Two studies of blood pressure (BP) elevation associated with pregnancy and the oral contraceptive

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Neil Poulter
Scientific

Clinical Pharmacology
Cardiovascular Studies Unit
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Phone	+44 20 7594 3445
Email	n.poulter@ic.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Two studies of blood pressure (BP) elevation associated with pregnancy and the oral contraceptive
Study objectives	1. Do combined oral contraceptives (COC) exert a differential effect on the blood pressures (BP) of women with and without a past history of BP elevation in pregnancy? 2. Do oral progestrogen only contraceptives produce a significant elevation of BP in women who have had COC-induced hypertension?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular: Hypertension
Intervention	Study 1 (controlled trial): 25 women who have developed significant BP elevation during pregnancy and 25 who have never suffered raised BP during pregnancy will receive combined oral contraceptives. Study 2 (randomised controlled trial): 50 women with a history of raised BP in association with taking oral contraceptives will be randomised to receive a progestrogen-only contraceptive versus a placebo.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Oral contraceptives
Primary outcome measure(s)	First in a series of collaborative studies between CVSU, Obs & Gynae and Vascular Biology (Clin Pharm).
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	75
Key inclusion criteria	Study 1 - 25 women who have developed significant BP elevation and 25 who have never suffered raised BP during pregnancy. Study 2 - 50 women with a history of raised BP in association with taking oral contraceptive.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2000
Date of final enrolment	31/12/2005

Clinical Pharmacology

London
W2 1NY
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

08/06/2017: No publications found in PubMed, verifying study status with principal investigator