Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial.

BACKGROUND: Hypertension is the most common medical disorder in pregnancy, complicating one in ten pregnancies. Treatment of severely increased blood pressure is widely recommended to reduce the risk for maternal complications. Regimens for the acute treatment of severe hypertension typically include intravenous medications. Although effective, these drugs require venous access and careful fetal monitoring and might not be feasible in busy or low-resource environments. We therefore aimed to compare the efficacy and safety of three oral drugs, labetalol, nifedipine retard, and methyldopa for the management of severe hypertension in pregnancy. METHODS: In this multicentre, parallel-group, open-label, randomised controlled trial, we compared these oral antihypertensives in two public hospitals in Nagpur, India. Pregnant women were eligible for the trial if they were aged at least 18 years; they were pregnant with fetuses that had reached a gestational age of at least 28 weeks; they required pharmacological blood pressure control for severe hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg); and were able to swallow oral medications. Women were randomly assigned to receive 10 mg oral nifedipine, 200 mg oral labetalol (hourly, in both of which the dose could be escalated if hypertension was maintained), or 1000 mg methyldopa (a single dose, without dose escalation). Masking of participants, study investigators, and care providers to group allocation was not possible because of different escalation protocols in the study groups. The primary outcome was blood pressure control (defined as 120-150 mm Hg systolic blood pressure and 70-100 mm Hg diastolic blood pressure) within 6 h with no adverse outcomes. This study is registered with ClinicalTrials.gov, number NCT01912677, and the Clinical Trial Registry, India, number ctri/2013/08/003866. FINDINGS: Between April 1, 2015, and Aug 21, 2017, we screened 2307 women for their inclusion in the study. We excluded 1413 (61%) women who were ineligible, declined to participate, had impending eclampsia, were in active labour, or had a combination of these factors. 11 (4%) women in the nifedipine group, ten (3%) women in the labetalol group, and 11 (4%) women in the methyldopa group were ineligible for treatment (because they had only one qualifying blood pressure measurement) or had treatment stopped (because of delivery or transfer elsewhere). 894 (39%) women were randomly assigned to a treatment group and were included in the intention-to-treat analysis: 298 (33%) women were assigned to receive nifedipine, 295 (33%) women were assigned to receive labetalol, and 301 (33%) women were assigned to receive methyldopa. The primary outcome was significantly more common in women in the nifedipine group than in those in the methyldopa group (249 [84%] women vs 230 [76%] women; p=0·03). However, the primary outcome did not differ between the nifedipine and labetalol groups (249 [84%] women vs 228 [77%] women; p=0·05) or the labetalol and methyldopa groups (p=0·80). Seven serious adverse events (1% of births) were reported during the study: one (<1%) woman in the labetalol group had an intrapartum seizure and six (1%) neonates (one [<1%] neonate in the nifedipine group, two [1%] neonates in the labetalol group, and three [1%] neonates in the methyldopa group) were stillborn. No birth had more than one adverse event. INTERPRETATION: All oral antihypertensives reduced blood pressure to the reference range in most women. As single drugs, nifedipine retard use resulted in a greater frequency of primary outcome attainment than labetalol or methyldopa use. All three oral drugs-methyldopa, nifedipine, and labetalol-are viable initial options for treating severe hypertension in low-resource settings. FUNDING: PREEMPT (University of British Columbia, Vancouver, BC, Canada; grantee of Bill & Melinda Gates Foundation).

Calibrated delivery drape versus indirect gravimetric technique for the measurement of blood loss after delivery: a randomized trial.

