NSAID Use in Postpartum Hypertensive Women

• Sponsor: St. Louis University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02902172
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.8
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Acetaminophen; Drug: NSAID	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: NSAID Use in Postpartum Hypertensive Women
• Actual Study Start Date: Mar 15, 2017
• Actual Primary Completion Date: Oct 8, 2017
• Actual Study Completion Date: Oct 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Acetaminophen Patients will be monitored for change in blood pressure	Drug: Acetaminophen; 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; Other Names: Tylenol
Other: NSAID Patients will be monitored during their postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements	Drug: NSAID; 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; Other Names: Ibuprofen

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Mary's Health Center	Saint Louis	Missouri	United States	63117

Sponsors and Collaborators

• St. Louis University

Investigators

• Principal Investigator: Jennifer Goldkamp, MD, St. Louis University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 9, 2017

More Information

Publications

None provided.

• Responsible Party: Jennifer Goldkamp, MD, MD, St. Louis University
• ClinicalTrials.gov Identifier: NCT02902172
• Other Study ID Numbers: 26976
• First Posted: Sep 15, 2016
• Last Update Posted: Oct 31, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hypertension; Acetaminophen; Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Acetaminophen	NSAID
Arm/Group Description	Women receiving acetaminophen for primary pain control following vaginal delivery.	Women receiving Ibuprofen for primary pain control following vaginal delivery.
Period Title: Overall Study
STARTED	16	20
COMPLETED	16	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Acetaminophen	NSAID	Total
Arm/Group Description	Women receiving acetaminophen for primary pain control following vaginal delivery.	Women receiving Ibuprofen for primary pain control following vaginal delivery.	Total of all reporting groups
Overall Participants	16	20	36
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	28	25	27
Sex: Female, Male (Count of Participants)
Female	16 100%	20 100%	36 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	16 100%	20 100%	36 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	16 100%	20 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
Description	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

Outcome Measure Data

Analysis Population Description

Mean difference day 1 compared to day 2 of systolic blood pressure

Arm/Group Title	Acetaminophen	NSAID
Arm/Group Description	Patients will be monitored for change in blood pressure Acetaminophen: Blood pressure will be monitored during postpartum stay (typical 2 days)	Patients will be monitored during their postpartum stay (typical 2 days) and then again at 1 week NSAID: Blood pressure will be monitored during postpartum stay (typical 2 days)
Measure Participants	16	20
Mean (Standard Deviation) [mmHg]	7.5 (13.8)	5 (6.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen, NSAID
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen	NSAID
Arm/Group Description	Patients will be monitored for change in blood pressure Acetaminophen: Blood pressure will be monitored during postpartum stay (typical 2 days)	Patients will be monitored during their postpartum stay (typical 2 days) NSAID: Blood pressure will be monitored during postpartum stay (typical 2 days)
Measure Participants	16	20
Mean (Standard Deviation) [mmHg]	0.4 (11.1)	2.7 (7.1)

Adverse Events

Time Frame	6 months
Arm/Group Title	Acetaminophen		NSAID
Arm/Group Description	Women receiving acetaminophen for primary pain control following vaginal delivery.		Women receiving Ibuprofen for primary pain control following vaginal delivery.
All Cause Mortality
	Acetaminophen		NSAID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/20 (0%)
Serious Adverse Events
	Acetaminophen		NSAID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Acetaminophen		NSAID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.