Abstract
BackgroundThe behavior of arterial blood pressure in postpartum of women with hypertension and pregnancy and the best treatment for very high blood pressure in this period still need evidence. The Cochrane systematic review assessing prevention and treatment of postpartum hypertension found only two trials (120 patients) comparing hydralazine with nifedipine and labetalol for the treatment of severe hypertension and did not find enough evidence to know how best to treat women with hypertension after birth. Although studies have demonstrated the effectiveness of treatment with captopril, side effects were reported. Because of these findings, new classes of antihypertensive drugs began to be administered as an alternative therapy. Data on the role of clonidine in this particular group of patients, its effects in the short and long term are still scarce in the literature.ObjectivesTo determine the effectiveness of clonidine, compared to captopril, for the treatment of postpartum very high blood pressure in women with hypertension in pregnancy.Methods/designThe study is a triple blind randomized controlled trial including postpartum women with diagnosis of hypertension in pregnancy presenting very high blood pressure, and exclusion criteria will be presence of heart disease, smoking, use of illicit drugs, any contraindication to the use of captopril or clonidine and inability to receive oral medications.Eligible patients will be invited to participate and those who agree will be included in the study and receive captopril or clonidine according to a random list of numbers. The subjects will receive the study medication every 20 minutes until blood pressure is over 170 mmHg of systolic blood pressure and 110 mmHg diastolic blood pressure. A maximum of six pills a day for very high blood pressure will be administered. In case of persistent high blood pressure levels, other antihypertensive agents will be used.During the study the women will be subject to strict control of blood pressure and urine output. This proposal has already obtained approval of the local Institutional Review Board of the coordinating center (IMIP, Recife, Brazil) and of the National Council for Ethics in Research (CONEP) of the Brazilian Ministry of Health.Trial registrationClinical Trials Register under the number NCT01761916.
Highlights
Hypertension complicates approximately 10% of pregnancies [1] and is the leading cause of maternal death in Brazil [2] and the third leading cause in the world [3]
Much has been studied about the repercussions of hypertension for the mother and the fetus, but there are relatively few studies evaluating the behavior of postpartum blood pressure, its impact and what is the better pharmacological treatment during this period [6,7,8,9,10,11]
According to a recent review of the etiology and management of postpartum hypertension-preeclampsia the reported prevalence of new onset postpartum hypertension or preeclampsia ranges from 0.3–27.5% [6]
Summary
Hypertension complicates approximately 10% of pregnancies [1] and is the leading cause of maternal death in Brazil [2] and the third leading cause in the world [3] It entails increased maternal morbidity associated with complications such as eclampsia, HELLP syndrome, hemorrhage, pulmonary edema, renal failure and coma [4]. The behavior of arterial blood pressure in postpartum of women with hypertension and pregnancy and the best treatment for very high blood pressure in this period still need evidence. Studies have demonstrated the effectiveness of treatment with captopril, side effects were reported Because of these findings, new classes of antihypertensive drugs began to be administered as an alternative therapy. Data on the role of clonidine in this particular group of patients, its effects in the short and long term are still scarce in the literature
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