PreeclampsiaNCT07842783
Norepinephrine Infusion vs Bolus vs Ephedrine for Blood Pressure Stability During Cesarean Delivery in Women With Preeclampsia
A study testing Norepinephrine (0.05 μg/kg/min), Norepinephrine 4mcg and Ephedrine Bolus 6 mg in people with Preeclampsia and Cesarean Birth, run by Benha University at 1 site in Egypt.
Trial summary
This randomized controlled trial will compare norepinephrine infusion, norepinephrine bolus, and ephedrine bolus for maintaining hemodynamic stability during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Cesarean Birth, Hypotension During Surgery
- What is being tested?
- Norepinephrine (0.05 μg/kg/min), Norepinephrine 4mcg and Ephedrine Bolus 6 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2025to 18 Jul 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women older than 18 years of age with preeclampsia. American Society of Anesthesiologists (ASA) physical status II-III. Preeclampsia defined by systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg on two measurements at least 4 hours apart in a previously normotensive woman, accompanied by proteinuria (≥300 mg/24 hours or equivalent) or evidence of end-organ dysfunction, such as thrombocytopenia, renal or hepatic impairment, pulmonary edema, or neurological symptoms.
- Singleton pregnancy. Gestational age ≥37 weeks. Scheduled cesarean delivery under spinal anesthesia.
Who cannot join
- Refusal to participate in the study. Chronic hypertension or chronic hypertension with preeclampsia. Comorbid conditions, including diabetes mellitus or cardiovascular disease. Suspected fetal compromise. Emergency cesarean section.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norepinephrine Infusion Versus Bolus for Sustained Hemodynamic Stability in Preeclamptic Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial
This randomized controlled trial will compare norepinephrine infusion, norepinephrine bolus, and ephedrine bolus for maintaining hemodynamic stability during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Eighty-four eligible women will be randomly allocated in a 1:1:1 ratio to one of three treatment groups. The primary outcome is hemodynamic control during the first 20 minutes after spinal anesthesia, including the occurrence of hypotension, need for rescue vasopressors, and maintenance of blood pressure within ±20% of baseline. Secondary outcomes include severe hypotension, time to first hypotensive episode, vasopressor requirements, maternal adverse effects, fluid balance, and neonatal outcomes including Apgar scores, umbilical cord blood gases, and NICU admission.
Read the detailed description
Preeclampsia is associated with hemodynamic changes that may complicate blood pressure management during cesarean delivery under spinal anesthesia. Norepinephrine may be administered either as an infusion or intermittent boluses, while ephedrine is another commonly used vasopressor strategy. This study is designed to directly compare these approaches in women with preeclampsia undergoing scheduled cesarean delivery under spinal anesthesia.
This is a prospective, randomized controlled trial that will be conducted at Benha University Hospital. A total of 84 women with preeclampsia will be enrolled and randomly allocated in a 1:1:1 ratio to three groups. The norepinephrine infusion group will receive a prophylactic norepinephrine infusion starting at 0.05 µg/kg/min with titration to maintain systolic blood pressure at or above 80% of baseline. The norepinephrine bolus group will receive 4 µg intravenous norepinephrine boluses when systolic blood pressure falls below 80% of baseline. The ephedrine group will receive 6 mg intravenous ephedrine boluses under the same hypotension criterion. Rescue measures are specified in the study protocol for refractory hypotension.
All participants will undergo pre-anesthetic assessment and intraoperative monitoring including electrocardiography, non-invasive blood pressure monitoring, and pulse oximetry. Spinal anesthesia will be performed using hyperbaric bupivacaine with fentanyl. Hemodynamic monitoring will continue during the procedure and for 2 hours postoperatively.
