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  • Title: A multicentre study of coagulation and haemostatic variables during oral contraception: variations with four formulations. Task Force on Oral Contraceptives--WHO Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland.
    Journal: Br J Obstet Gynaecol; 1991 Nov; 98(11):1117-28. PubMed ID: 1760424.
    Abstract:
    OBJECTIVE: To explore the extent to which progestogen type and oestrogen and progestogen dose may modify the effects of combined oral contraceptives (OC) on coagulation and haemostasis. DESIGN: Randomized double-blind clinical trial. SETTING: Gynaecological clinics in Salvador (Brazil), Santiago (Chile), Singapore, and Dublin (Ireland). SUBJECTS: 622 women aged 18-35 years who had opted for oral contraception. A contrast group of 155 women who were not to receive OC was also studied. Both groups included approximately equal numbers from each of the four centres. INTERVENTIONS: Treatment of approximately equal numbers of women at each centre with one of the following OC preparations for at least 12 months: Norethisterone acetate (NEA) 1 mg + ethinyl oestradiol (EE) 50 micrograms; levonorgestrel (LNG) 250 micrograms + EE 50 micrograms; LNG 250 micrograms + EE 30 micrograms; LNG 150 micrograms + EE 30 micrograms. MAIN OUTCOME MEASURES: Changes over 12 months in 12 coagulation and haemostatic variables. RESULTS: At 12-month follow-up, the women on each OC preparation showed acceleration of prothrombin time and increase in factor X and fibrinogen. With the OC containing NEA there was also a persistent rise in factor VIIC, and reduction of antithrombin III and alpha 2-antiplasmin. The formulation which contained low doses of both LNG and EE showed the least adverse coagulation changes. Large increases in fibrinolysis were found in all OC groups. CONCLUSIONS: The adverse effects of combined OC on clotting are affected by the type and dose of progestogen as well as the dose of oestrogen.
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