BACKGROUND: Trials of interventions for PPH prevention and treatment rely on different measurement methods for the quantification of blood loss and identification of PPH. This study's objective was to compare measures of blood loss obtained from two different measurement protocols frequently used in studies. METHODS: Nine hundred women presenting for vaginal delivery were randomized to a direct method (a calibrated delivery drape) or an indirect method (a shallow bedpan placed below the buttocks and weighing the collected blood and blood-soaked gauze/pads). Blood loss was measured from immediately after delivery for at least one hour or until active bleeding stopped. RESULTS: Significantly greater mean blood loss was recorded by the direct than by the indirect measurement technique (253.9 mL and 195.3 mL, respectively; difference = 58.6 mL (95% CI: 31-86); p < 0.001). Almost twice as many women in the direct than in the indirect group measured blood loss > 500 mL (8.7% vs. 4.7%, p = 0.02). CONCLUSIONS: The study suggests a real and significant difference in blood loss measurement between these methods. Research using blood loss measurement as an endpoint needs to be interpreted taking measurement technique into consideration. TRIAL REGISTRATION: This study has been registered at clinicaltrials.gov as NCT01885845.

Policy maker and health care provider perspectives on reproductive decision-making amongst HIV-infected individuals in South Africa.

BACKGROUND: Worldwide there is growing attention paid to the reproductive decisions faced by HIV-infected individuals. Studies in both developed and developing countries have suggested that many HIV-infected women continue to desire children despite knowledge of their HIV status. Despite the increasing attention to the health care needs of HIV-infected individuals in low resource settings, little attention has been given to reproductive choice and intentions. Health care providers play a crucial role in determining access to reproductive health services and their influence is likely to be heightened in delivering services to HIV-infected women. We examined the attitudes of health care policy makers and providers towards reproductive decision-making among HIV-infected individuals. METHODS: In-depth interviews were conducted with 14 health care providers at two public sector health care facilities located in Cape Town, South Africa. In addition, 12 in-depth interviews with public sector policy makers and managers, and managers within HIV/AIDS and reproductive health NGOs were conducted. Data were analyzed using a grounded theory approach. RESULTS: Providers and policy makers approached the issues related to being HIV-infected and child bearing differently. Biomedical considerations were paramount in providers' approaches to HIV infection and reproductive decision-making, whereas, policy makers approached the issues more broadly recognizing the structural constraints that inform the provision of reproductive health care services and the possibility of "choice" for HIV-infected individuals. CONCLUSION: The findings highlight the diversity of perspectives among policy makers and providers regarding the reproductive decisions taken by HIV-infected people. There is a clear need for more explicit policies recognizing the reproductive rights and choices of HIV-infected individuals.

Alternatives to a routine follow-up visit for early medical abortion.

OBJECTIVE: To evaluate the ability of women and their providers to assess abortion outcome without the routine use of ultrasonography. METHODS: This multicenter trial enrolled 4,484 women seeking medical abortion at 10 clinics in the United States. Women received the standard medical abortion care with mifepristone-misoprostol in those clinics and blinded clinical assessments before follow-up ultrasonography. Data were collected prospectively on abortion outcomes, receipt of additional treatment, and clinical, laboratory, and ultrasound assessments associated with the procedure. We constructed five model algorithms for evaluating women's postabortion status, each using a different assortment of data. Four of the algorithms (algorithms 1-4) rely on data collected by the woman and on the results of the low-sensitivity pregnancy test. Algorithm 5 relies on the woman's assessment, the results of the pregnancy test, and follow-up physician assessment (sometimes including bimanual or speculum examination). RESULTS: A total of 3,054 women received medical abortion and had adequate data for evaluation. Twenty women (0.7%) had an ongoing pregnancy; 26 (0.9%) received curettage for retained tissue, empiric treatment for possible infection, or both; and 55 (1.8%) received additional uterotonics or other medical abortion-related care. Screening algorithms including patient-observed outcomes, a low-sensitivity pregnancy test, and nonsonographic clinical evaluation were as effective as sonography in identifying women who received interventions at or after the follow-up visit. CONCLUSION: Relying on women's observations, a low-sensitivity pregnancy test, and clinical examination, women and their providers can accurately assess whether follow-up care is required after medical abortion without routine ultrasonography. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00120224. LEVEL OF EVIDENCE: II.