Tocolysis for Preterm Labor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rick Martin, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00811057
First received: December 16, 2008
Last updated: February 25, 2013
Last verified: February 2013
Results First Received: February 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Preterm Labor
Interventions: Drug: 1 Magnesium Sulfate
Drug: Nifedipine
Drug: Indomethacin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants were hospitalized in labor and delivery at University of Mississippi Medical Center in active preterm labor.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
1 Magnesium Sulfate 1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
2 Nifedipine

Participants randomized to this group will receive the medication nifedipine orally.

Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.

3 Indomethacin

Participants randomized to this arm will receive the medication indomethacin per rectum and orally.

Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.


Participant Flow:   Overall Study
    1 Magnesium Sulfate     2 Nifedipine     3 Indomethacin  
STARTED     90     114     97  
COMPLETED     85     104     87  
NOT COMPLETED     5     10     10  
Protocol Violation                 5                 10                 10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 Magnesium Sulfate 1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
2 Nifedipine

Participants randomized to this group will receive the medication nifedipine orally.

Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.

3 Indomethacin

Participants randomized to this arm will receive the medication indomethacin per rectum and orally.

Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.

Total Total of all reporting groups

Baseline Measures
    1 Magnesium Sulfate     2 Nifedipine     3 Indomethacin     Total  
Number of Participants  
[units: participants]
  90     114     97     301  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     90     114     97     301  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  23.9  ± 5.4     22.2  ± 4.3     22.9  ± 4.8     22.5  ± 4.4  
Gender  
[units: participants]
       
Female     90     114     97     301  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     90     114     97     301  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor.   [ Time Frame: 3-5 days after delivery ]

2.  Secondary:   The Secondary Outcome Measure of This Research is the Days Gained After Treatment to Delivery   [ Time Frame: after delivery of the infant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
N/A


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Rick Martin
Organization: University of Mississippi Medical Center
phone: 601-815-7035
e-mail: rmartin@umc.edu


No publications provided


Responsible Party: Rick Martin, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00811057     History of Changes
Other Study ID Numbers: 2003-0249
Study First Received: December 16, 2008
Results First Received: February 25, 2013
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board