Pregnancy And chronic hypertension: NifeDipine or labetalol as Antihypertensive treatment

Phase 1

• Conditions: Chronic hypertension in pregnancy; MedDRA version: 16.1Level: LLTClassification code 10036695Term: Primary hypertensionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 16.1Level: PTClassification code 10039834Term: Secondary hypertensionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 16.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-003144-23-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-30
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•Chronic hypertension (defined as diastolic blood pressure (BP) >=90mmHg present at booking or before 20 weeks' gestation, or requiring treatment outside pregnancy and/or at time of referral)
•Gestation 12-28 weeks’ gestation
•Singleton pregnancy
•Able to provide informed consent
•Age >=18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 114
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Contraindication to labetalol (including asthma, uncontrolled heart failure, Prinzmetal's angina, marked bradycardia, hypotension, sick sinus syndrome, second- or third- degree AV block, cardiogenic shock, metabolic acidosis, severe peripheral arterial disease; phaeochromocytoma) or nifedipine (including cardiogenic shock; advanced aortic stenosis; within 1 month of myocardial infarction; unstable or acute attacks of angina)
•Insufficient understanding of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified