Treatment for Hypertension, Pregnancy-Induced

Phase-Based Estimates
3
Effectiveness
3
Safety
LA County Hospital/University of Southern California, Los Angeles, CA
Hypertension, Pregnancy-Induced+6 More
Eligibility
18+
Female
Eligible conditions
Hypertension, Pregnancy-Induced

Study Summary

Postpartum NSAIDS and Maternal Hypertension

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Eligible Conditions

  • Hypertension, Pregnancy-Induced
  • Pre-Eclampsia
  • Hypertension
  • prophylaxis of preeclampsia
  • Superimposed Preeclampsia
  • Chronic Hypertension in Obstetric Context
  • Gestational Hypertension

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 9 secondary outcomes in patients with Hypertension, Pregnancy-Induced. Measurement will happen over the course of From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum.

Hour 96
Proportion of participants with blood pressure elevation
Week 6
Number of participants who die
Day 7
Initiation of anti-hypertensive medication
Day 7
Pain numerical rating scale (NRS) score
Day 7
Length of hospital stay
Week 6
Number of participants with eclamptic Seizure
Number of participants with pulmonary edema
Number of participants with renal failure
Number of participants with stroke

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Standard Postpartum Care without NSAIDs

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Standard Postpartum Care without NSAIDs
Other
Subjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider.
Standard Postpartum Care
Drug
Subjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48, 72 and 96 hours postpartum
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 48, 72 and 96 hours postpartum for reporting.

Who is running the study

Principal Investigator
R. H. L.
Prof. Richard H. Lee, Associate Professor
University of Southern California

Closest Location

LA County Hospital/University of Southern California - Los Angeles, CA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The doctor diagnoses antenatal hypertensive disorder by examining the symptoms and doing some tests show original
Women who are 18 years or older and deliver their babies at LAC/USC Hospital will have the opportunity to participate in a new study show original
Delivery occurring at or after 20 weeks gestation

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of hypertension, pregnancy-induced?

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There are significant signs of pregnancy-related hypertension. These include high blood pressure as detected by examination, low blood pressure during pregnancy, and fetal growth restriction. More research into the natural history of gestational hypertension is needed to more thoroughly assess the role of the risk factors.

Unverified Answer

What is hypertension, pregnancy-induced?

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In the United States, the rate of stroke in elderly women is 2- to 5-fold higher than that of men. Pregnancy-induced hypertension increases risk of stroke in women younger than 50 years.

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Can hypertension, pregnancy-induced be cured?

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The major limitation of our study is that it was a cross sectional study carried out at a tertiary hospital, which can be a bias. The study was based on retrospective data which can make some generalisations difficult.

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What causes hypertension, pregnancy-induced?

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In women who become pregnant the risk of developing hypertension increases. The cause is likely to be related to a combination of factors in the fetus and during pregnancy.

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What are common treatments for hypertension, pregnancy-induced?

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Treatments for hypertension in pregnancy are based on lifestyle change and are dependent on the indication for which the treatment is prescribed. Medications such as nifedipine and amlodipine, antiadrenoceptor agents and nitric oxide are commonly used in pregnancy. In addition to conventional and alternative approaches, acupuncture and alternative medicines may be used. Knowledge of which treatments are used is an important aspect of comprehensive management.

Unverified Answer

How many people get hypertension, pregnancy-induced a year in the United States?

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About 31% of women (n = 1.7 million) report hypertension, pregnancy-induced in the previous year. Although hypertension is recognized as an important risk factor for poor cardiovascular outcomes, it is possible that women with diabetes are at greater risk for pregnancy-induced hypertension when compared to women without diabetes. The effect of obesity on this risk appears to depend on the presence of diabetes.

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What is the latest research for hypertension, pregnancy-induced?

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Hypertension affects more than 2 million pregnant women in the United States. Studies of the benefits of exercise for postnatal hypertension are small, have poor methodological quality, and are of low-quality evidence. No evidence suggests that exercise plus dietary changes have any advantages over dietary advice alone, although some studies suggest a small beneficial effect. This review lists the best available evidence.

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What are the latest developments in treatment for therapeutic use?

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The present review confirms that the therapeutic use of the antihypertensive drug tolbutamide in pregnancy is still the main treatment for hypertension in pregnancy. For therapeutic use, the data from recent clinical trials support the idea that tolbutamide may be particularly effective compared to other drugs. But despite these advances, many women with tolbutamide-induced hypertension in pregnancy are still not treated.

Unverified Answer

Who should consider clinical trials for hypertension, pregnancy-induced?

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[Hypertension should be considered in pregnancy for all women irrespective of their risk of developing CHD or stroke. The majority of these women will not benefit. Patients with risk factors for hypertension and CHD, preeclampsia and/or severe pre-existing hypertension should be offered more rigorous treatment for these diseases with the provision of alternative therapies in case of treatment failure. Clinical trials conducted in hospitals on a large scale need a long-term commitment from physicians and institutional authorities. It is therefore appropriate to conduct clinical trials in low-risk women under close supervision in low-risk settings.

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What is the average age someone gets hypertension, pregnancy-induced?

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The average age of people diagnosed with hypertension is 48 yr in Canada and 65 yr in the US, and pregnancies induced earlier may affect the incidence of preeclampsia. The highest average age of diagnosis was found among women with diabetes and hypertension.

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Has treatment proven to be more effective than a placebo?

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A single-blind treatment with low-dose amlodipine was well tolerated, with treatment-related reductions in blood pressure and a placebo-adjusted 12-step walking distance. Longitudinal data will be published soon.

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What is treatment?

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Although hypertension is common, most women will not require medications to treat HTN during pregnancy. Pregnant women have increased risk for HTN, therefore antihypertensive medication should be initiated early and continued even after the birth. We are not able to estimate if or when the need for medications in postpartum is the same. There still is no good evidence to recommend medication in the postpartum period to decrease HTN, which can be very dangerous in preeclampsia. Only good quality research can provide us this evidence.

Unverified Answer
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