Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

Phase 2

• Conditions: Severe Pre-Eclampsia, Antepartum
• Interventions: Drug: Nifedipine 10 mg; Drug: Labetalol

• Registration Number: NCT03325348
• Lead Sponsor: Services Institute of Medical Sciences, Pakistan

Brief Summary

OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients

Design: Randomised control trial

SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences. Lahore

POPULATION: Pregnant patients with BP 160/110 or symptoms of severe preeclampsia

METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful

Detailed Description

Gestational hypertension is associated with increased risk of maternal morbidity and mortality. Parenteral therapy needs more resources, more monitoring and supervision. Oral therapy is cheap, easily available, easy to administer especially in resource constrained settings

OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients

Design: Randomised control trial SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences.Lahore POPULATION: Pregnant patients with BP 160/110 mm Hg or symptoms of severe preeclampsia

METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful

Study Timeline

• Study Start: 2017-02-23
• Study First Submitted: 2017-09-30
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Study First Posted: 2017-10-30
• Last Update Posted: 2017-10-30
• Primary Completion: 2017-12
• Study Completion: 2018-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 194

Inclusion Criteria

• Gestational age 24 to 41 weeks
• BP > 160/110 mm Hg with proteinuria
• Patients with S/S of imminent eclampsia as headache, visual disturbance.

Exclusion Criteria

• Gestational age < 24 wks
• Non proteinuric chronic hypertension
• Eclampsia
• Cardiac patients, asthma, severe renal disease, allergy to Nifedipine or Labetalol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Nifedipine	Nifedipine 10 mg	Nifedipine 10mg oral tablet \& 1ml 0.9%N/Saline will be given every 15 minutes up till one hour
IV Labetalol	Labetalol	IV labetalol 20 mg and mint tablet will be given every 15 minutes up till one hour

Primary Outcome Measures

Name	Time	Method
Time taken for Blood Pressure control	60 minutes	Time taken to control Blood pressure will be measured

Secondary Outcome Measures

Name	Time	Method
Neonatal Intensive Care Unit admission,	From Birth till 7 days	If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours
Fetal distress	Labour	Fetal distress will be measured by abnormalities of fetal heart rate of fetus or passage of meconium.; of Meconium
perinatal death	From birth to 7 days	If death of baby occurs in utero or within 7 days of delivery

Trial Locations

Locations (1)

Services Institute of Medical Sciences; 🇵🇰 Lahore, Punjab, Pakistan