PreeclampsiaNCT07572656
Comparison of Intravenous Labetalol and Intravenous Hydralazine in Severe Preeclampsia
A study testing Labetalol and Hydralazine in people with Preeclampsia, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Due to limited data regarding preeclampsia from the local population, the debate is still ongoing in the study setting. Hence, the current study was planned to compare the efficacy of labetalol and hydralazine for the treatment of hypertension in patients with severe preeclampsia. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Labetalol and Hydralazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 31 Oct 2024
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women
- Both primiparous and multiparous women
- Aged 20-35 years
- Gestational age ≥20weeks (assessed on last menstrual period)
- With severe preeclampsia
Who cannot join
- Known allergy to hydralazine or labetalol
- Deranged liver function tests due to any other cause
- Women with pre-existing hypertension systolic blood pressure ≥130 mmHg, diastolic blood pressure ≥80 mmHg
- Patients receiving more than one antihypertensive drug since admission
- Women with chronic renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Intravenous Labetalol and Intravenous Hydralazine for the Treatment of Hypertension in Patients With Severe Preeclampsia.
Due to limited data regarding preeclampsia from the local population, the debate is still ongoing in the study setting. Hence, the current study was planned to compare the efficacy of labetalol and hydralazine for the treatment of hypertension in patients with severe preeclampsia.
Read the detailed description
As preeclampsia is associated with high perinatal mortality and morbidity, the choice of a better antihypertensive in pregnancy is still debatable. The findings of this study would help evaluate the more efficacious drug between intravenous labetalol and intravenous hydralazine in the management of severe preeclampsia. Based on this empirical evidence, practical recommendations can be developed for routine practice guidelines regarding the optimal drug choice between the two for treating severe preeclampsia and eventually to reduce perinatal mortality and morbidity for both the mother and fetus.
- Conditions
- Preeclampsia
- Being tested
- Labetalol, Hydralazine
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
Patients were given a 20 mg bolus dose of labetalol in 2 minutes, and blood pressure was checked after 20 minutes; if not effective, then a 40 mg dose of labetalol was given. If still no effect was seen, then 80 mg was given every 20 minutes up to a maximum dose of 300 mg, and every time blood pressure was checked after 20 minutes.
HydralazineDrug
Patients were given intravenous hydralazine, 5 mg in a bolus dose, then repeated every 20 minutes as needed up to five doses; a maximum of 25 mg was given.
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Experimental | Patients were given a 20 mg bolus dose of labetalol in 2 minutes, and blood pressure was checked after 20 minutes; if not effective, then a 40 mg dose of labetalol was given. If still no effect was seen, then 80 mg was given every 20 minutes up to a maximum dose of 300 mg, and every time blood pressure was checked after 20 minutes. Receives: Drug: Labetalol |
| Group-B | Experimental | Patients were given intravenous hydralazine, 5 mg in a bolus dose, then repeated every 20 minutes as needed up to five doses; a maximum of 25 mg was given. Receives: Drug: Hydralazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
The efficacy was labeled as 'yes' if a blood pressure of 140/90 was achieved, frequency of patients was noted.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 May 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Namra Rasheed, Principal investigator, Sadiq Abbasi Hospital, Bahawalpur, PakistanSaba Nadeem, FCPS, Study director, Sadiq Abbasi Hospital, Bahawalpur, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572656
- Sponsor's protocol ID
- Dr-Namra-QAMC
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Intravenous Labetalol and Intravenous Hydralazine for the Treatment of Hypertension in Patients With Severe Preeclampsia.
- ClinicalTrials.gov ID
- NCT07572656
- Acronym / sponsor ID
- Dr-Namra-QAMC
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 7 May 2026 (actual)
- 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.
Due to limited data regarding preeclampsia from the local population, the debate is still ongoing in the study setting. Hence, the current study was planned to compare the efficacy of labetalol and hydralazine for the treatment of hypertension in patients with severe preeclampsia.
Detailed description
As preeclampsia is associated with high perinatal mortality and morbidity, the choice of a better antihypertensive in pregnancy is still debatable. The findings of this study would help evaluate the more efficacious drug between intravenous labetalol and intravenous hydralazine in the management of severe preeclampsia. Based on this empirical evidence, practical recommendations can be developed for routine practice guidelines regarding the optimal drug choice between the two for treating severe preeclampsia and eventually to reduce perinatal mortality and morbidity for both the mother and fetus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A | Experimental | Drug: LabetalolPatients were given a 20 mg bolus dose of labetalol in 2 minutes, and blood pressure was checked after 20 minutes; if not effective, then a 40 mg dose of labetalol was given. If still no effect was seen, then 80 mg was given every 20 minutes up to a maximum dose of 300 mg, and every time blood pressure was checked after 20 minutes. |
| Group-B | Experimental | Drug: HydralazinePatients were given intravenous hydralazine, 5 mg in a bolus dose, then repeated every 20 minutes as needed up to five doses; a maximum of 25 mg was given. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women
- Both primiparous and multiparous women
- Aged 20-35 years
- Gestational age ≥20weeks (assessed on last menstrual period)
- With severe preeclampsia
Key exclusion criteria (5 listed)
- Known allergy to hydralazine or labetalol
- Deranged liver function tests due to any other cause
- Women with pre-existing hypertension systolic blood pressure ≥130 mmHg, diastolic blood pressure ≥80 mmHg
- Patients receiving more than one antihypertensive drug since admission
- Women with chronic renal failure
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 |
|---|---|---|
| LabetalolPatients were given a 20 mg bolus dose of labetalol in 2 minutes, and blood pressure was checked after 20 minutes; if not effective, then a 40 mg dose of labetalol was given. If still no effect was seen, then 80 mg was given every 20 minutes up to a maximum dose of 300 mg, and every time blood pressure was checked after 20 minutes. | Drug | Group-A |
| HydralazinePatients were given intravenous hydralazine, 5 mg in a bolus dose, then repeated every 20 minutes as needed up to five doses; a maximum of 25 mg was given. | Drug | Group-B |
Primary outcome
Treatment efficacy
Time frame: 6 hours
The efficacy was labeled as 'yes' if a blood pressure of 140/90 was achieved, frequency of patients was noted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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Severe Preeclampsia
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.
Namra Rasheed principal investigator
Sadiq Abbasi Hospital, Bahawalpur, Pakistan
Saba Nadeem, FCPS study director
Sadiq Abbasi Hospital, Bahawalpur, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labetalol and Hydralazine in people with Preeclampsia, run by Muhammad Aamir Latif at 1 site in Pakistan.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: 6 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 7 May 2026.