min
Neonatal status |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Pregnancy-induced hypertension, also called gestational hypertension, is high blood pressure that develops after 20 weeks of pregnancy and resolves after childbirth. Labetalol works by blocking both alpha-1 and beta-adrenergic receptors, which leads to reduced vascular resistance and heart rate, thereby lowering blood pressure. Nifedipine works by relaxing blood vessels, which reduces vascular resistance and lowers blood pressure. In this study we try to understand the efficacy of both the drugs. |