Clinical trial NCT04790279
Conditions: Hypertension in Pregnancy
Sponsor: Prisma Health-Upstate
Start date: 2021-04-09; Completion date: 2023-01-25
Enrollment: 175 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A significant number of pregnancies are complicated by hypertensive disorders. Hypertension often worsens in the postpartum period and many women need started on medications. Currently, recommended medications for blood pressure management in pregnant and postpartum women are limited, with labetalol and nifedipine ER being the most commonly used medications. While these medications are both effective, they are not without limitations. Amlodipine is a medication in the same class as nifedipine ER. It is a first-line antihypertensive in the general population. It tends to have less side effects than nifedipine ER. It has not been studied specifically in postpartum women. The purpose of this study is to determine if amlodipine is noninferior to nifedipine ER in managing hypertension in the postpartum period.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Amlodipine intervention 2: NIFEdipine ER
Intervention descriptions: intervention 1: Initiation of amlodipine 2.5 mg intervention 2: Initiation of nifedipine ER 30 mg

Protocol documents:
Prot_SAP_000.pdf: 
1 
 
PROTOCOL TITLE: Amlodipine versus nifedipine ER for the management of postpartum 
hypertension: A randomized controlled noninferiority trial  
 
Lead Investigator: 
Katelyn Pratt, MD 
Prisma Health/University of South Carolina Greenville 
Version Date: August 8, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


2 
 
TABLE OF CONTENTS 
Table of contents……………...………………………………….………………………………2 
Protocol Synopsis……………………………………………………………………………..….3 
1 
BACKGROUND AND RATIONALE…………………………….………………….5  
2 
STUDY OBJECTIVES………………………………………………………………..7 
3 
INVESTIGATIONAL PLAN…………………………………………………………8 
4 
STUDY PROCEDURES……………………………………………………………...9 
5 
STUDY EVALUATIONS AND MEASUREMENTS………………………………12 
6 
STATISTICAL CONSIDERATIONS……………………………………………….13 
7 
DATA COLLECTION AND MANAGEMENT…………………………………….13 
8 
REFERENECES……………………………………………………………………..13 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


3 
 
PROTOCOL SYNOPSIS 
Study Title 
Amlodipine versus nifedipine ER for the management of postpartum 
hypertension: A randomized controlled noninferiority trial  
Funder 
 Prisma Health OBGYN Departmental Research Fund 
Study Rationale 
-A significant number of pregnancies are complicated by hypertensive 
disorders (chronic hypertension, gestational hypertension, preeclampsia)  
-Hypertension is often exacerbated in the postpartum period 
 
-Many of these patients require initiation of antihypertensives after 
delivery 
 
-There are a limited number of well-studied treatment options routinely 
used (labetalol and nifedipine ER) 
 
-Prior studies have shown that both labetalol and nifedipine ER are 
effective 
 
-Nifedipine ER has few contraindications, but has significantly more side 
effects than labetalol 
 
-Headache is one of the most commonly reported side effects with 
nifedipine ER 
 
-Headache is also a commonly reported symptom of preeclampsia 
 
-Amlodipine is in the same drug class as nifedipine ER, but does not cause 
headaches 
 
-Amlodipine is a first-line antihypertensive in the non-obstetric population 
 
-Amlodipine has not been studied in the obstetric population 
Study Objectives 
Primary 
 
-To evaluate whether amlodipine is noninferior to nifedipine ER in the 
management of postpartum hypertension 
 
Secondary 
 
-To evaluate whether patients tolerate amlodipine better than nifedipine 
ER  
Study Design 
Unmasked, pragmatic randomized controlled trial  
 
 
 


4 
 
Subject Population Inclusion criteria 
 
-English and Spanish-speaking postpartum women with a diagnosis of 
chronic hypertension, gestational hypertension, or preeclampsia 
 
-Delivery at or beyond 20 weeks’ gestation 
 
-Need for antihypertensive therapy, defined as blood pressure >/= 150 
mmHg systolic and/or 100 mmHg diastolic on two occasions four hours 
apart, or one severe blood pressure >160 mmHg systolic and/or 110 
mmHg diastolic. 
 
-Age 18 years or older 
 
Exclusion criteria 
 
-Use of antihypertensives prior to delivery (either for hypertension or 
other indications, i.e. tachycardia) 
 
-Allergy to nifedipine ER or amlodipine 
 
-Persistent tachycardia (as defined by the treatment team) 
Number of Subjects 160 
Study Duration  
Each subject’s participation is expected to last less than 8 weeks 
 
The entire study is expected to last 24 months  
Study phases 
-Screening: Women admitted to Greenville Memorial Hospital Family 
Birthplace will be screened on admission to determine if they have a 
hypertension diagnosis. Additionally, postpartum women on the Women’s 
Specialty unit who do not meet criteria prior to delivery will be rescreened 
once daily. Women with hypertensive diagnoses will be approached about 
their willingness to participate in the study, either at the time of admission 
or at time of diagnosis. 
 
