Nifedipine ER for Postpartum High Blood Pressure

(IPAT Trial)

Overseen By Zaira Peterson

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Medical College of Wisconsin

Disqualifiers: Pre-gestational hypertension, Pre-gestational diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Nifedipine ER, a calcium channel blocker, in controlling high blood pressure after childbirth. Researchers aim to determine if better blood pressure control can enhance long-term heart health for new mothers. Participants are divided into two groups: one follows usual care guidelines, while the other begins treatment at slightly lower blood pressure levels. Women who recently experienced gestational hypertension or preeclampsia and remain hospitalized after childbirth may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Nifedipine ER is likely to be safe for humans?

Research has shown that nifedipine ER is a safe option for managing high blood pressure after childbirth. Studies found that individuals discharged with nifedipine had a 65% lower chance of needing to return for high blood pressure issues, indicating it helps maintain steady blood pressure.

Additional research indicates that nifedipine is well-tolerated and safe for breastfeeding mothers, making it a suitable choice for new moms.

Regarding safety, nifedipine is comparable to other treatments. For instance, the occurrence of small babies was similar for those taking nifedipine and another common medication, labetalol.

Overall, nifedipine ER has proven effective and safe for managing high blood pressure after giving birth. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postpartum high blood pressure?

Unlike the standard of care for postpartum high blood pressure, which typically involves starting medication at a higher blood pressure threshold, this trial explores using Nifedipine ER to manage blood pressure more intensively. The treatment begins at a lower threshold of 140/90 mmHg compared to the usual 150/100 mmHg threshold. This approach aims to maintain lower blood pressure levels, potentially reducing the risk of complications. Researchers are excited because this could lead to better postpartum health outcomes by offering more precise control of blood pressure right after childbirth.

What evidence suggests that Nifedipine ER might be an effective treatment for postpartum high blood pressure?

Research has shown that Nifedipine ER effectively manages high blood pressure. This long-lasting medication relaxes and widens blood vessels, easing blood flow. Studies indicate it works well for controlling high blood pressure after childbirth, which is crucial for reducing future heart problems. In this trial, participants in the intervention arm will receive intensive postpartum blood pressure control with Nifedipine ER. Nifedipine ER is also used for general high blood pressure and is considered safe and effective. In postpartum care, both Nifedipine and Labetalol have demonstrated good results in lowering blood pressure. Overall, Nifedipine ER is a trusted option for managing high blood pressure after childbirth. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 who have been diagnosed with high blood pressure or pre-eclampsia during pregnancy, according to ACOG guidelines. They must be within the first three days postpartum and able to communicate in English or Spanish. Women with pre-existing hypertension, diabetes before pregnancy, plans to transfer hospitals postpartum, nifedipine allergies, or unwillingness to consent are excluded.

Inclusion Criteria

I have been diagnosed with high blood pressure during pregnancy.

I can communicate in English or Spanish.

Postpartum day 0-3 and prior to discharge

Exclusion Criteria

Known allergy to nifedipine or other significant contraindication to nifedipine

Inability or unwillingness to provide informed consent

Intent to transfer postpartum to an outside institution of the participating centers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intensive postpartum BP control with Nifedipine ER versus usual care for 6 weeks postpartum

6 weeks

Monthly virtual educational sessions

Follow-up

Participants are monitored for cardiovascular health, BP, and vascular function up to 12 months postpartum

12 months

Assessments at baseline, 6 weeks, and 12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• NIFEdipine ER

Trial Overview

The study is testing the effects of intensive blood pressure control using NIFEdipine ER after childbirth on long-term cardiovascular health. It aims to reduce chronic hypertension risk and improve vascular function affected by hypertensive disorders during pregnancy.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

Intervention group - intensive postpartum BP control with Nifedipine initiation at SBP≥140 mmHg or DBP≥90 mmHg and maintaining BP at \<140/90 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.

Group II: Active control arm Active Control 1 Intervention

Active control group - a group of usual care that follows ACOG recommendations with Nifedipine initiation at SBP≥150 mmHg or DBP≥100 mm Hg and maintaining BP at \<150/100 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.

NIFEdipine ER is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Nifedipine for:

• Hypertension
• Angina pectoris
• Vasospastic angina

Approved in United States as Nifedipine for:

• Hypertension
• Angina pectoris
• Vasospastic angina
• Chronic stable angina

Approved in Canada as Nifedipine for:

• Hypertension
• Angina pectoris
• Vasospastic angina

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Nifedipine is more effective than other antihypertensives in controlling blood pressure in pregnant women with severe preeclampsia, based on a meta-analysis of nine trials involving 764 women.

