Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03026673 |
| Other study ID # |
26975 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
January 18, 2017 |
| Last updated |
November 8, 2017 |
| Start date |
January 18, 2017 |
| Est. completion date |
April 2019 |
Study information
| Verified date |
November 2017 |
| Source |
St. Louis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Chart review of women who have delivered an infant in a single health care system to
determine if NSAID use increases blood pressures in the postpartum period.
Description:
Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most common medication used for pain
relief in the postpartum period in the United States. For pain relief of uterine involution,
NSAIDs have shown to be superior to placebo, and equivalent or superior to narcotics. In 2013
the American College of Obstetricians and Gynecologists (ACOG) discouraged the use of NSAIDs
in women with pre-eclampsia due to concerns for inadvertently increasing blood pressure. This
recommendation is based on non-obstetrics literature, which tended to show a small increase
of blood pressures in patients who use NSAIDS. However the literature is mixed, particularly
on ibuprofen which is the most common NSAID used in the postpartum. Of the two meta-analysis
that are commonly referenced, Pope et al found a decrease of -0.3 (+/- 2.57) mmHg in mean
arterial pressure (MAP) in patients with hypertension treated with ibuprofen, and Johnson et
al identified an average of 5mmHg increase in blood pressure with ibuprofen use. A large
study of 18,325 patients who were treated with NSAIDS or COX-2 inhibitors, found an average
of a 2.1 (+/- 0.5) mmHg increase in blood pressure with ibuprofen administration.
There are two articles available in the obstetrics literature on the topic of NSAIDS in women
with hypertension disorders. The first is by Makis et al, and is a case series of six women,
with discussion of two cases. The explanations of hypertension causes are limited and
possible alternate diagnoses are not discussed (6). The second by Wasden et al is a
retrospective study of women who had the diagnosis of severe hypertension disorders in
pregnancy. The patients were matched 2:1 for women exposed to NSAIDs versus those who did not
receive NSAIDs. MAPs were compared, and there was no difference found between the two groups.
This second study is better designed and is likely representative of the true outcome of
NSAID use in pre-eclamptic women, as the general literature shows a small, non-clinically
significant change in blood pressure readings.
