Trial Outcomes & Findings for NSAID Use in Postpartum Hypertensive Women (NCT NCT02902172)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

2 days

Results posted on

2018-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Acetaminophen Women receiving acetaminophen for primary pain control following vaginal delivery.	NSAID Women receiving Ibuprofen for primary pain control following vaginal delivery.
Overall Study STARTED	16	20
Overall Study COMPLETED	16	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NSAID Use in Postpartum Hypertensive Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetaminophen n=16 Participants Women receiving acetaminophen for primary pain control following vaginal delivery.	NSAID n=20 Participants Women receiving Ibuprofen for primary pain control following vaginal delivery.	Total n=36 Participants Total of all reporting groups
Age, Continuous	28 years n=5 Participants	25 years n=7 Participants	27 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days

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

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.

Outcome measures

Outcome measures
Measure	Acetaminophen n=16 Participants Patients will be monitored for change in blood pressure Acetaminophen: Blood pressure will be monitored during postpartum stay (typical 2 days)	NSAID n=20 Participants 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)
Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.	7.5 mmHg Standard Deviation 13.8	5 mmHg Standard Deviation 6.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acetaminophen n=16 Participants Patients will be monitored for change in blood pressure Acetaminophen: Blood pressure will be monitored during postpartum stay (typical 2 days)	NSAID n=20 Participants 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)
Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.	0.4 mmHg Standard Deviation 11.1	2.7 mmHg Standard Deviation 7.1

Adverse Events

Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NSAID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Goldkamp

St. Louis University

Phone: 3149772200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place