Contact information
Type
Scientific
Primary contact
Prof Neil Poulter
ORCID ID
Contact details
Clinical Pharmacology
Cardiovascular Studies Unit
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
+44 20 7594 3445
n.poulter@ic.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0241048443
Study information
Scientific title
Two studies of blood pressure (BP) elevation associated with pregnancy and the oral contraceptive
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Oral contraceptives
Primary outcome measures
First in a series of collaborative studies between CVSU, Obs & Gynae and Vascular Biology (Clin Pharm).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2000
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
75
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2000
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Pharmacology
London
W2 1NY
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
St Mary's NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary