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Trial record 49 of 143 for:    NIFEDIPINE

Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

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ClinicalTrials.gov Identifier: NCT00185900
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 2, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obstetric Labor, Premature
Interventions Drug: Magnesium Sulfate
Drug: Nifedipine
Enrollment 192
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Magnesium Sulfate Nifedipine
Hide Arm/Group Description

Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Period Title: Overall Study
Started 92 100
Completed 92 100
Not Completed 0 0
Arm/Group Title Magnesium Sulfate Nifedipine Total
Hide Arm/Group Description

Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Total of all reporting groups
Overall Number of Baseline Participants 92 100 192
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 100 participants 192 participants
26.6  (6.8) 26.3  (6.3) 26.5  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 100 participants 192 participants
Female
92
 100.0%
100
 100.0%
192
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 92 participants 100 participants 192 participants
92 100 192
1.Primary Outcome
Title Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence
Hide Description Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.
Time Frame 48 hours after administration of study medication.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Magnesium Sulfate Nifedipine
Hide Arm/Group Description:

Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Overall Number of Participants Analyzed 92 100
Measure Type: Count of Participants
Unit of Measure: Participants
80
  87.0%
72
  72.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Magnesium Sulfate, Nifedipine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Time to Uterine Quiescence
Hide Description Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.
Time Frame Until delivery, up to 42 weeks of gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Magnesium Sulfate Nifedipine
Hide Arm/Group Description:

Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Overall Number of Participants Analyzed 92 100
Mean (Standard Deviation)
Unit of Measure: hours
8.4  (6.5) 6.1  (6.3)
3.Secondary Outcome
Title Gestational Age at Delivery
Hide Description Presented as weeks
Time Frame Until delivery, up to 42 weeks of gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Magnesium Sulfate Nifedipine
Hide Arm/Group Description:

Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Overall Number of Participants Analyzed 92 100
Mean (Standard Deviation)
Unit of Measure: weeks
35.8  (3.4) 36.0  (3.1)
4.Secondary Outcome
Title Neonatal Birth Weight
Hide Description Presented as grams
Time Frame Until delivery, up to 42 weeks of gestation
Hide Outcome Measure Data
Hide Analysis Population Description
Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed
Arm/Group Title Magnesium Sulfate Nifedipine
Hide Arm/Group Description:

Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Overall Number of Participants Analyzed 106 110
Mean (Standard Deviation)
Unit of Measure: grams
2550  (802) 2650  (698)
5.Secondary Outcome
Title Serious Maternal Adverse Effect
Hide Description A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.
Time Frame From study enrollment until discharge from delivery hospital, up to 30 days after delivery.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Magnesium Sulfate Nifedipine
Hide Arm/Group Description:

Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Overall Number of Participants Analyzed 92 100
Measure Type: Count of Participants
Unit of Measure: Participants
20
  21.7%
10
  10.0%
6.Secondary Outcome
Title Composite Neonatal Morbidity
Hide Description Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.
Time Frame From delivery until discharge from the hospital, up to 30 days of age
Hide Outcome Measure Data
Hide Analysis Population Description
Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed.
Arm/Group Title Magnesium Sulfate Nifedipine
Hide Arm/Group Description:

Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Overall Number of Participants Analyzed 106 110
Measure Type: Count of Participants
Unit of Measure: Participants
27
  25.5%
22
  20.0%
Time Frame From study enrollment until discharge from the delivery hospital, up to 30 days after delivery.
Adverse Event Reporting Description Adverse events were assessed by patient interview from a list of adverse effects and chart review.
 
Arm/Group Title Magnesium Sulfate Nifedipine
Hide Arm/Group Description

Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

All-Cause Mortality
Magnesium Sulfate Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   0/100 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Magnesium Sulfate Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   25/92 (27.17%)   12/100 (12.00%) 
Cardiac disorders     
Chest pain   7/92 (7.61%)  4/100 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Shortness of breath   13/92 (14.13%)  5/100 (5.00%) 
Pulmonary edema   3/92 (3.26%)  0/100 (0.00%) 
Vascular disorders     
Hypotension   2/92 (2.17%)  3/100 (3.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Magnesium Sulfate Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   29/92 (31.52%)   22/100 (22.00%) 
Cardiac disorders     
Palpitations   1/92 (1.09%)  0/100 (0.00%) 
Eye disorders     
Blurry Vision   12/92 (13.04%)  0/100 (0.00%) 
Double vision   3/92 (3.26%)  0/100 (0.00%) 
Gastrointestinal disorders     
Nausea   29/92 (31.52%)  6/100 (6.00%) 
Vomiting   24/92 (26.09%)  5/100 (5.00%) 
Heartburn   6/92 (6.52%)  6/100 (6.00%) 
Nervous system disorders     
Lethargy   27/92 (29.35%)  3/100 (3.00%) 
Dizziness   16/92 (17.39%)  3/100 (3.00%) 
Headache   11/92 (11.96%)  22/100 (22.00%) 
Skin and subcutaneous tissue disorders     
Flushing   20/92 (21.74%)  1/100 (1.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anna Girsen
Organization: Stanford University
Phone: (650) 725-5720
EMail: agirsen@stanford.edu
Layout table for additonal information
Responsible Party: Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier: NCT00185900     History of Changes
Other Study ID Numbers: 76145
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: February 13, 2018
Results First Posted: October 2, 2018
Last Update Posted: November 19, 2018