Randomized Controlled Trial of Labetalol Versus Hydralazine for Severe Hypertension in Obstetric Patients.
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
Severe Hypertension in pregnancy demands urgent treatment because of high mortality &
morbidity in obstetric patients. Hydralazine, the most commonly used agent, causes sudden
hypo tension and tachycardia. Labetalol because of combined α and β blocking effects lacks
these side effects. Most recent Cochrane systematic review on use of anti hypertensive drugs
in pregnancy related hypertension, could include only four trials of comparison of
Hydralazine with Labetalol. Three out of total 4, had sample size ranging from 20-60
obstetric, with total sample size ranging from 19-30. Only 2 trials reported severe
persistent hypertension.This review could not conclude about comparative effects due to
insufficient data and suggested that further trials should compare Hydralazine with
Nifedipine or labetalol, and to report severe persistent hypertension and adverse
feto-maternal effects.
OBJECTIVES:1) To compare efficacy and severe persistent hypertension after intravenous
Labetalol versus Hydralazine, within maximum 5 drug boluses, in obstetric severe hypertensive
patients at Civil Hospital Karachi.
2) To compare immediate adverse maternal and fetal effects in the study group. 3)
Furthermore, to assess response to treatment, in terms of patient and disease
characteristics.
STUDY DESIGN: Randomized controlled trial.
SETTING & DURATION OF STUDY: Gynaecology Unit I, Civil hospital Karachi, from Oct 2012 to Sep
2014
METHODS: Total one hundred eighty-four patients with, severe hypertension (systolic blood
pressure(S.B.P)≥160 and/or diastolic blood pressure(D.B.P) ≥110 mm Hg) at greater than 28
weeks of pregnancy or upto 72 hours after delivery, were enrolled and randomly allocated to
drug A or B. At enrollment, 94 patients were allocated to Labetalol to 96 to Hydralazine
through simple randomization. Since six cases were excluded due to insufficient information(
2 from group A and 4 from group B) so finally data of 92 patients in each group was analyzed.
Primary outcome measures were lowering of S.B.P to <160 mm Hg and D.B.P <110 mm Hg
(efficacy)and severe persistent hypertension. In addition maternal hypo tension, tachycardia,
bradycardia, adverse effect on fetal heart, still birth and neonatal bradycardia were
measured.
EXPECTED OUTCOME: Efficacy, severe persistent hypertension and side effects of Labetalol
versus Hydralazine, in our population were determined.
Assessment of response to Drug A and B, will help in choosing a drug for different patient
and disease characteristics.