Oral Nifedipine Versus Oral Labetalol

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02168309
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

This study's aim is to determine whether oral extended release nifedipine is superior to oral labetolol for the management of postpartum severe hypertension, specifically time to achieve goal blood pressure, and shortening hospital stay. Our hypothesis is that oral extended release nifedipine is superior to oral labetolol for achieving goal blood pressure in the postpartum period.

Condition or Disease	Intervention/Treatment	Phase
Severe Postpartum Hypertension	Drug: Labetalol; Drug: Nifedipine	N/A

Detailed Description

Hypertension complicating pregnancy is common and, when uncontrolled, can have devastating consequences. While the true incidence of postpartum hypertension is unknown, blood pressure (BP) is known to initially decrease 48 hours following delivery then peak on postpartum days 3-6, likely 45 from the mobilization of interstitial fluids following parturition.

The American College of Obstetricians and Gynecologists (ACOG) recommends medical treatment of persistent postpartum hypertension, defined as systolic BP (SBP) ≥150 mmHg or diastolic BP (DBP) ≥100 mmHg, on two or more occasions 4-6 hours apart. Prior studies compared intravenous medications to intramuscular and immediate-release oral 50 medications in the treatment of postpartum hypertension. However, oral labetalol and oral extended release nifedipine are the most commonly used medications for post- partum hypertension, and their efficacy has not been directly compared.

Our aim was to determine whether oral labetalol is associated with a shorter time to BP control compared to oral extended release nifedipine for management of persistent 55 postpartum hypertension. Our primary outcome was time to sustained BP control defined as the absence of severe hypertension (SBP ≥160 mmHg or DBP ≥105 mmHg) for at least 12 hours. Secondary outcomes included postpartum length of stay, need for increased dosing, need for additional oral antihypertensive agents, and patient-reported side effects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Oral Nifedipine to Oral Labetolol for the Management of Severe Postpartum Hypertension
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Labetalol Labetalol 200mg PO BID starting dose	Drug: Labetalol; Titrate up for blood pressure control; Other Names: Oral labetalol starting at dose 200mg PO BID
Other: Nifedipine Nifedpine XL starting at dose 30mg PO daily	Drug: Nifedipine; Titrate up to achieve blood pressure control; Other Names: Oral nifedipine 30mg XL PO starting

Outcome Measures

Primary Outcome Measures

1. Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication [24 hours]

   Primary outcome

Secondary Outcome Measures

1. Total Length of Hospital Stay in Days [0-10 days]

   Secondary outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years with the abililty to give informed consent

• Intrauterine pregnancy ≥ 32 weeks

• Postpartum

• Persistent postpartum blood pressures ≥ 160/105 on two or more occasions

• Primary obstetrician amenable to starting either study medication in the postpartum period

Exclusion Criteria:

• Use of other oral antihypertensives concomitantly

• Known AV heart block

• HR <60 or >120

• Absolute contraindication to nifedipine or labetolol such as allergy

• Significant renal disease (Cr >1.5 mg/dL)

• Heart failure

• Moderate persistent or severe asthma

• Preexisting diagnosis of chronic hypertension with medical treatment before delivery

• Chronic hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center

Investigators

• Principal Investigator: Sarah Kilpatrick, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Kilpatrick, Chair, Department of Obstetrics & Gynecology, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT02168309
• Other Study ID Numbers: Pro34034
• First Posted: Jun 20, 2014
• Last Update Posted: Dec 13, 2017
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: Hypertension; Labetalol; Nifedipine

Study Results

Participant Flow

Arm/Group Title	Labetalol	Nifedipine
Arm/Group Description	Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control	Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Labetalol	Nifedipine	Total
Arm/Group Description	Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control	Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	50 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34 (7.4)	33.3 (6.4)	33.7 (6.9)
Sex: Female, Male (Count of Participants)
Female	25 100%	25 100%	50 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 32%	9 36%	17 34%
Not Hispanic or Latino	17 68%	16 64%	33 66%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.3 (4.1)	33.0 (7.8)	31.7 (6.0)

Outcome Measures

1. Primary Outcome

Title	Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication
Description	Primary outcome
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Labetalol	Nifedipine
Arm/Group Description	Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control	Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control
Measure Participants	25	25
Mean (Standard Deviation) [hours]	37.6 (32.5)	38.2 (27.6)

2. Secondary Outcome

Title	Total Length of Hospital Stay in Days
Description	Secondary outcome
Time Frame	0-10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Labetalol	Nifedipine
Arm/Group Description	Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control	Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control
Measure Participants	25	25
Mean (Standard Deviation) [days]	4.0 (1.5)	4.3 (2.3)

Adverse Events

Arm/Group Title	Labetalol		Nifedipine
Arm/Group Description	Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control		Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control
All Cause Mortality
	Labetalol		Nifedipine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Labetalol		Nifedipine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Labetalol		Nifedipine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.