Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

Services Institute of Medical Sciences, Pakistan

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Severe Pre-Eclampsia, Antepartum

Treatments: Drug: Nifedipine 10 mg; Drug: Labetalol

Study type: Interventional

Funder types: Other

Identifiers

NCT03325348

IRB/2017/306/SIMS

Details and patient eligibility

About

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

Full 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

Enrollment: 194 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

194 participants in 2 patient groups

Oral Nifedipine

Experimental group

Description:

Nifedipine 10mg oral tablet \& 1ml 0.9%N/Saline will be given every 15 minutes up till one hour

Treatment:

Drug: Nifedipine 10 mg

IV Labetalol

Active Comparator group

Description:

IV labetalol 20 mg and mint tablet will be given every 15 minutes up till one hour

Treatment:

Drug: Labetalol