Hypertension, Pregnancy Induced | Randomized Clinical Trial of Labetalol Versus Hydralazine for Severe Hypertension in Obstetric Patients.
Hypertension, Pregnancy Induced research study
What is the primary objective of this study?
Who is eligible to participate?
Inclusion Criteria: INCLUSIONS CRITERIA Pregnant or post partum patients with systolic blood pressure ≥160mm of Hg or diastolic BP ≥110 mm Hg, on repeat measurement of blood pressure after 15 minutes of rest, meeting following inclusion criteria will be included. 1. Pregnancy greater than 28 wks(gestational age determined by ultrasound prior to 20 weeks which if unavailable then by uterine size at first prenatal visit or by last menstrual period) with gestational hypertension, severe preeclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, eclampsia and unclassified hypertension. 2. Postpartum patients, upto 72 hours after delivery, diagnosed as gestational hypertension, severe preeclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, eclampsia and unclassified hypertension. 3. Patients with singleton or multiple pregnancy. 4. Patients of all ages and parity. Exclusion Criteria: 1. Patients with asthma. 2. Patients with cardiac failure and heart block. 3. Patients with pacing device in place or any type of cardiac arrhythmia. -
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Hypertension, Pregnancy Induced
Hydralazine Adverse Reaction
Pre-eclampsia Superimposed Pre-existing Hypertension
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:LabetalolGroup A( Labetalol) will be receive intravenous labetalol bolus doses as specified in protocol summary.
Drug:HydralazineGroup B(Hydralazine) will serve as control and will receive active comparator Hydralazine intravenous bolus doses as specified in summary.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
LabetalolThis group (Group A; Labetalol) will receive intravenous(IV) labetalol manufactured by Zafa pharmaceutical, 50mg/10 ml ampoule) bolus doses administered over 2 minutes, at 10 minutes interval. Initially dose of 20mg will be administered, and if required repeated in increments of 40 mg,80 mg,80mg,80mg every 10 minutes till SBP becomes <160 and DBP <110 mm Hg, upto a maximum total dose of 300mg(total 5 bolus doses).During this time pulse and blood pressure will be checked every 10 minutes.
HydralazineThis group (Hydralazine;Group B) will receive intravenous Hydralazine and will serve as control. Bolus doses of 5 mg administered over 2 minutes, at 20 minutes interval. Pulse and blood pressure will be checked every 10 minutes interval. If SBP threshold of 160 mm Hg or DBP 110 mm Hg is still reached after 20 minutes, then second bolus will be repeated. Similarly if after 20 minutes SBP is still ≥160 or DBP ≥110 mm Hg, then third dose will be given. If SBP or DBP thresholds are still exceeded after 20 minutes then similarly 4th dose of 5 mg will be given. Failure to reduce SBP<160 or DBP<110 after consecutive maximum 4 boluses(total 20 mg) will be labeled as severe persistent hypertension.
Start Date: February 2013
Completed Date: March 2014
Phase: Phase 2/Phase 3
Primary Outcome: Sever persistent hypertension
Secondary Outcome: Maternal tachycardia
Study sponsors, principal investigator, and references
Principal Investigator: Saima A Siddiqui, MCPS,FCPS
Lead Sponsor: Dow University of Health Sciences