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NCT05310929
Nitroglycerin Versus Labetalol in Acute Severe Pre-eclampsia
NA trial testing Labetalol and Glyceril trinitrate in Severe Pre-eclampsia in 200 participants. Completed in 25 March 2022.
20 March 2022
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 28 August 2019 |
| Primary completion | 20 March 2022 |
| Estimated completion | 25 March 2022 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Labetalol and Glyceril trinitrate — full drug profile →
Conditions studied
- Severe Pre-eclampsia — all drugs for Severe Pre-eclampsia →
Sponsor
Ain Shams University
Who can join
Adults 18 to 40, female only, with Severe Pre-eclampsia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Two hundred patients with severe PE were admitted prepartum to the ICU to stabilize blood pressure. They were randomly assigned to one of two groups (100 in each group): Group N received nitroglycerine intravenous infusion in a concentration of 1 mg/ml, thus 1µg/Kg/min equals to 4.8 ml/hr for an 80 Kg patient. Group L received labetalol intravenous infusion in a concentration of 10 mg/ ml, thus 50 mg/ml equals to 5 ml/hr. The starting infusion rate of the antihypertensive medication was 5 ml/hr. The infusion rate was titrated to stabilize systolic blood pressure (SBP) at 130-140 mmHg and diastolic blood pressure (DBP) at 80-90 mmHg (study end point) by adjusting the infusion rate as required either by maintaining the same infusion rate or by changing its infusion rate by 1 ml/hr up or down according to the clinical condition every 10 minutes. On any abrupt reduction in blood pressure below 120 mmHg for SBP or 80 mmHg for DBP, the infusion was immediately discontinued, and a bolus of 150 ml lactate ringer was given.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacotherapeutic options for the treatment of hypertension in pregnancy.
Conti-Ramsden F, de Marvao A, Chappell LC. · · 2024 · cited 4× · PMID 39225514 · DOI 10.1080/14656566.2024.2398602
Verify or expand the search:
- PubMed search for NCT05310929
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05310929 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 5 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05310929.
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