An interventional study of Labetalol and Hydralazine in Hypertension, sponsored by St. Louis University. Withdrawn. Open to female participants aged 14 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by St. Louis University · Not applicable, Interventional, and Treatment
The investigators plan to monitor the central blood pressure in women with severely elevated blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3 different options for blood pressure control, however no one has studied how these medications affect the central pressures, only peripheral blood pressure.
Women will be screened as they come in through the Women's Evaluation Unit or as transfers from outside hospitals to Labor \& Delivery or the Perinatal Special Care Unit (PSCU). All women with severe hypertension (defined as 160/110 or above for 15 minutes or more) will be screened for inclusion and asked to participate in the study. If the woman agrees to participate she will be randomized to one of three groups with the following protocol:
Labetalol Administer 20mg IV labetalol Repeat BP in 10 minutes, if still severe administer 40mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 80mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, if still elevated consider ICU consult Hydralazine Administer 5mg IV hydralazine Repeat BP in 20 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, still elevated administer labetalol 20mg IV Repeat BP in 10 minutes, still elevated administer labetalol 40mg IV and consider ICU consult Nifedipine Administer procardia 10mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer labetalol 40mg IV and consider ICU consult
Administration of medication will be determined by the routine sphygmomanometer blood pressure as that is what the guidelines are based upon.
Women will then have their central arterial pressure and their carotid waveform assessed before administration of medication. The central pressure will be assessed every 5 minutes and carotid waveforms every 10 minutes until blood pressures are \<160/110 for 20 minutes.
Administration of the above medications is standard of care. Randomization to different medications, measuring the central pressure and the carotid waveform is part of the study.
Once the patient's BP stays below 160/110 for 20 minutes their participation in the study will end.
35 studies on the registry are indexed under Hypertensive Crisis; 9 are open to participants now.
Browse Hypertensive Crisis studies →St. Louis University is the lead sponsor of 152 studies on the registry; 17 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
labetalol
Drug: Labetalol
Hydralazine
Drug: Hydralazine
nifedipine
Drug: nifedipine
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
Also known as: Trandate®
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
Also known as: Apresoline
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
Also known as: Procardia
medication recommended by ACOG for severe hypertension
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously
Time frame: 20min from time of first normal blood pressure after intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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St. Louis University