-Randomization: Participants will be randomized to either nifedipine ER 
or amlodipine at the time of enrollment. In order to maximize participant 
capture, all screened patients who have a hypertensive diagnosis and agree 
to study participation will be consented and randomized. Only those who 
progress to needing antihypertensives will meet full inclusion criteria and 
ultimately be enrolled in the study.  
 
-Intervention: Those participants meeting inclusion criteria for 
antihypertensives will be administered the study medication. Participants 
will be administered either amlodipine or nifedipine ER, depending on 
their treatment arm allocation. 


5 
 
 
-Follow-up: Data regarding the patient’s need for additional medications, 
side effects, and length of stay will be collected throughout the 
hospitalization. Patients will attend a blood pressure check visit ideally 3 
to 7 days after hospital discharge (virtual (for patients with home blood 
pressure cuff only) or in-person) and a postpartum visit ideally 4-6 weeks 
after delivery (in person), per standard of care. Additional data will be 
collected at these visits.  
Safety Evaluations While hospitalized, patients will be monitored daily by the clinical team to 
assess for side effects and ensure adequate blood pressure control. 
Adjustments will be made by the clinical team as indicated based on 
patient status. After hospital discharge, patients will be able to call the 
office with any concerns and additional appointments for evaluation can 
be made as necessary.  
Statistical and  
Noninferiority of amlodipine will be assessed with Wilcoxon Rank-Sum                            
Analytic Plan  
 
 
Data and Safety  
Participants will be provided with contact information for the PI should      
Monitoring Plan       they have any concerns.  
 
1     BACKGROUND AND RATIONALE 
Hypertensive disorders of pregnancy are a major cause of maternal morbidity and mortality, and 
it is felt that at least a portion of these adverse outcomes are preventable1. Worldwide, between 2 
and 8 percent of pregnancies are complicated by preeclampsia2. Additionally, 0.9 to 1.5 percent 
of pregnant women have pre-existing chronic hypertension3. Postpartum hypertension can either 
be due to an exacerbation of existing chronic hypertension or preeclampsia, or it can be new 
onset2,4. Blood pressures tend to increase in the postpartum period, peaking at three to six days 
postpartum. It is not uncommon for women who did not require medications during the 
pregnancy to be started on an antihypertensive in the postpartum period3,5. If blood pressures are 
greater than or equal to 150 mmHg systolic and/or 100 mmHg diastolic on two occasions four to 
six hours apart, antihypertensive therapy is recommended4,6,7.  


6 
 
 
The most commonly used antihypertensive medications in the postpartum period are 
labetalol and nifedipine ER. Studies have shown that nifedipine ER is at least as effective, and 
potentially even more effective, than labetalol in achieving blood pressure control4,7. However, 
significantly more patients have side effects when taking nifedipine ER (48% versus 20%), and 
24% of women using nifedipine ER report headache as a side effect7. Headache is a known 
symptom of preeclampsia, and its presence as a symptom can change patient management. When 
patients are using nifedipine ER, it can be difficult to determine if the headache is due to the 
medication or the disease, making management decisions difficult.  
 
Like nifedipine ER, amlodipine is a dihydropyridine calcium channel blocker8. Headache 
is not a commonly reported side effect of amlodipine. Amlodipine is not commonly used in the 
postpartum setting, but a prior study in the non-obstetrical population demonstrated that 
amlodipine and nifedipine ER resulted in comparable reductions in blood pressure and can be 
considered equivalent. Amlodipine was also found to have a significantly lower rate of side 
effects than nifedipine ER (27% versus 41%)9.   
 
Nifedipine ER is considered safe in breastfeeding women. Typically, a relative infant 
dose (RID) less than 10% is considered safe, and nifedipine ER has a RID of 2.3%. There is 
limited data on amlodipine use in breastfeeding women, and therefore the LactMed Database 
currently recommends an alternative to amlodipine if possible. However, one study has shown 
that the median RID for amlodipine is 4.18%, suggesting it is safe to use in breastfeeding 
women. In addition, multiple case reports of breastfeeding mothers using amlodipine did not 
demonstrate any adverse effects in the infant10. Although further data should continue to be 
collected, these prior studies and case reports are reassuring.   