The primary outcome is hemodynamic control during the first 20 minutes after spinal anesthesia, assessed by hypotension episodes, the need for additional rescue vasopressors, and maintenance of blood pressure within ±20% of baseline. Secondary outcomes include severe hypotension, hypertensive episodes, time to first hypotensive episode, total vasopressor requirements, bradycardia, tachycardia, nausea or vomiting, fluid balance, umbilical cord blood gas measurements, Apgar scores at 1 and 5 minutes, and NICU admission.
- Conditions
- Preeclampsia, Cesarean Birth, Hypotension During Surgery
- Being tested
- Norepinephrine (0.05 μg/kg/min), Norepinephrine 4mcg, Ephedrine Bolus 6 mg
- Keywords
- Spinal anesthesia, Norepinephrine, Ephedrine, cesarean section, hypotension
- Medical subject headings
- Pre-Eclampsia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine (0.05 μg/kg/min)Drug
Participants will receive a prophylactic intravenous norepinephrine infusion at 0.05 µg/kg/min, started immediately after spinal injection and titrated by ±0.02 µg/kg/min every 2 minutes to maintain systolic blood pressure at or above 80% of baseline. If hypotension persists despite two vasopressor doses or infusion adjustments, the infusion rate may be increased by 0.02-0.05 µg/kg/min according to the study rescue protocol.
Norepinephrine 4mcgDrug
Participants will receive intravenous norepinephrine 4 µg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 2 minutes as needed. If hypotension persists after two vasopressor doses, the norepinephrine bolus may be escalated to 6 µg according to the study rescue protocol.
Ephedrine Bolus 6 mgDrug
Participants will receive intravenous ephedrine 6 mg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 3 minutes as needed. If hypotension persists after two vasopressor doses, the ephedrine bolus may be escalated to 10 mg according to the study rescue protocol.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine Infusion | Experimental | Participants will receive a prophylactic intravenous norepinephrine infusion at 0.05 µg/kg/min, started immediately after spinal injection and titrated by ±0.02 µg/kg/min every 2 minutes to maintain systolic blood pressure at or above 80% of baseline. If hypotension persists despite two vasopressor doses or infusion adjustments, the infusion rate may be increased by 0.02-0.05 µg/kg/min according to the study rescue protocol. Receives: Drug: Norepinephrine (0.05 μg/kg/min) |
| Norepinephrine Bolus | Active comparator | Participants will receive intravenous norepinephrine 4 µg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 2 minutes as needed. If hypotension persists after two vasopressor doses, the norepinephrine bolus may be escalated to 6 µg according to the study rescue protocol. Receives: Drug: Norepinephrine 4mcg |
| Ephedrine Bolus | Active comparator | Participants will receive intravenous ephedrine 6 mg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 3 minutes as needed. If hypotension persists after two vasopressor doses, the ephedrine bolus may be escalated to 10 mg according to the study rescue protocol. Receives: Drug: Ephedrine Bolus 6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypotension During the First 20 Minutes After Spinal Anesthesia
The number and proportion of participants experiencing at least one episode of hypotension during the first 20 minutes after spinal anesthesia. Hypotension is defined in the study protocol as systolic blood pressure below 80% of the participant's baseline value.
Measured: From spinal anesthesia administration through 20 minutes after spinal anesthesia
Secondary outcomes (3)
the incidence of severe hypotension
severe hypotension defined as (SBP<70% baseline)
Measured: From spinal anesthesia administration and through the surgery
Need for Additional Rescue Vasopressors
The proportion of participants who require additional rescue vasopressor administration during the first 20 minutes after spinal anesthesia because of inadequate blood pressure control.
Measured: During the First 20 Minutes After Spinal Anesthesia
time to first hypotensive episode
(minutes from spinal injection)
Measured: after spinal anesthesia and throughout the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start18 Jul 2025
- Primary completion18 Jun 2026
- Study completion18 Jul 2026
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.
