Severe PreeclampsiaNCT06265415
Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine
A study testing Labetalol, Nitroglycerine and Nifedipine in people with Severe Preeclampsia, run by Sohag University.
Trial summary
Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.control of blood pressure is of crucial importance to avoid maternal and fetal complications.Therapeutic modalities that can target the underlying… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Severe Preeclampsia
- What is being tested?
- Labetalol, Nitroglycerine and Nifedipine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 30 Mar 2025
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The study will include 60 adult female patients ( 18 to 40 years old) with sever pre-eclampsia, who were being managed with MgSO4 loading and maintenance doses Severe hypertension was diagnosed by Systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥110 mmHg.
- Mean arterial blood pressure ≥ 127 mmHg
Who cannot join
- Patient refusal.
- Eclampsia
- Emenant eclampsia
- HELLP syndrome
- Chronic hypertension
- Patients who have chronic obstructive pulmonary disease.
- Patient with acute or chronic liver failure.
- Known allergy to the study medications
Trial locations and contacts
No sites are listed yet.
fawzy A badawy, assistant professor contact
About this study
Official title: A Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine to Control Blood Pressure in Severe Pre-eclampsia
Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.control of blood pressure is of crucial importance to avoid maternal and fetal complications.Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE
Read the detailed description
Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.
Pre-eclampsia characterized by
- Rising blood pressure (BP ≥ 140/90 that occurs after 20 weeks of gestation in a woman with previously normal BP.
- . Proteinuria (≥300mg/24hr . This correlates with 30mg/dl or ≥1+ on urine dipstick)
- Edema control of blood pressure is of crucial importance to avoid maternal and fetal complications.
The pathophysiology of pre-eclampsia is most likely inadequate placentation, leading to endothelial dysfunction and reduced nitric oxide bioavailability. Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE
. Nitroglycerine, a nitric oxide donor with low oral bioavailability and a very short half-life, has a potent venodilator effect in low doses and affects arterial tone at high doses Labetalol is useful as it contains both selective, competitive, alpha1-adrenergic antagonism and non-selective, competitive, beta-adrenergic (B1 and B2) blocking activity in a single agent Nifedipine is a dihydropyridine calcium channel blocker. Its main uses are as an antianginal and antihypertensive
- Conditions
- Severe Preeclampsia
- Being tested
- Labetalol, Nitroglycerine, Nifedipine
- 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
it contains both selective, competitive, alpha1-adrenergic antagonism and non-selective, competitive, beta-adrenergic (B1 and B2) blocking activity in a single agent
NitroglycerineDrug
a nitric oxide donor with low oral bioavailability and a very short half-life, has a potent venodilator effect in low doses and affects arterial tone at high doses
NifedipineDrug
dihydropyridine calcium channel blocker. Its main uses are as an antianginal and antihypertensive
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | (20 patients) will receive Labetalol intravenous infusion. The starting infusion rate is 5mg/h,the infusion rate will be changed 1mg/h up every 10 minutes until the desired goal achieved which is a decrease in systolic blood pressure (SBP) to 120 - 140 mmHg and a decrease in diastolic blood pressure (DBP) to 80 - 90 mmHg every 10 minutes Receives: Drug: Labetalol |
| group B | Active comparator | (20 patients) will receive calculated dose of Nitroglycerine started as intravenous infusion, The starting infusion rate is 4.8mg/h ,the infusion rate will be changed 1mg/h every 10 minutes up until the therapeutic goal achieved, which is a decrease in systolic blood pressure (SBP) to 120 - 140 mmHg and a decrease in diastolic blood pressure (DBP) to 80 - 90 mmHg Receives: Drug: Nitroglycerine |
| group C | Active comparator | , (20 patients) will receive calculated dose of nifedipine the content (100 µL) of a 10 mg capsule of nifedipine was drawn up into an insulin syringe and deposited sublingually, every 30 min.( Maximum dose of nifedipine 120 mg/day) ) until the therapeutic goal achieved, which is a decrease in systolic blood pressure (SBP) to 120 - 140 mmHg and a decrease in diastolic blood pressure (DBP) to 80 - 90 mmHg Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of control blood pressure
duration required, of nitroglycerin compared to labetalol and sublingual nifedipine in terms of acute control of blood pressure in severe PE.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa Aly Abdelaal, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265415
- Sponsor's protocol ID
- Soh-Med-24-01-07MS
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Mulhim AA, Abu-Heija A, Al-Jamma F, El-Harith el-HA. Pre-eclampsia: maternal risk factors and perinatal outcome. Fetal Diagn Ther. 2003 Jul-Aug;18(4):275-80. doi: 10.1159/000070809.
PubMed 12835589Olayinka L, Garnett E, Burnett B, Devaraj S. Comparison of random urine protein/creatinine ratio with 24-hour urine protein in suspected pre-eclampsia. Pract Lab Med. 2023 Jun 21;36:e00316. doi: 10.1016/j.plabm.2023.e00316. eCollection 2023 Aug.
PubMed 37649542Johal T, Lees CC, Everett TR, Wilkinson IB. The nitric oxide pathway and possible therapeutic options in pre-eclampsia. Br J Clin Pharmacol. 2014 Aug;78(2):244-57. doi: 10.1111/bcp.12301.
PubMed 24313856Divakaran S, Loscalzo J. The Role of Nitroglycerin and Other Nitrogen Oxides in Cardiovascular Therapeutics. J Am Coll Cardiol. 2017 Nov 7;70(19):2393-2410. doi: 10.1016/j.jacc.2017.09.1064.
