Nifedipine for Acute Tocolysis of Preterm Labor

Hawkins, J. Seth; Wells, C. Edward; Casey, Brian M.; McIntire, Donald D.; Leveno, Kenneth J.

doi:10.1097/aog.0000000000004436

Cited by 8 publications

(8 citation statements)

References 10 publications

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“…Treatment of preterm labor is based on the inhibition of uterine contractions. Nifedipine is one of the most preferred tocolytic agents [14][15][16]. Unlike the previous study that states that there was a risk of placental hypoperfusion and maternal hypotension from decreased uterine blood flow due to the vasodilation effect it has on smooth muscles, this effect was confirmed in two recent studies [17,18].…”

Section: Discussionmentioning

confidence: 81%

Effect of Nifedipine Used in the Treatment of the Threat of Preterm Labor on Total Uterine Artery Blood Volume Flow Rate

Eroğlu¹,

Turğal²,

Altınboğa³

et al. 2023

Z Geburtshilfe Neonatol

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Purpose Evaluation of the effect of maternal nifedipine treatment on total uterine artery blood volume flow rate (TVFR). Methods In this prospective study, 43 women who were admitted to the Perinatology Department of the University of Health Sciences Etlik Zübeyde Hanım Gynecology Training and Research Hospital, with the diagnosis of the threat of preterm labor, and 40 healthy pregnant women, who were randomly selected as the control group, were evaluated between July 1, 2018, and September 1, 2018. A transabdominal ultrasound examination of uterine arteries was performed both before and 48 hours after administration of oral nifedipine for TVFR measurement. For the final analysis, the TVFR levels of the group diagnosed with the threat of preterm labor and the control group were compared. Results There was no significant difference in either uterine artery pulsatility index or resistance index values as well as the diameters of the uterine arteries after nifedipine treatment (p>0.05 for all). Total uterine artery blood volume flow rate (TVFR) was 424.66±236.74 mL/min before and 543.39±309.68 mL/min after treatment with nifedipine and was statistically significantly higher (p < 0.05). ConclusionsOur study showed a statistically significant increase in total uterine artery blood volume flow rate 48 hours after oral nifedipine treatment.

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Section: Discussionmentioning

confidence: 81%

Effect of Nifedipine Used in the Treatment of the Threat of Preterm Labor on Total Uterine Artery Blood Volume Flow Rate

Eroğlu¹,

Turğal²,

Altınboğa³

et al. 2023

Z Geburtshilfe Neonatol

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“…Generating such information for clinicians can help to address the current gap between nifedipine maternal and fetal exposure and neonatal outcomes. 2,4,51 In conclusion, a detailed mechanistic PBPK model has been developed in this work to predict the maternalplacental-fetal PK of nifedipine. The model can provide insight into the nifedipine placental and fetal exposure helping to better understand the mechanisms of nifedipine distribution and elimination within the fetalplacental unit.…”

Section: Discussionmentioning

confidence: 99%

“…Nifedipine has been extensively used in the treatment of mild to severe hypertension for pregnant women and as a tocolytic agent to prevent preterm labor. [2][3][4] Twenty-seven years have passed since then and there are still many questions to be answered on this topic. Administering nifedipine during pregnancy is believed to carry varying levels of teratogenic risks.…”

mentioning

confidence: 99%

Mechanistic Framework to Predict Maternal‐Placental‐Fetal Pharmacokinetics of Nifedipine Employing Physiologically Based Pharmacokinetic Modeling Approach

Werdan Romão,

Pinto,

Cavalli

et al. 2024

The Journal of Clinical Pharma

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Nifedipine is used for treating mild to severe hypertension and preventing preterm labor in pregnant women. Nevertheless, concerns about nifedipine fetal exposure and safety are always raised. The aim of this study was to develop and validate a maternal‐placental‐fetal nifedipine physiologically based pharmacokinetic (PBPK) model and apply the model to predict maternal, placental, and fetal exposure to nifedipine at different pregnancy stages. A nifedipine PBPK model was verified with nonpregnant data and extended to the pregnant population after the inclusion of the fetoplacental multicompartment model that accounts for the placental tissue and different fetal organs within the Simcyp Simulator version 22. Model parametrization involved scaling nifedipine transplacental clearance based on Caco‐2 permeability, and fetal hepatic clearance was obtained from in vitro to in vivo extrapolation encompassing cytochrome P450 3A7 and 3A4 activities. Predicted concentration profiles were compared with in vivo observations and the transplacental transfer results were evaluated using 2‐fold criteria. The PBPK model predicted a mean cord‐to‐maternal plasma ratio of 0.98 (range, 0.86‐1.06) at term, which agrees with experimental observations of 0.78 (range, 0.59‐0.93). Predicted nifedipine exposure was 1.4‐, 2.0‐, and 3.0‐fold lower at 15, 27, and 39 weeks of gestation when compared with nonpregnant exposure, respectively. This innovative PBPK model can be applied to support maternal and fetal safety assessment for nifedipine at various stages of pregnancy.

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“…When event numbers are small, the degree of certainty around them is diminished, and this is reflected in wide confidence intervals (CI). For example, in a recent small randomized trial of 90 participants randomized to nifedipine or placebo for management of preterm labor, 17 the investigators reported a relative risk of delivery before 37 weeks of 1.1 (95% CI: 0.7-1.7). The 95% CI demonstrates that the true point estimate is most likely to be somewhere between 0.70 and 1.7, which represents anywhere from a 30% reduction in preterm birth rates, to almost a 2-fold increase in rates.…”

Section: Overcoming Challenges: Composite and Surrogate Outcomes Imba...mentioning

confidence: 99%

Assessment and Interpretation of Small or Underpowered Randomized Clinical Trials

Ayala¹,

Rouse²

2022

Clinical Obstetrics &Amp; Gynecology

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The randomized controlled trial has long been recognized as the gold standard of research designs. As small or underpowered trials have become increasingly common in obstetrics and gynecology, it is essential to appraise the trial design and results with a critical eye and understand the limitations of these trials including the potential for selection bias, inability to discriminate uncommon outcomes and the imprecision of point estimates. When small or underpowered trials are designed to be assessed in combination with other trials in high-quality meta-analysis, some of these limitations are minimized.

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Nifedipine for Acute Tocolysis of Preterm Labor

Abstract: Personal or nonessential information may be redacted at the editor's discretion.

Cited by 8 publications

References 10 publications

Effect of Nifedipine Used in the Treatment of the Threat of Preterm Labor on Total Uterine Artery Blood Volume Flow Rate

Effect of Nifedipine Used in the Treatment of the Threat of Preterm Labor on Total Uterine Artery Blood Volume Flow Rate

Mechanistic Framework to Predict Maternal‐Placental‐Fetal Pharmacokinetics of Nifedipine Employing Physiologically Based Pharmacokinetic Modeling Approach

Assessment and Interpretation of Small or Underpowered Randomized Clinical Trials

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