7 
 
 
We hypothesize that amlodipine will be as effective as nifedipine ER in controlling blood 
pressures in patients with postpartum hypertension, as reflected by equivalent times from 
delivery to hospital discharge. In addition, we hypothesize that women taking amlodipine will 
report fewer side effects than those taking nifedipine ER. No effects on breastfeeding outcomes 
are expected.  
1.1 
Description of Intervention 
Amlodipine and nifedipine ER are both dihydropyridine calcium channel blockers. In women 
with hypertensive disorders who meet criteria for initiation of treatment as outlined above, the 
allocated treatment will be initiated by the inpatient clinical team. The recommended starting 
dose for nifedipine ER will be 30 mg daily and the recommended starting dose for amlodipine 
will be 2.5 mg daily. Doses will be adjusted as needed by the clinical team. Patients will be 
treated with additional short-acting antihypertensives, additional long-acting 
antihypertensives or intravenous magnesium for seizure prophylaxis as would otherwise be 
clinically indicated.  
2 
STUDY OBJECTIVE 
2.1 
Primary Objective 
The primary hypothesis of this study is that amlodipine is noninferior to nifedipine ER in the 
management of postpartum hypertension, as evidenced by length of stay from delivery until 
hospital discharge. A noninferiority limit of 24 hours was selected as a clinically relevant 
difference.  
2.2.     Secondary Objective 
Secondary outcomes include the need for additional antihypertensive medications (either 
increased dose, additional long-acting agents, or additional short-acting agents), patient-


8 
 
reported side effects, medication discontinuation due to side effects, hospital readmissions, 
duration of breastfeeding, and breastfeeding continuation and satisfaction.  
3 
INVESTIGATIONAL PLAN 
3.1 
Study Design 
This is an unmasked, pragmatic randomized controlled trial.  
Women randomized to arm 1 will be started on amlodipine 2.5 mg daily. Women randomized 
to arm 2 will be started on nifedipine ER 30 mg daily. Dose adjustments will be made as 
deemed appropriate by the clinical team. Intravenous magnesium, additional long-acting 
antihypertensives, and short-acting antihypertensives will be administered as deemed 
appropriate by the clinical team. Women will be discharged from the hospital when the team 
feels that all discharge criteria have been met. While each provider may use slightly different 
discharge criteria based on their practice patterns, it is agreed upon that no patient will be 
discharged until her blood pressure is < 160/110 mmHg. They will be scheduled for a blood 
pressure check (virtual or in-person) ideally 3 to 7 days after discharge and an in-person visit 
ideally at 4 to 6 weeks postpartum. Participation in the study will not affect usual 
management aside from medication assignment.  
3.2 
Allocation to Treatment Groups and Blinding (if applicable) 
A computer-generated randomization schedule with 1:1 allocation will be utilized. 
Randomization will occur at time of study enrollment utilizing REDCap. Randomization will 
be stratified by chronic hypertension diagnosis status. The research staff will be responsible 
for accessing the centralized randomization system, obtaining patient allocation, and notifying 
the treatment team of patient assignment. 
3.3 
Study Duration, Enrollment, and Number of Subjects 


9 
 
Study duration for each participant will last less than 8 weeks (enrollment during initial 
hospitalization through postpartum visit). 160 patients will be enrolled. This is anticipated to 
take approximately 18 months.  
3.4 
Study Population 
English and Spanish-speaking postpartum women, who delivered at or beyond 20 weeks’ 
gestation, with a diagnosis of chronic hypertension, gestational hypertension, or preeclampsia 
requiring initiation of antihypertensives.  
Exclusion criteria: Use of antihypertensives antepartum, allergy to nifedipine or amlodipine, 
persistent tachycardia (as defined by treatment team). 
4 
STUDY PROCEDURES 
4.1 
Screening procedure 
Women will initially be screened for study participation at the time of admission to Greenville 
Memorial Hospital’s Family Birthplace unit. Additionally, women who do not initially meet 
criteria will be rescreened daily for the development of a new hypertension diagnosis. Women 
will be consented for enrollment and randomized at the time of admission or at time of diagnosis 
to ensure maximum trial participation. Not all women who are initially consented will meet 
criteria for final inclusion in the study and initiation of the study drug. Based on review of 
historical data, approximately 50% of patients who meet diagnostic criteria will eventually meet 
criteria for medication administration.  
4.2 
Intervention 
Once a woman meets inclusion criteria for antihypertensives, she will be administered the 
appropriate study drug. Randomization will have already occurred at the time of enrollment so 
that there will not be a delay in patient treatment while awaiting randomization. Randomization 


10 
 
will not be blinded. Women in group 1 will be started on amlodipine 2.5 mg daily and women in 
group 2 will be started on nifedipine ER 30 mg daily. Aside from the study drug assignment, the 
remainder of the patient’s postpartum care will be performed according to the clinical team’s 
discretion. Study flow is described in the below figure.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


11 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient screened for hypertensive 
disorder on admission to Family 
Birthplace Unit
Patient has a hypertension diagnosis, 
approached about study enrollment 
Interested women consented and 
randomized 
Patient meets criteria for 
antihypertensive initiation 
Group 1:  
Amlodipine 
2.5 mg daily 
started 
Group 2:  
Nifedipine ER 
30 mg daily 
started 
Medications adjusted as needed by 
treatment team  
Patient eligible for hospital discharge. 
Side effect questionnaire completed. 
Data from hospital chart abstracted 
Postpartum blood pressure check 
ideally 3-7 days after discharge 
Postpartum visit ideally 4-6 weeks 
after delivery. Breastfeeding 
questionnaire completed 
Patient does not have a hypertension 
diagnosis 
Patient rescreened daily until hospital 
discharge 
Patient meets criteria for 
hypertensive diagnosis, approached 
about study enrollment 


12 
 
4.3 
Subject Completion/Withdrawal procedures  
Participants are instructed to inform their enrolling research personnel if they desire to withdraw 
from the study, at which point participation will be terminated.  
5 
STUDY EVALUATIONS AND MEASUREMENTS 
-Demographic characteristics and clinical data will be abstracted from the medical chart 
 
-Maternal age 
 
-Gestational age at delivery 
 
-Race 
 
-BMI 
 
-Parity 
 
-Mode of delivery 
 
-Hypertensive diagnosis 
 
-History of diabetes (gestational or pre-gestational) 
-Length of stay from delivery until discharge 
-Number of acute antihypertensive treatments 
-Number of dose increases of initial study drug 
-Number of additional long-acting antihypertensives started 
-Magnesium use 
-Side effects reported 
-Medication discontinuation 
-Discharging physician 
-Blood pressure at blood pressure check appointment 
-Blood pressure at postpartum visit 


13 
 
-Readmissions from time of discharge until postpartum visit 
-Breastfeeding status at time of postpartum visit 
-Patient-reported length of breastfeeding 
-Patient-reported breastfeeding satisfaction  
6 
STATISTICAL CONSIDERATION 
6.1 
Sample size calculation 
An initial power calculation was performed using a standard deviation of 55.2 hours and a non-
inferiority limit of 24 hours; to achieve 80% power with a 2-tailed alpha of 0.05, 66 women 
would be needed in each arm. 
7 
DATA COLLECTION AND MANAGEMENT  
Data will be entered directly from the medical record into the REDCap data management system 
for storage and access for statistical analysis by the primary investigator.  
8 
REFERENCES  
1. Hypertension in pregnancy: Executive summary. (2013). Obstetrics and 
Gynecology, 122(5), 1122-1131. 
2. ACOG practice bulletin no. 222: Gestational hypertension and preeclampsia. 
(2019). Obstetrics and Gynecology, 133(1), e1-e25. 
doi:10.1097/AOG.0000000000003018 [doi] 
3. American College of Obstetricians and Gynecologists' Committee on Practice 
Bulletins—Obstetrics. (2019). ACOG practice bulletin no. 203: Chronic hypertension in 
pregnancy. Obstetrics and Gynecology, 133(1), e26-e50. 
doi:10.1097/AOG.0000000000003020 [doi] 


14 
 
4. Ainuddin, J., Javed, F., & Kazi, S. (2019). Oral labetalol versus oral nifedipine for the 
management of postpartum hypertension a randomized control trial. Pakistan Journal of 
Medical Sciences, 35(5), 1428-1433. doi:10.12669/pjms.35.5.812 [doi] 
5. Magee, L., & von Dadelszen, P. (2013). Prevention and treatment of postpartum 
hypertension. The Cochrane Database of Systematic Reviews, (4):CD004351. doi(4), 
CD004351. doi:10.1002/14651858.CD004351.pub3 [doi] 
6. Cairns, A. E., Pealing, L., Duffy, J. M. N., Roberts, N., Tucker, K. L., Leeson, P., et al. 
(2017). Postpartum management of hypertensive disorders of pregnancy: A systematic 
review. BMJ Open, 7(11), e018696-2017-018696. doi:10.1136/bmjopen-2017-018696 
[doi] 
7. Sharma, K. J., Greene, N., & Kilpatrick, S. J. (2017). Oral labetalol compared to oral 
nifedipine for postpartum hypertension: A randomized controlled trial. Hypertension in 
Pregnancy, 36(1), 44-47. doi:10.1080/10641955.2016.1231317 [doi] 
8. Bloch, M. (2020). In Basile J. (Ed.), Major side effects and safety of calcium channel 
blockers. UpToDate. 
9. Hosie, J., Bremner, A. D., Fell, P. J., James, I. G., Saul, P. A., & Taylor, S. H. (1992). 
Comparison of early side effects with amlodipine and nifedipine retard in 
hypertension. Cardiology, 80 Suppl 1, 54-59. doi:10.1159/000175048 [doi] 
10. Naito, T., Kubono, N., Deguchi, S., Sugihara, M., Itoh, H., Kanayama, N., et al. (2015). 
Amlodipine passage into breast milk in lactating women with pregnancy-induced 
hypertension and its estimation of infant risk for breastfeeding. Journal of Human 
Lactation: Official Journal of International Lactation Consultant Association, 31(2), 
301-306. doi:10.1177/0890334414560195 [doi] 

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CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
 
Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized 
Controlled Noninferiority Trial 
 
Study to be Conducted at: 
Greenville Memorial Hospital 
 
 
 
 
701 Grove Road 
 
 
 
 
Greenville, South Carolina 29605 
 
Prisma Health OB/GYN Center 
 
 
 
 
1120 Grove Road Suite B 
 
 
 
 
Greenville, South Carolina 29605 
 
Sponsor Name: 
 
Prisma Health 
 
Principal Investigator:  
Laura Carlson, MD  
864-455-1600 
 
KEY INFORMATION 
You are being asked to participate in a research study. Participation in a research study is voluntary. The 
information in this consent form is meant to better inform you so you may decide whether or not to 
participate in this research study. Please ask the study doctor to explain anything you do not understand.  
 
Many pregnancies are affected by high blood pressure. Women can be diagnosed with different categories 
of high blood pressure. Your doctor may have diagnosed you with chronic hypertension (high blood 
pressure even outside of pregnancy), gestational hypertension (high blood pressure only during 
pregnancy), or preeclampsia (high blood pressure during pregnancy plus other signs and symptoms). While 
many forms of high blood pressure improve after delivery, blood pressure usually increases before 
improving. Many women need to start blood pressure medication after delivery. 
 
This study will compare two different blood pressure medications to be used after delivery, amlodipine and 
nifedipine ER. The purpose of this study is to compare the effects (good and bad) of amlodipine and 
nifedipine ER on your blood pressure to see which is better. 
 
This research study is being done because there are currently limited recommended treatment options for 
managing high blood pressure in postpartum women. It is known that amlodipine and nifedipine ER are 
both effective in managing high blood pressure in the general population, but amlodipine has not been well-
studied for high blood pressure during pregnancy and immediately after delivery. 
 
The risks of the study are that amlodipine is ineffective in managing postpartum hypertension and that it 
may have an unknown adverse effect on breastfeeding. The potential benefit is that amlodipine is at least 
as effective as nifedipine ER and that it causes less side effects.  
 
If you choose not to participate in this study and need medications, you will be started on a medication 
which your doctor chooses based on your particular case (which may include amlodipine or nifedipine ER). 
Aside from the choice of medication, you will have no other changes in your care. You will have 
medications added or adjusted as needed and be discharged from the hospital when your doctor feels it is 
 
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appropriate. You will follow up in the clinic at the same time regardless of study participation (ideally 3 to 7 
days after discharge and 6 weeks postpartum).  
 
The Institutional Review Board of the Prisma-Health Upstate has reviewed this study for the protection of 
the rights of human participants in research studies, in accordance with federal and state regulations. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This website will not include information that can identify you. At most, the Web site will include a summary 
of the results. You can search this website at any time. 
 
PURPOSE 
You are being asked to participate in this study because you have high blood pressure following delivery of 
your baby.  
 
Right now, there are 2 main medications used to treat high blood pressures in women who are immediately 
postpartum (labetalol and nifedipine ER). Both of these medications are safe and effective, but they are not 
right for everyone. There are many other medications used to treat high blood pressure in patients who 
have not recently had a baby. Because these medications have not been specifically studied in postpartum 
women, their use has been limited. One of these medications is called amlodipine. Amlodipine is a similar 
medication to nifedipine ER, but studies have shown it causes less side effects. It is one of the first-choice 
blood pressure medications in non-pregnant patients because it is effective and well tolerated. The purpose 
of this study is to see if amlodipine is a good treatment option for women in the immediate postpartum 
period. This study will compare the use of nifedipine ER to amlodipine to see if they have similar outcomes. 
If amlodipine is as effective as nifedipine ER, it may provide a good treatment alternative for patients with 
high blood pressures following delivery.  
 
The risks of the study are that amlodipine has not been well-studied for this purpose. If it is not as effective 
as nifedipine ER, you may require additional medications, a change in medications, or a longer stay in the 
hospital while your medications are being adjusted. In addition, amlodipine is not well studied in 
breastfeeding women. If you choose to participate in this study and your blood pressure is high enough that 
you need started on medications, you will be randomly assigned either to amlodipine or nifedipine ER. This 
medication may later be discontinued by your doctor if your blood pressure improves. 
 
Your participation will last until your postpartum visit is completed at about 6 weeks after delivery. 
 
This study is being conducted as part of the thesis requirements of the Prisma Health Maternal-Fetal 
Medicine Fellowship program.  
 
HOW THE STUDY WORKS 
• Nifedipine ER is a standard medication used for managing high blood pressure in postpartum 
women. 
• Amlodipine is a standard blood pressure medication in the general population. Its use for high 
blood pressure specifically in postpartum women is investigational. 
• Both nifedipine ER and amlodipine are approved by the Food and Drug Administration (FDA). 
• If you are not enrolled in the study, your blood pressure will still be treated with the medication your 
doctor feels best (typically nifedipine ER or labetalol, although others may be used). 
 
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• If you agree to participate, you will be “randomized” into one of the study groups. Randomization 
means that you are put into a group by chance. It is like flipping a coin. Neither you nor your doctor 
will choose what group you will be in. You will have an equal chance of being placed in either 
group. 
• The study will not be blinded, meaning that you and your medical team will know which medication 
you are taking. 
• When your blood pressure is high enough to need medications (>/= 150 mmHg systolic and/or 100 
mmHg diastolic on two occasions 4 hours apart, or one severe blood pressure of >160 mmHg 
systolic and/or 110 mmHg diastolic), your doctor will start you on the assigned study medication. 
• You will be started on the lowest recommended medication dose initially – either amlodipine 2.5 
milligram (mg) daily or nifedipine ER 30 mg daily. 
• Your doctor will increase your medication dose if needed. Your doctor may also treat you with 
additional blood pressure medications or magnesium, depending on the need. 
• When your doctor feels you are ready, you will be discharged home. 
• Prior to being discharged from the hospital, you will be asked to complete a side effects 
questionnaire.  If a side effects survey is not completed prior to discharge, study staff may call you 
to administer the questions over the phone or ask you to complete the questionnaire at your next 
scheduled appointment. 
• You will be seen (either virtually or in-person) for a blood pressure check ideally 3 to 7 days after 
hospital discharge. Your blood pressure will be assessed at that time and your doctor will decide if 
you should continue medications. 
• You will be seen in-person ideally 4 to 6 weeks after delivery. Your blood pressure will be assessed 
at that time and your doctor will decide if you should continue medications. You will also be asked 
to complete a form about your breastfeeding experiences.  If this breastfeeding survey is not 
completed at your visit, study staff may send a survey link to your email or call you in person to 
administer the questions over the phone.   
 
POSSIBLE RISKS 
Any treatment has possible side effects. The treatments and procedures used in this study may cause all, 
some, or none of the side effects listed. There is always the risk of very uncommon or previously unknown 
side effects. 
 
The most common side effects for Nifedipine include headache, flushing, dizziness, weakness, and 
nausea.   
 
The most common side effects for Amlodipine include swelling, dizziness, flushing, irregular heartbeat, 
fatigue, nausea, abdominal pain, and headache.  
  
The side effects listed above do not include all the possible side effects that can occur from taking these 
medications, and there are other less common or rare side effects that may occur.  If you are interested in a 
complete list of known side effects, this can be requested from the study investigator.  It is important to let 
your physician know of any possible side effects that you experience as some of these complications can 
sometimes lead to serious illness requiring hospitalization or lead to death. 
 
As with all medications, side effects may include allergic reactions. Allergic reactions may range from minor 
itching or rash to major reactions, which can lead to death. 
 
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Some of the questions in the survey are personal and may be upsetting to some participants. The study 
doctor or staff will be available to discuss these questions should you have a concern or problem. You do 
not have to answer any questions that you do not want to answer. 
 
