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

ISRCTN	ISRCTN00582888
DOI	https://doi.org/10.1186/ISRCTN00582888
Secondary identifying numbers	N0241048443

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 08/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

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

Contact information

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Oral contraceptives
Primary outcome measure	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 study start date	01/08/2000
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clinical Pharmacology

London
W2 1NY
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

St Mary's NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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