The aim of this clinical trial is to test the effects of non-steroidal anti-inflammatory drugs on blood pressure in women with mild and severe hypertension after pregnancy. For patients with mild hypertension, the main outcome to be investigated is change in blood pressure throughout the study. For patients with severe hypertension, the main outcome is to record the antihypertensive medication received while in hospital. The trial is recruiting in California, USA.
The details
During and after pregnancy, women may experience hypertensive disorders such as eclampsia and preeclampsia. Blood pressure can be severely elevated with these conditions. Pain relief such as non-steroidal anti-inflammatory drugs (NSAIDs) is often required after delivery. NSAIDs have been known to increase blood pressure in non-pregnant adults. If these drugs have the same effect on women after delivery, then alternative therapies for pain relief will be needed.
This study will look at the effect of the NSAID ibuprofen (Motrin) and an alternative called acetaminophen (Tylenol) on blood pressure in women with mild and severe hypertensive disorders after delivery.
Who are they looking for?
This study will recruit 202 women who have been diagnosed with mild or severe hypertensive disorder after pregnancy. This can include gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome (hemolysis, elevated liver function tests, low platelets). Only women who delivered from at least 24 weeks are eligible.
Participants must not have had chronic hypertension or elevated blood pressure before 20 weeks into their pregnancy. Patients with kidney or liver dysfunction, low platelet count, or sensitivity to either drug used are not eligible. Patients should not have taken anticoagulants (blood thinners) and should not have required a blood transfusion after giving birth.
How will it work
Participants will be assigned to one of 4 groups. Patients will be diagnosed as having either mild or severe post-pregnancy hypertension. All patients will then be randomly assigned to receive either acetaminophen or ibuprofen as pain relief. Patients will be observed for an average of 3 days.
A change in blood pressure is the main outcome for patients with mild hypertension. Antihypertensive medication taken during their hospital stay is the main outcome for patients with severe hypertension. Length of hospital stay, side effects and pain assessment will also be recorded for up to 3 days after delivery.