It is possible that receiving the study drug with your regular medications, supplements, or some food (for 
example, grapefruit juice) may change how the study drug, your regular medications, or your regular 
supplements work. It is very important that you tell the study doctor about all medications or supplements 
you are taking during the study. Tell the study doctor if you are taking any drugs, or non-prescription 
medications or supplements, including vitamins or herbs, other than those being used in this research study 
because of the risk of possible and/or serious drug interactions. Tell anyone who gives you medical care 
that you are participating in a research study. 
 
POSSIBLE BENEFITS 
It is not possible to know whether or not you may benefit from participating in this study. The treatment or 
procedures you receive may even be harmful. The information gained from this study may be useful and 
may help others. 
 
The particular benefits of receiving the study medication (amlodipine) are uncertain. Potential individual 
benefits include a shorter hospital stay and less side effects.  
 
If the study medication (amlodipine) is found to be as good as nifedipine ER at managing high blood 
pressure in postpartum patients, other patients may benefit from this information in the future, since it will 
give doctors and patients additional treatment options.  
 
ALTERNATIVE (OTHER) TREATMENTS 
You can still receive evaluation and treatment for your condition if you do not participate in this study.  
Discuss any alternative treatments with your regular doctor and/or the study doctor before you decide to 
participate.  The decision is entirely up to you.  If you decide not to participate in the study, you will not be 
penalized or lose any benefits and your decision will not affect your relationship with your doctor or hospital. 
 
Standard of care for patients with high blood pressure following delivery is to start medications when the 
blood pressure is greater than or equal to 150 mmHg systolic and/or 100 mmHg diastolic on 2 occasions 4 
hours apart. Nifedipine ER and labetalol are the routinely used medications. If you do not participate in this 
study and your doctor feels that you need blood pressure medications, they will choose one that they feel is 
appropriate.  
 
• You may choose to have the standard of care treatment, which is typically nifedipine ER or 
labetalol. 
• You may choose to take part in a different research study, if one is available.  
• You may choose not to be treated. 
 
Please discuss these choices with your doctor. 
 
 
 
 
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NEW INFORMATION 
Your doctor will tell you about new information that may affect your willingness to participate in this 
research study. Alternatives, or other choices, concerning your care will be discussed at that time.  
 
There are no plans to share individual research results with you.  
 
COST TO YOU FOR PARTICIPATING IN THIS STUDY 
All of the tests and procedures in this study are considered part of your routine care and will not be paid for 
by the study. We will bill you or your health insurer for these routine items and services, which you would 
have received even if you did not take part in the research. You will be responsible for payment of any 
deductible and copayments required by your insurer.  
 
If you have any question about costs to you that may result from taking part in the research, please speak 
with the study doctor or staff.  
 
PAYMENT FOR PARTICIPATION  
To You: 
You will not be paid for participating in this study, but you will be given a pack of diapers for your 
participation. 
 
To Institution:  
Prisma-Health Upstate is being funded by the sponsor for staff and administrative costs associated with 
conducting this study. 
 
COMPENSATION FOR INJURY AS A RESULT OF STUDY PARTICIPATION 
Prisma-Health Upstate will provide you the care needed to treat any injury, or illness, that directly results 
from taking part in this research study.   
 
Injuries sometimes happen in research even when no one is at fault. The study sponsor, Prisma-Health 
Upstate, or the investigators as part of this study have no plans to pay you or give you other compensation 
for an injury, should one occur. However, you are not giving up any of your legal rights by signing this form.  
 
If you think you have been injured or have experienced a medical problem as a result of taking part in this 
research study, tell the person in charge of this study as soon as possible. The researcher’s name and 
phone number are listed in the ‘Contact for Questions’ section of this consent.  
 
VOLUNTARY PARTICIPATION 
Participation in this research study is voluntary. You may refuse to participate or withdraw from the study at 
any time. If you refuse to participate or withdraw from the study, you will not be penalized or lose any 
benefits and your decision will not affect your relationship with your doctor or hospital. 
 
However, if you decide to stop study participation, you are encouraged to talk with your doctor regarding 
safe removal from the study. Further treatment would be discussed. 
 
If your participation in this research study is stopped, your study doctor will discuss any tests or procedures 
that might be needed for your health and safety, but you may refuse any or all of these tests or procedures.  
 
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Following this discussion with your study doctor, you still have the right to refuse any or all of these tests or 
procedures. 
 
Sudden withdrawal from the study without starting a different medication for your blood pressure may result 
in very high blood pressures, which can be dangerous. The consequences of very high blood pressure can 
include stroke and even death. You should talk to your doctor before stopping a blood pressure medication.  
 