PubMed 29096811
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine to Control Blood Pressure in Severe Pre-eclampsia
- ClinicalTrials.gov ID
- NCT06265415
- Acronym / sponsor ID
- Soh-Med-24-01-07MS
- Conditions
- Severe Preeclampsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 20 Feb 2024 (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.
Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.control of blood pressure is of crucial importance to avoid maternal and fetal complications.Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE
Detailed description
Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.
Pre-eclampsia characterized by
- Rising blood pressure (BP ≥ 140/90 that occurs after 20 weeks of gestation in a woman with previously normal BP.
- . Proteinuria (≥300mg/24hr . This correlates with 30mg/dl or ≥1+ on urine dipstick)
- Edema control of blood pressure is of crucial importance to avoid maternal and fetal complications.
The pathophysiology of pre-eclampsia is most likely inadequate placentation, leading to endothelial dysfunction and reduced nitric oxide bioavailability. Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE
. Nitroglycerine, a nitric oxide donor with low oral bioavailability and a very short half-life, has a potent venodilator effect in low doses and affects arterial tone at high doses Labetalol is useful as it contains both selective, competitive, alpha1-adrenergic antagonism and non-selective, competitive, beta-adrenergic (B1 and B2) blocking activity in a single agent Nifedipine is a dihydropyridine calcium channel blocker. Its main uses are as an antianginal and antihypertensive
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Labetalol(20 patients) will receive Labetalol intravenous infusion. The starting infusion rate is 5mg/h,the infusion rate will be changed 1mg/h up every 10 minutes until the desired goal achieved which is a decrease in systolic blood pressure (SBP) to 120 - 140 mmHg and a decrease in diastolic blood pressure (DBP) to 80 - 90 mmHg every 10 minutes |
| group B | Active comparator | Drug: Nitroglycerine(20 patients) will receive calculated dose of Nitroglycerine started as intravenous infusion, The starting infusion rate is 4.8mg/h ,the infusion rate will be changed 1mg/h every 10 minutes up until the therapeutic goal achieved, which is a decrease in systolic blood pressure (SBP) to 120 - 140 mmHg and a decrease in diastolic blood pressure (DBP) to 80 - 90 mmHg |
| group C | Active comparator | Drug: Nifedipine, (20 patients) will receive calculated dose of nifedipine the content (100 µL) of a 10 mg capsule of nifedipine was drawn up into an insulin syringe and deposited sublingually, every 30 min.( Maximum dose of nifedipine 120 mg/day) ) until the therapeutic goal achieved, which is a decrease in systolic blood pressure (SBP) to 120 - 140 mmHg and a decrease in diastolic blood pressure (DBP) to 80 - 90 mmHg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The study will include 60 adult female patients ( 18 to 40 years old) with sever pre-eclampsia, who were being managed with MgSO4 loading and maintenance doses Severe hypertension was diagnosed by Systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥110 mmHg.
- Mean arterial blood pressure ≥ 127 mmHg
Key exclusion criteria (8 listed)
- Patient refusal.
- Eclampsia
- Emenant eclampsia
- HELLP syndrome
- Chronic hypertension
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 |
|---|---|---|
| Labetalolit contains both selective, competitive, alpha1-adrenergic antagonism and non-selective, competitive, beta-adrenergic (B1 and B2) blocking activity in a single agent | Drug | group A |
| Nitroglycerinea nitric oxide donor with low oral bioavailability and a very short half-life, has a potent venodilator effect in low doses and affects arterial tone at high doses | Drug | group B |
| Nifedipinedihydropyridine calcium channel blocker. Its main uses are as an antianginal and antihypertensive | Drug | group C |
Primary outcome
duration of control blood pressure
Time frame: 1 year
duration required, of nitroglycerin compared to labetalol and sublingual nifedipine in terms of acute control of blood pressure in severe PE.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 12835589Al-Mulhim AA, Abu-Heija A, Al-Jamma F, El-Harith el-HA. Pre-eclampsia: maternal risk factors and perinatal outcome. Fetal Diagn Ther. 2003 Jul-Aug;18(4):275-80. doi: 10.1159/000070809.
- Background: PubMed 37649542Olayinka L, Garnett E, Burnett B, Devaraj S. Comparison of random urine protein/creatinine ratio with 24-hour urine protein in suspected pre-eclampsia. Pract Lab Med. 2023 Jun 21;36:e00316. doi: 10.1016/j.plabm.2023.e00316. eCollection 2023 Aug.
- Background: PubMed 24313856Johal T, Lees CC, Everett TR, Wilkinson IB. The nitric oxide pathway and possible therapeutic options in pre-eclampsia. Br J Clin Pharmacol. 2014 Aug;78(2):244-57. doi: 10.1111/bcp.12301.
- Background: PubMed 29096811Divakaran S, Loscalzo J. The Role of Nitroglycerin and Other Nitrogen Oxides in Cardiovascular Therapeutics. J Am Coll Cardiol. 2017 Nov 7;70(19):2393-2410. doi: 10.1016/j.jacc.2017.09.1064.
- Individual participant dataSharing planned: Undecided
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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.
fawzy A badawy, assistant professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Labetalol, Nitroglycerine and Nifedipine in people with Severe Preeclampsia, run by Sohag University.
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 2 inclusion and 8 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 20 Feb 2024. 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.
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 diaa A abdelaal, resident (01064451169, deaaaly@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of control blood pressure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265415, which also lists 4 linked publications.
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 20 Feb 2024.