Pregnancy and Childbirth
Conditions
Interventions
Labetalol
Sponsors
Dr Casmir Madubuko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Diagnosis of preeclampsia with severe features after 20 weeks’ gestation, consistent with contemporary guideline-based diagnostic criteria.44,45 Sustained severe-range blood pressure, defined as SBP =160 mmHg and/or DBP =110 mmHg, confirmed on repeat measurement within a short interval and requiring urgent treatment.4¹,45 Gestational age =28 completed weeks, confirmed by last menstrual period and/or ultrasound dating where available. Singleton pregnancy. Age 18–44 years. Ability to provide informed consent personally (or via an ethically acceptable surrogate process where temporarily incapacitated—see Section 3.12).
Exclusion criteria
Exclusion criteria: ? Known contraindication to beta-blockade (for example, uncontrolled asthma/active bronchospasm, significant bradycardia, second/third-degree heart block without pacing, or decompensated cardiac failure), because labetalol may worsen these conditions.¹7 ? Known hypersensitivity/allergy to labetalol or hydralazine. ? Eclampsia at presentation (seizure before enrolment), since immediate stabilisation may necessitate protocol deviations and the emergency treatment pathway differs.²° ? Immediate need for delivery that precludes protocolled BP treatment assessment, such as frank placental abruption with maternal instability requiring immediate operative intervention.²° Established fetal compromise requiring immediate delivery before administration of study medication (defined by persistent pathological fetal heart rate pattern not responsive to initial intrauterine resuscitative measures). Any other clinical condition that, in the judgement of the attending obstetric team, makes participation unsafe, including inability to monitor BP appropriately or inability to follow the safety monitoring pathway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of target blood pressure control defined as reduction of BP to =150/100 mmHg following study drug administration (within the trial-defined assessment window), without persistent severe-range BP requiring immediate rescue therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve target BP control (minutes from first dose to first attainment of =150/100 mmHg). Dose requirements: number of bolus doses and/or cumulative dose required to achieve target BP. Need for rescue antihypertensive therapy after maximum study drug doses. Maternal adverse effects temporally associated with treatment (e.g., hypotension, tachycardia, headache, nausea, palpitations). Immediate neonatal outcomes: fetal distress following treatment, Apgar scores at 1 and 5 minutes, and neonatal unit admission. | — |
Countries
Nigeria
Contacts
Public ContactGeorge Eleje
Professor
Outcome results
None listed