Nifedipine also helps prolong gestation without increasing the risk of neonatal respiratory distress syndrome or perinatal deaths, indicating it is a safe option for managing severe preeclampsia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy and perinatal outcome of nifedipine for severe preeclampsia: meta-analysis]. Liu, QQ., Yu, YH., Gong, SP., et al.[2013]

In a randomized trial involving 110 participants with preeclampsia, the use of extended-release nifedipine significantly reduced the need for acute hypertension treatment during labor, with a relative risk of 0.62 compared to placebo.

The nifedipine group also had a lower rate of cesarean deliveries (20.8% vs. 34.7%) and fewer admissions to the neonatal intensive care unit (29.1% vs. 47.1%), suggesting potential benefits for both maternal and neonatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Intrapartum Extended-Release Nifedipine to Prevent Severe Hypertension Among Pregnant Individuals With Preeclampsia With Severe Features. Cleary, EM., Racchi, NW., Patton, KG., et al.[2023]

Nifedipine is considered a safe and effective second-line treatment for hypertension in pregnancy, helping to lower blood pressure and reduce risks of serious maternal complications like cerebral hemorrhage.

While nifedipine shows maternal benefits, its effects on perinatal outcomes are not yet fully established, indicating the need for further clinical trials before it can be recommended as a first-line treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of nifedipine in the hypertensive diseases of pregnancy. Levin, AC., Doering, PL., Hatton, RC.[2017]

In a study involving 3972 patients with mild to moderate essential hypertension, nifedipine demonstrated significant efficacy, with 66.5% of patients achieving a diastolic blood pressure of 90 mmHg or below after one month of treatment.

The safety profile of nifedipine showed expected side effects like flushing and headache, which decreased over time, while ankle edema persisted, indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of nifedipine 20 mg tablets in hypertension using electronic data collection in general practice. Marley, JE.[2022]

In a retrospective study of patients with moderate to severe hypertension during pregnancy, sublingual nifedipine effectively lowered blood pressure without causing hypotension.

The use of nifedipine was associated with satisfactory pregnancy outcomes, indicating it is a safe and effective option for managing obstetric hypertensive emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublingual nifedipine in human pregnancy. Gallery, ED., Györy, AZ.[2019]

In a study involving 33 first-time pregnant women with severe hypertension, both nifedipine and dihydralazine were found to be equally effective in lowering blood pressure.

Nifedipine had a faster onset of action and could be taken orally, making it a more convenient option for managing severe hypertension during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nifedipine in acute hypertensive emergencies in pregnancy. Seabe, SJ., Moodley, J., Becker, P.[2014]

In a study of 31 postpartum patients with severe preeclampsia, nifedipine significantly increased urine output in the first 24 hours after delivery compared to placebo (3834 ml vs. 2057 ml; p < 0.05).

Nifedipine also led to a notable reduction in mean arterial pressure between 18 and 24 hours postpartum (93.9 mm Hg vs. 100.2 mm Hg; p < 0.05), indicating its efficacy in managing blood pressure in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of nifedipine during the postpartum period in patients with severe preeclampsia. Barton, JR., Hiett, AK., Conover, WB.[2022]

In a study of 23 pregnant women with severe hypertension treated with slow-release nifedipine, good blood pressure control was achieved in 20 women, indicating its efficacy in managing hypertension during pregnancy.

However, the treatment was associated with significant risks, including a perinatal mortality rate of 130/1000 and high rates of cesarean sections and premature deliveries, suggesting that its use should be limited to severe cases or controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nifedipine as a second line antihypertensive drug in pregnancy. Constantine, G., Beevers, DG., Reynolds, AL., et al.[2019]

In a study of 213 pregnant women treated with nifedipine as a tocolytic, 32.4% experienced cardiorespiratory adverse effects, with 8.9% suffering serious events like acute pulmonary edema.

Nifedipine significantly decreased maternal blood pressure and increased both maternal and fetal heart rates, indicating the need for close monitoring during its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse effects and hemodynamic effects of nifedipine as a tocolytic]. Spiesser-Robelet, L., Martin, B., Carceller, AM., et al.[2015]

Oral contraceptives (OCs) significantly increased blood pressure and altered sodium and nitric oxide levels in female rats, indicating a risk of hypertension associated with OC use.

The calcium channel blocker nifedipine effectively prevented OC-induced hypertension by improving the body's handling of sodium and nitric oxide, suggesting a potential therapeutic approach to mitigate this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of nifedipine on oral contraceptive-induced hypertension in rats. Olatunji, LA., Soladoye, AO.[2013]

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