Clinical trial NCT03026673: Retrospective Review of NSAIDS in the Postpartum Period
Official title: Hypertension and NSAIDS in the Postpartum Period
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Post Partum Pain
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant, All ethnic backgrounds will be included.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* received NSAIDs post delivery for pain

Exclusion Criteria:

-

Primary outcomes:
measure: pain relief
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Jennifer Goldkamp, MD
role: PRINCIPAL_INVESTIGATOR
References: