This phase 3 trial will investigate the effectiveness of hydrochlorothiazide (HCTZ) for hypertension in postpartum (after giving birth) women (PPW). The main outcomes will be the hospitalization rate (HR) and additional antihypertensive (AHT) requirements.
The details
Hypertension (HT) or high blood pressure (BP) is a serious medical condition. Hypertension is also very dangerous in pregnant women. It can have serious effects on both the fetus and mother. It can even lead to premature death. Pre-eclampsia (PE) and gestational hypertension (GHT) are hypertensive disorders (HTDs) during pregnancy. Some women may find that high BP persists after giving birth. It is important that BP levels are managed after childbirth. Hydrochlorothiazide (HCTZ) is a drug used to reduce BP. It is a diuretic. It reduces blood pressure by increasing the amount of fluid that is eliminated through urine. This reduces blood volume and BP.
This trial will investigate the effectiveness of HCTZ for hypertension in PPW. The main outcomes will be the HR and AHT requirements.
Who are they looking for?
This study will recruit 612 women. As this study begins immediately after childbirth, pregnant women will be recruited to the trial. Participants must have a diagnosis of GHT or PE during pregnancy, labor or post-partum (after delivery).
Patients cannot take part in the trial if they are taking AHTs. Patients that cannot safely take HCTZ are excluded from the trial. Other exclusion criteria include lactose intolerance, pre-pregnancy diabetes.
How will it work
Women will be randomly assigned to receive HCTZ or placebo treatment. The first dose will be taken shortly after childbirth. Women will take HCTZ (50 mg) or placebo once daily for 14 days. Participants will be monitored for 6 weeks in total.
The main outcomes will be the HR and AHT requirements.