AUTHORIZATION TO USE AND DISCLOSE (RELEASE) MEDICAL INFORMATION 
As part of this research study, the study doctor and his/her research team will keep records of your 
participation in this study. These study records may be kept on a computer and will include all information 
collected during the research study, and any health information in your medical records that is related to the 
research study. The study doctor and his/her research team will use and disclose (release) your health 
information to conduct this study. This study may result in scientific presentations and publications, but 
steps will be taken to make sure you are not identified.   
 
Some of the organizations/entities that may receive your information are: 
• The study sponsor and any company supporting the study (the sponsor’s authorized 
representatives) 
• The Institutional Review Board, which is a group of people who review research with the goal of 
protecting the people who take part in the study 
 
Under federal privacy laws, your study records cannot be used or released for research purposes unless 
you agree. If you sign this consent form, you are agreeing to the use and release of your health information. 
If you do not agree to this use, you will not be able to participate in this study.  Once your health information 
has been released, federal privacy laws may no longer protect it from further release and use.  
 
The right to use your health information for research purposes does not expire unless you withdraw your 
agreement. You have the right to withdraw your agreement at any time. You can do this by giving written 
notice to the study doctor. If you withdraw your agreement, you will not be allowed to continue participation 
in this research study. However, the information that has already been collected will still be used and 
released as described above. You have the right to review your health information that is created during 
your participation in this study. After the study is completed, you may request this information. 
 
If you have any questions about the privacy of your health information, please ask the study doctor. 
 
 
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CONTACT FOR QUESTIONS 
For more information concerning this study and research-related risks or injuries, or to give comments or 
express concerns or complaints, you may contact the principal investigator, whose information is included 
below. 
 
You may also contact a representative of the Office of Human Research Protection of Prisma-Health 
Upstate for information regarding your rights as a participant involved in a research study or to give 
comments or express concerns, complaints or offer input. You may obtain the name and number of this 
person by calling (864) 455-8997. 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator Name: Laura Carlson, MD 
 
 
Telephone Number: 864-455-1600 
 
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CONSENT TO PARTICIPATE 
The study doctor, ____________________________________________, has explained the nature and 
purpose of this study to me. I have been given the time and place to read and review this consent form and 
I choose to participate in this study.  I have been given the opportunity to ask questions about this study 
and my questions have been answered to my satisfaction. I have been given the opportunity to review my 
study doctor’s Notice of Privacy Practices. I agree that my health information may be used and disclosed 
(released) as described in this consent form. After I sign this consent form, I will receive a copy of it for my 
own records. I do not give up any of my legal rights by signing this consent form. 
 
 
_____________________________________________ 
Printed Name of Participant 
 
 
_____________________________________________   
_____________ 
____________ 
Signature of Participant  
 
 
 
 
Date 
 
 
Time 
 
INVESTIGATOR STATEMENT 
I have carefully explained to the participant the nature and purpose of the above study. The participant 
signing this consent form has (1) been given the time and place to read and review this consent form; (2) 
been given an opportunity to ask questions regarding the nature, risks and benefits of participation in this 
research study; and (3) appears to understand the nature and purpose of the study and the demands 
required of participation. The participant has signed this consent form prior to having any study-related 
procedures performed. 
 
_______________________________________________ 
_______________ 
___________ 
Signature of Investigator  
 
 
 
 
Date 
 
 
Time 
 
Principal Investigator: 
Laura Carlson, MD 
 
Phone 864-455-1600 
                                                                                             
Co-Investigators: 
                                                     Phone 864-455-1600                      
 
Bobbie Blake, MD 
Jill Boland, MD 
Baylee Brown, DO 
Valerie Cacciatore, DO 
Mark Calaway, MD 
Erin Casey, MD 
Judy Chen, MD 
Amy Crockett, MD 
Meghan DuBose, MD 
Nathan Gilreath, MD 
 
 
 
 
 
 
Laura Gorham, MD 
Natalie Green, MD 
Eliza Hardy, MD 
Felicia Headley, MD 
May Hester, DO 
Lauren Jones, MD 
Alison Kimura, MD 
Kelly Little, MD 
Adair London, MD 
Ross Lordo, MD 
 
 
 
 
 
 
Kristine Martin, MD 
Isabella Mateu, MD 
Jennifer Palomo, MD 
Kate Pratt, MD 
Alison Sansone, MD 
Kayle Sessions, MD 
Clay Southern, MD 
Bryson Wightman, DO 
Melissa Wise, MD 
 
 
 
 
 
 
Prisma Health
Date Approved: August 26, 2022
Reference Number: 1853026-4
Date Expires: February 9, 2023