Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age19+
SponsorNebraska Methodist Health System

About this trial

Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

  • Labetalol Oral Tablet

    Drug

    See Labetalol arm.

  • NIFEdipine ER

    Drug

    See Nifedipine arm.

Treatment groups

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

Trial outcomes

Primary outcomes

1

Readmission

Patients will be monitored following delivery for readmission to the hospital. To improve patient capture, all patients will be called at 6 months to identify complications or if hospital admission occured in the 6 months following delivery

Time frame
6 months

Secondary outcomes

1

Medication failure

Need for additional antihypertensive medication

Time frame
Any time during the 6 months following delivery
2

Medication change or discontinuation

Need to change medication or discontinue medication due to side effects or complications of medication.

Time frame
Any time during the 6 months following delivery

Other outcomes

Sponsors and contacts

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