An interventional study of Norepinephrine (0.05 μg/kg/min) and Norepinephrine 4mcg in Preeclampsia, Cesarean Birth and Hypotension During Surgery, sponsored by Benha University. Completed at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
Among 79 studies in Pre-Eclampsia with a site in Egypt — 11 open to participants now, 12 under way, none of them phase 3. Pre-Eclampsia · Egypt.
Among the 79 studies in Pre-Eclampsia with a site in Egypt, this one is the 25th largest by enrollment of the 40 interventional ones that give a count, is one of 5 that started in 2025, is one of 21 with no phase, and was the 79th registered.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
Browse Pre-Eclampsia studies →11 of the 79 studies in Pre-Eclampsia with a site in Egypt are open now. Recruiting first, the newest first:
Cairo University · Sites in Egypt
Ages 20–40 · Women only
Tanta University · Sites in Egypt
Ages 18–40 · Women only · Healthy volunteers
South Valley University · Sites in Egypt
Ages 18–50 · Women only · Healthy volunteers
Ain Shams Maternity Hospital · Sites in Egypt
Ages 18+ · Women only
Ain Shams University · Sites in Egypt
Women only
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 6 · Phase 4 9
First in 2013; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 84 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Median enrollment 100 across the 40 interventional studies, 90 across the 39 observational. Of the 39 that completed or were terminated, 0 (0%) have results posted.
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1 of 79 have an industry lead sponsor. The 10 most frequent:
Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
Benha University has 5 studies filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
2 of the studies in Pre-Eclampsia with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07423741South Valley UniversityUltrasonographical Assessment of Airway Indices in Pregnancy | 2026-11 |
| NCT07443345Cairo UniversityIncidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia | 2026-12-30 |
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Among the 79 studies in Pre-Eclampsia with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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Women older than 18 years of age with preeclampsia. (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.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 (0.05 μg/kg/min)
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.
Drug: Norepinephrine 4mcg
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.
Drug: Ephedrine Bolus 6 mg
Drug page: Norepinephrine
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.
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.
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.
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.
Time frame: From spinal anesthesia administration through 20 minutes after spinal anesthesia
the incidence of severe hypotension
severe hypotension defined as (SBP\<70% baseline)
Time frame: 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.
Time frame: During the First 20 Minutes After Spinal Anesthesia
time to first hypotensive episode
(minutes from spinal injection)
Time frame: after spinal anesthesia and throughout the surgery
Plan to share: Undecided — A decision regarding sharing of individual participant data with other researchers has not yet been made.
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Jun 2026, 11 months.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 11 months is below that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Norepinephrine