- More trials run by Benha 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
- Model description
- This is a prospective, randomized, three-arm, parallel-group controlled trial. Participants will be randomly allocated in a 1:1:1 ratio to receive norepinephrine infusion, norepinephrine bolus, or ephedrine bolus during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Participants remain in their assigned intervention group throughout the study, and maternal and neonatal outcomes will be compared among the three groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842783
- Sponsor's protocol ID
- Ms.11.7.2025
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing of individual participant data with other researchers has not yet been made.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Infusion Versus Bolus for Sustained Hemodynamic Stability in Preeclamptic Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07842783
- Acronym / sponsor ID
- Ms.11.7.2025
- Conditions
- Preeclampsia, Cesarean Birth, Hypotension During Surgery
- Keywords
- Spinal anesthesia, Norepinephrine, Ephedrine, cesarean section, hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 18 Jul 2026 (actual)
- First posted
- 25 Sep 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.
This randomized controlled trial will compare norepinephrine infusion, norepinephrine bolus, and ephedrine bolus for maintaining hemodynamic stability during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Eighty-four eligible women will be randomly allocated in a 1:1:1 ratio to one of three treatment groups. The primary outcome is hemodynamic control during the first 20 minutes after spinal anesthesia, including the occurrence of hypotension, need for rescue vasopressors, and maintenance of blood pressure within ±20% of baseline. Secondary outcomes include severe hypotension, time to first hypotensive episode, vasopressor requirements, maternal adverse effects, fluid balance, and neonatal outcomes including Apgar scores, umbilical cord blood gases, and NICU admission.
Detailed description
Preeclampsia is associated with hemodynamic changes that may complicate blood pressure management during cesarean delivery under spinal anesthesia. Norepinephrine may be administered either as an infusion or intermittent boluses, while ephedrine is another commonly used vasopressor strategy. This study is designed to directly compare these approaches in women with preeclampsia undergoing scheduled cesarean delivery under spinal anesthesia.
This is a prospective, randomized controlled trial that will be conducted at Benha University Hospital. A total of 84 women with preeclampsia will be enrolled and randomly allocated in a 1:1:1 ratio to three groups. The norepinephrine infusion group will receive a prophylactic norepinephrine infusion starting at 0.05 µg/kg/min with titration to maintain systolic blood pressure at or above 80% of baseline. The norepinephrine bolus group will receive 4 µg intravenous norepinephrine boluses when systolic blood pressure falls below 80% of baseline. The ephedrine group will receive 6 mg intravenous ephedrine boluses under the same hypotension criterion. Rescue measures are specified in the study protocol for refractory hypotension.
All participants will undergo pre-anesthetic assessment and intraoperative monitoring including electrocardiography, non-invasive blood pressure monitoring, and pulse oximetry. Spinal anesthesia will be performed using hyperbaric bupivacaine with fentanyl. Hemodynamic monitoring will continue during the procedure and for 2 hours postoperatively.
The primary outcome is hemodynamic control during the first 20 minutes after spinal anesthesia, assessed by hypotension episodes, the need for additional rescue vasopressors, and maintenance of blood pressure within ±20% of baseline. Secondary outcomes include severe hypotension, hypertensive episodes, time to first hypotensive episode, total vasopressor requirements, bradycardia, tachycardia, nausea or vomiting, fluid balance, umbilical cord blood gas measurements, Apgar scores at 1 and 5 minutes, and NICU admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a prospective, randomized, three-arm, parallel-group controlled trial. Participants will be randomly allocated in a 1:1:1 ratio to receive norepinephrine infusion, norepinephrine bolus, or ephedrine bolus during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Participants remain in their assigned intervention group throughout the study, and maternal and neonatal outcomes will be compared among the three groups.
