Research Highlights:
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Trial of Intrapartum Extended-Release Nifedipine to Prevent Severe Hypertension Among Pregnant Women With Preeclampsia with Severe Features
Summary
Background
Preeclampsia is associated with maternal and perinatal morbidity. In addition to acute therapy for severe hypertension, best practices for the management of intrapartum hypertension are lacking. Our objective was to test the hypothesis that intrapartum initiation of extended-release nifedipine in individuals with preeclampsia with severe features prevents severe hypertension.
Methods:
Randomized, triple-blind, placebo-controlled trial of people with preeclampsia with severe features undergoing induction of labor between 220/7 and 416/7 weeks of gestation. Participants were randomly assigned to 30 mg of oral extended-release nifedipine or an identical placebo every 24 hours.
The primary outcome is defined as receipt of ≥1 dose of acute hypertension therapy for severe blood pressure (≥160/110 mm Hg) sustained ≥10 minutes. Secondary outcomes included route of delivery, neonatal intensive care unit admission, and a composite of adverse neonatal outcomes.
Results:
Of 365 individuals evaluated, 55 were randomized to nifedipine and 55 to placebo. The primary outcome was observed in 34.0% of individuals in the nifedipine group versus 55.1% in the placebo group (relative risk [RR] 0.62 [95% CI, 0.39–0.97] ); the number needed to treat to avoid receiving acute treatment was 4.7 (95% CI, 2.5–44.3). Fewer individuals in the nifedipine group required cesarean delivery compared with the placebo group (20.8% versus 34.7%, RR, 0.60 [95% CI, 0.31–1.15]).
The rate of admission to the neonatal intensive care unit was lower in the nifedipine group compared with placebo (29.1% versus 47.1%; RR, 0.62 [95% CI, 0.37–1 .02]). The neonatal composite was similar between groups (35.8% versus 41.2%, RR, 0.83 [95% CI, 0.51–1.37]).
Conclusions:
Initiation of extended-release nifedipine is effective in reducing intrapartum acute antihypertensive therapy among persons with preeclampsia with severe features.
Comments
A new study in the journal Hypertension found that daily blood pressure medications taken after the diagnosis of severe preeclampsia and the decision to continue delivery can also prevent complications for the mother and/or baby
Women with severe preeclampsia (severe high blood pressure) during pregnancy can be treated with extended-release nifedipine, a blood pressure-lowering medication, daily during labor and delivery, according to new research published today in Hypertension, a journal of the American Heart Association. . Women treated with the drug were less likely to experience dangerously high blood pressure that would require treatment with fast-acting medications, including intravenous (IV) medications.
The study examined whether treatment with nifedipine, a long-release blood pressure lowering medication, before labor and delivery, can prevent the development of severe blood pressure levels and, as a result, avoid the need for medication. fast-acting intravenous.
According to the American Heart Association, preeclampsia is usually diagnosed after 20 weeks of pregnancy and indicates high blood pressure with symptoms such as headaches, vision changes, and swelling of the hands, feet, face, or eyes. eyes.
A diagnosis of preeclampsia with severe features usually includes systolic blood pressure (the highest number on a blood pressure measurement) of 160 mm Hg or higher and/or diastolic blood pressure (the lowest number on a blood pressure measurement) of 110 mm Hg or more and high levels of protein in the urine. It affects up to 8% of pregnancies and increases the risk of stroke, liver or kidney damage, and preterm birth (delivery before 40 weeks).
Delivering the baby is the only way to begin curing preeclampsia and the symptoms usually disappear within a few days of delivery. However, some women continue to need blood pressure medication for six weeks after giving birth or longer.
“We know that reducing very high blood pressure to a safer range will help prevent maternal and fetal complications. However, other than fast-acting intravenous medications for severe hypertension during pregnancy, optimal management of hypertension during labor and delivery has not been studied,” said the study’s lead author, Erin M. Cleary. , MD, a fetal motherhood fellow at The Ohio State University in Columbus, Ohio, when the study was conducted.
Severe high blood pressure also increases the risk of complications such as placental abruption, where the placenta, which supplies nutrients and oxygen from the mother to the baby developing in the womb, detaches from the uterus before the baby is born. This can lead to serious complications for the mother and/or baby.
“Some of these complications can include emergency delivery, maternal blood loss, and can be life-threatening for both mother and baby,” Cleary said. “About 10% of patients treated with rapid intravenous treatment for very high blood pressure may have very low blood pressures quickly. “When blood pressure drops too much, too quickly, it can lead to other serious complications.”
The study was conducted between June 2020 and April 2022 at The Ohio State University Wexner Medical Center in Columbus and included 110 women who were at least 22 weeks pregnant, who had been diagnosed with severe preeclampsia and were I had induced labor. Half of the participants were randomly assigned to take one 30 mg nifedipine extended-release pill every day until delivery, the other half of the participants were randomly assigned to take a placebo pill every day until delivery. .
Neither the study investigators, the clinical care team, nor the women knew whether they had been assigned nifedipine or placebo. Participants were followed until hospital discharge and a chart review was performed for 6 weeks postpartum to monitor any postpartum readmission along with reasons for readmission.
The researchers also examined the impact of nifedipine treatment on delivery, whether and for how long the baby needed care in the neonatal intensive care unit (NICU), and other adverse outcomes for the mother and/or baby.
The study found:
34% of women in the nifedipine group needed treatment for acute hypertension (immediate reduction in blood pressure) compared with 55.1% of those in the placebo group.
There were fewer cesarean deliveries among women treated with nifedipine: 20.8% of women in the nifedipine treatment group had a cesarean section, compared with 34.7% of women in the placebo group.
The rate of NICU admission for newborns was lower if the mother received nifedipine treatment (29.1%) compared with the placebo group (47.1%).
Poor outcomes for the baby, such as a lower Apgar score, low blood sugar, high bilirubin, or need for extra oxygen, did not differ significantly between the two treatment groups.
However, it is important to note that the number of participants in this study was too small to determine whether the differences in NICU and C-section rates may be true or whether they may be due to chance or other factors. The researchers plan to conduct larger studies with more participants to better understand whether these differences are valid.
A March 2021 American Heart Association scientific statement, Adverse Pregnancy Outcomes and Risk of Cardiovascular Disease: Unique Opportunities for Preventing Cardiovascular Disease in Women, details pregnancy-related complications that increase a woman’s risk of developing cardiovascular disease after childbirth: high blood pressure, gestational diabetes, preterm birth, small-for-gestational-age birth, preeclampsia, pregnancy loss, or placental abruption. The statement calls for vigorous primary prevention of cardiovascular diseases (CVD), prevention of CVD risk factors during pregnancy, and follow-up to monitor CVD risk throughout life.
Co-authors are Nicholas W. Racchi, DO; K. Grace Patton, MD; Meghana Kudrimoti, B.S.; Maged M. Costantine, MD; and Kara M. Rood, MD Author disclosures are listed in the manuscript. The study was funded by the Department of Obstetrics and Gynecology at The Ohio State University.
