Hypertension
Conditions
Brief summary
Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and deliver an infant via vaginal delivery will be placed into two groups in the postpartum period. One group will receive Ibuprofen for pain control and the other group will be given Tylenol. Blood pressures during the postpartum period will then be collected and compared in order to see if NSAIDs use increases blood pressure.
Detailed description
The patients who have a vaginal delivery and have the diagnosis of hypertension in pregnancy will be randomized to either Ibuprofen use or acetaminophen use during the postpartum period. Standard blood pressure monitoring in the postpartum period will be followed to help determine if there is a significant rise in the women who use NSAIDS in the postpartum period versus those that use acetaminophen. Groups will be divided into women with chronic hypertension, women with chronic hypertension with superimposed preeclampsia, women with preeclampsia without severe features, women with preeclampsia with severe features, women with gestational hypertension without severe range blood pressures, and women with gestational hypertension with severe range blood pressures. Recruitment will last 36 months. Patients will be monitored during their postpartum stay (typical 2 days) with blood pressure measurements. An additional 12 months will be needed for data analysis and publication.
Interventions
DRUGAcetaminophen
Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
DRUGNSAID
Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
Sponsors
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* vaginal delivery * diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia * preeclampsia without severe features * preeclampsia with severe features gestational hypertension without severe range blood pressures * gestational hypertension with severe range blood pressures * singleton pregnancies
Exclusion criteria
* Cesarean Delivery * no diagnosis of hypertensive disorder * chronic or acute renal disease * allergy to ibuprofen or acetaminophen * lupus * multiple order pregnancies (twins, triplets) * Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2. | 2 days | To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing systolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of systolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of systolic blood pressures from 24 hours to 47 hours after delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2. | 2 days | To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing diastolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of diastolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of diastolic blood pressures from 24 hours to 47 hours after delivery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acetaminophen Women receiving acetaminophen for primary pain control following vaginal delivery. | 16 |
| NSAID Women receiving Ibuprofen for primary pain control following vaginal delivery. | 20 |
| Total | 36 |
Baseline characteristics
| Characteristic | Acetaminophen | NSAID | Total |
|---|---|---|---|
| Age, Continuous | 28 years | 25 years | 27 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 20 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 16 Participants | 20 Participants | 36 Participants |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 20 |
| other Total, other adverse events | 0 / 16 | 0 / 20 |
| serious Total, serious adverse events | 0 / 16 | 0 / 20 |
Outcome results
Primary
Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing systolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of systolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of systolic blood pressures from 24 hours to 47 hours after delivery.
Time frame: 2 days
Population: Mean difference day 1 compared to day 2 of systolic blood pressure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen | Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2. | 7.5 mmHg | Standard Deviation 13.8 |
| NSAID | Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2. | 5 mmHg | Standard Deviation 6.1 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing diastolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of diastolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of diastolic blood pressures from 24 hours to 47 hours after delivery.
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen | Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2. | 0.4 mmHg | Standard Deviation 11.1 |
| NSAID | Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2. | 2.7 mmHg | Standard Deviation 7.1 |