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine Infusion | Experimental | Drug: Norepinephrine (0.05 μg/kg/min)Participants will receive a prophylactic intravenous norepinephrine infusion at 0.05 µg/kg/min, started immediately after spinal injection and titrated by ±0.02 µg/kg/min every 2 minutes to maintain systolic blood pressure at or above 80% of baseline. If hypotension persists despite two vasopressor doses or infusion adjustments, the infusion rate may be increased by 0.02-0.05 µg/kg/min according to the study rescue protocol. |
| Norepinephrine Bolus | Active comparator | Drug: Norepinephrine 4mcgParticipants will receive intravenous norepinephrine 4 µg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 2 minutes as needed. If hypotension persists after two vasopressor doses, the norepinephrine bolus may be escalated to 6 µg according to the study rescue protocol. |
| Ephedrine Bolus | Active comparator | Drug: Ephedrine Bolus 6 mgParticipants will receive intravenous ephedrine 6 mg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 3 minutes as needed. If hypotension persists after two vasopressor doses, the ephedrine bolus may be escalated to 10 mg according to the study rescue protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women older than 18 years of age with preeclampsia. American Society of Anesthesiologists (ASA) physical status II-III. Preeclampsia defined by systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg on two measurements at least 4 hours apart in a previously normotensive woman, accompanied by proteinuria (≥300 mg/24 hours or equivalent) or evidence of end-organ dysfunction, such as thrombocytopenia, renal or hepatic impairment, pulmonary edema, or neurological symptoms.
- Singleton pregnancy. Gestational age ≥37 weeks. Scheduled cesarean delivery under spinal anesthesia.
Key exclusion criteria (1 listed)
- Refusal to participate in the study. Chronic hypertension or chronic hypertension with preeclampsia. Comorbid conditions, including diabetes mellitus or cardiovascular disease. Suspected fetal compromise. Emergency cesarean section.
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 |
|---|---|---|
| Norepinephrine (0.05 μg/kg/min)Participants will receive a prophylactic intravenous norepinephrine infusion at 0.05 µg/kg/min, started immediately after spinal injection and titrated by ±0.02 µg/kg/min every 2 minutes to maintain systolic blood pressure at or above 80% of baseline. If hypotension persists despite two vasopressor doses or infusion adjustments, the infusion rate may be increased by 0.02-0.05 µg/kg/min according to the study rescue protocol. | Drug | Norepinephrine Infusion |
| Norepinephrine 4mcgParticipants will receive intravenous norepinephrine 4 µg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 2 minutes as needed. If hypotension persists after two vasopressor doses, the norepinephrine bolus may be escalated to 6 µg according to the study rescue protocol. | Drug | Norepinephrine Bolus |
| Ephedrine Bolus 6 mgParticipants will receive intravenous ephedrine 6 mg as a bolus when systolic blood pressure falls below 80% of baseline, repeated every 3 minutes as needed. If hypotension persists after two vasopressor doses, the ephedrine bolus may be escalated to 10 mg according to the study rescue protocol. | Drug | Ephedrine Bolus |
Primary outcome
Incidence of Hypotension During the First 20 Minutes After Spinal Anesthesia
Time frame: From spinal anesthesia administration through 20 minutes after spinal anesthesia
The number and proportion of participants experiencing at least one episode of hypotension during the first 20 minutes after spinal anesthesia. Hypotension is defined in the study protocol as systolic blood pressure below 80% of the participant's baseline value.
3 secondary outcomes
the incidence of severe hypotension
Time frame: From spinal anesthesia administration and through the surgery
Need for Additional Rescue Vasopressors
Time frame: During the First 20 Minutes After Spinal Anesthesia
time to first hypotensive episode
Time frame: after spinal anesthesia and throughout the surgery
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 30 Sep 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing of individual participant data with other researchers has not yet been made.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine (0.05 μg/kg/min), Norepinephrine 4mcg and Ephedrine Bolus 6 mg in people with Preeclampsia and Cesarean Birth, run by Benha University at 1 site in Egypt.
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 1 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 30 Sep 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 Egypt. 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?
Incidence of Hypotension During the First 20 Minutes After Spinal Anesthesia (time frame: From spinal anesthesia administration through 20 minutes after spinal anesthesia). 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 30 Sep 2026.