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Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

ConditionsPostpartum ComplicationMaternal HypertensionHigh Blood Pressure
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLoma Linda University

About this trial

The purpose of this investigator-initiated randomized control trial is to determine whether oral Nifedipine versus oral Labetalol is superior in controlling high blood pressures in the postpartum period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female

Women who develop postpartum hypertension* after delivery of the placenta or chronic hypertensive postpartum women who require medication for blood pressure control.

Postpartum hypertension requiring treatment are defined as systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than or equal to 90mmHg on at least 2 occasions at least 4 hours apart, or systolic blood pressure greater than or equal to 160mmHg or diastolic blood pressure greater than 110mmHg sustained for more than 15 minutes.

Disqualifiers

History of moderate persistent asthma, coronary artery disease, heart failure, AV heart block, pulmonary edema

Contraindication to either Nifedipine or Labetalol

HR <60 or >110

Native language other than English or Spanish

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral Nifedipine

    Drug

    Administration of oral nifedipine to control postpartum hypertension.

  • Oral Labetalol

    Drug

    Administration of oral labetalol to control postpartum hypertension.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Oral NifedipineActive comparator 1 intervention
Group B: Oral LabetalolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite maternal morbidity

Requiring antihypertensive medication in the postpartum period, readmission for high blood pressure

Time frame
0-6 weeks following delivery

Secondary outcomes

1

Length of hospital stay of mothers

The length of hospital stay for mothers will be measured in hours from the time of admission to labor and delivery unit to the time of discharge from the post-partum unit.

Time frame
Number of hours between time of admission to time of discharge, up to 4 weeks from time of admission.
2

Total number of participants who have need for second antihypertensive agent

The need to use a second (alternative) antihypertensive medication.

Time frame
0-6 weeks following delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loma Linda University

Lead sponsor

Source ClinicalTrials.gov
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