Postnatal HypertensionPhase 3NCT02426177
Comparison of Tab.Labetalol and Tab.Nifedipine for Management of Postpartum Hypertension
A Phase 3 study testing Labetalol and Nifedipine in people with Postnatal Hypertension, run by Dow University of Health Sciences.
Trial summary
To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum hypertension. Read more about this study
- Who is it for?
- Ages 20 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postnatal Hypertension
- What is being tested?
- Labetalol and Nifedipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- all women with postpartum hypertension as a continuation of pregnancy induced hypertension,eclampsia, pre-eclampsia or new onset de-novo postpartum hypertension,of any parity.
- age group between 18-48.
- after informed consent.
Who cannot join
- all women with chronic hypertension, uncontrolled and un treated medical disorders will be excluded.
- conditions in which drugs labetalol and nifedipine is contraindicated.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Oral Labetalol and Oral Nifedipine for Postpartum Hypertension Management
To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum hypertension.
Read the detailed description
A comparison of oral labetalol and oral nifedipine for management of postpartum hypertension. Which drug is more effective in lowering blood pressures in patient with postpartum hypertension.
- Conditions
- Postnatal Hypertension
- Being tested
- Labetalol, Nifedipine
- Keywords
- postpartum hypertension, labetalol in postpartum hypertension, nifedipine in postpartum hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
anti-hypertensive agents
NifedipineDrug
calcium channel blocker ,for lowering blood pressure
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | tab.labetalol is given to the patient with postpartum hypertension in dose of 100 mg 6 hourly increased to maximum 600 mg in 24 hours Receives: Drug: Labetalol |
| group B | Active comparator | tab.nifedipine is given to the patient with postpartum hypertension in the dose of 10 mg twice a day to maximum dose of 60 mg per 24 hours Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure less than 140/90 mm of hg
less than 140/90 mm of hg
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fariha javed, Dow University of Health Sciences
- Investigators
- fariha javed, mbbs, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426177
- Sponsor's protocol ID
- DowUHS
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Labetalol and Oral Nifedipine for Postpartum Hypertension Management
- ClinicalTrials.gov ID
- NCT02426177
- Acronym / sponsor ID
- DowUHS
- Conditions
- Postnatal Hypertension
- Keywords
- postpartum hypertension, labetalol in postpartum hypertension, nifedipine in postpartum hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum hypertension.
Detailed description
A comparison of oral labetalol and oral nifedipine for management of postpartum hypertension. Which drug is more effective in lowering blood pressures in patient with postpartum hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Labetaloltab.labetalol is given to the patient with postpartum hypertension in dose of 100 mg 6 hourly increased to maximum 600 mg in 24 hours |
| group B | Active comparator | Drug: Nifedipinetab.nifedipine is given to the patient with postpartum hypertension in the dose of 10 mg twice a day to maximum dose of 60 mg per 24 hours |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- all women with postpartum hypertension as a continuation of pregnancy induced hypertension,eclampsia, pre-eclampsia or new onset de-novo postpartum hypertension,of any parity.
- age group between 18-48.
- after informed consent.
Key exclusion criteria (2 listed)
- all women with chronic hypertension, uncontrolled and un treated medical disorders will be excluded.
- conditions in which drugs labetalol and nifedipine is contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labetalolanti-hypertensive agents | Drug | group A |
| Nifedipinecalcium channel blocker ,for lowering blood pressure | Drug | group B |
Primary outcome
Blood Pressure less than 140/90 mm of hg
Time frame: 24 hours
less than 140/90 mm of hg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
Related trials for Postnatal Hypertension
Not yet recruitingObservational study
Ophthalmic Artery Doppler in the Puerperium After Hypertensive Disorders of Pregnancy (OPHELIA-PP)
Hypertensive Disorders of Pregnancy, Pre-eclampsia
Recruiting
HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children
Pregnancy, Postpartum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fariha javed, mbbs principal investigator
Dow University of Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Labetalol and Nifedipine in people with Postnatal Hypertension, run by Dow University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fariha javed, mbbs (923009298708, farihajaved207@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure less than 140/90 mm of hg (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.