A Manchikanti1, D A Grimes, L M Lopez, K F Schulz. 1. Family Health International, Clinical Research Department, P.O.Box 13950, Durham, North Carolina 27709, USA. anupama@unc.edu
Abstract
BACKGROUND: Whether steroid contraceptives are appropriate for women with homozygous sickle cell (SS) disease remains unresolved. Historically, women with SS disease have experienced difficult pregnancies, characterized by high rates of maternal mortality and morbidity and poor infant outcomes. Unresolved questions about steroidal contraceptives in women with SS disease include whether using them may promote blood clots. OBJECTIVES: To assess the safety of steroid hormones in this setting, we retrieved and analyzed all randomized controlled trials that examined steroid hormones for contraception in women with SS disease. SEARCH STRATEGY: We searched the computerized databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, POPLINE and EMBASE (each from its inception to November, 2005) for randomized controlled trials of steroid hormone use for contraception in women with SS disease. We examined the reference list of each trial as well as that of review articles. SELECTION CRITERIA: We included any randomized controlled trial in any language that compared steroid hormones for contraception with another contraceptive or placebo. Frequency or intensity of sickle pain crises must have been reported as an outcome. DATA COLLECTION AND ANALYSIS: We assessed for inclusion all titles and abstracts found. We evaluated the methodological quality of the trial found for potential biases by qualitatively assessing the study design, randomization method, allocation concealment, blinding, premature discontinuation rates, and loss to follow-up rates. We entered trial results in RevMan and reported Peto odds ratios with 95% confidence intervals for dichotomous outcomes, such as occurrence of sickle pain crises. MAIN RESULTS: Only one trial met the inclusion criteria. Twenty-five patients were randomized to three monthly depo-medroxyprogesterone acetate (DMPA) or intramuscular saline placebo injections in a crossover design. A six-month washout period was implemented before the crossover; however, pharmacological evidence indicates that levels of DMPA may be detected for more than 200 days after the injection. During DMPA use, women were less likely to experience painful sickle episodes (OR 0.23; 95% CI 0.05 to 1.02). No trial involved estrogen products. AUTHORS' CONCLUSIONS: The limited available data suggest that DMPA is a safe contraceptive option for women in SS disease. In addition to providing effective contraception, DMPA may reduce sickle pain crises.
BACKGROUND: Whether steroid contraceptives are appropriate for women with homozygous sickle cell (SS) disease remains unresolved. Historically, women with SS disease have experienced difficult pregnancies, characterized by high rates of maternal mortality and morbidity and poor infant outcomes. Unresolved questions about steroidal contraceptives in women with SS disease include whether using them may promote blood clots. OBJECTIVES: To assess the safety of steroid hormones in this setting, we retrieved and analyzed all randomized controlled trials that examined steroid hormones for contraception in women with SS disease. SEARCH STRATEGY: We searched the computerized databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, POPLINE and EMBASE (each from its inception to November, 2005) for randomized controlled trials of steroid hormone use for contraception in women with SS disease. We examined the reference list of each trial as well as that of review articles. SELECTION CRITERIA: We included any randomized controlled trial in any language that compared steroid hormones for contraception with another contraceptive or placebo. Frequency or intensity of sickle pain crises must have been reported as an outcome. DATA COLLECTION AND ANALYSIS: We assessed for inclusion all titles and abstracts found. We evaluated the methodological quality of the trial found for potential biases by qualitatively assessing the study design, randomization method, allocation concealment, blinding, premature discontinuation rates, and loss to follow-up rates. We entered trial results in RevMan and reported Peto odds ratios with 95% confidence intervals for dichotomous outcomes, such as occurrence of sickle pain crises. MAIN RESULTS: Only one trial met the inclusion criteria. Twenty-five patients were randomized to three monthly depo-medroxyprogesterone acetate (DMPA) or intramuscular saline placebo injections in a crossover design. A six-month washout period was implemented before the crossover; however, pharmacological evidence indicates that levels of DMPA may be detected for more than 200 days after the injection. During DMPA use, women were less likely to experience painful sickle episodes (OR 0.23; 95% CI 0.05 to 1.02). No trial involved estrogen products. AUTHORS' CONCLUSIONS: The limited available data suggest that DMPA is a safe contraceptive option for women in SS disease. In addition to providing effective contraception, DMPA may reduce sickle pain crises.