Tocolysis for Preterm Labor
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|ClinicalTrials.gov Identifier: NCT00811057|
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Preterm Labor||Drug: 1 Magnesium Sulfate Drug: Nifedipine Drug: Indomethacin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||301 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tocolysis for Preterm Labor|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2010|
|Active Comparator: 1 Magnesium Sulfate||
Drug: 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.
Active Comparator: 2 Nifedipine
Participants randomized to this group will receive the medication nifedipine orally.
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.
Active Comparator: 3 Indomethacin
Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
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.
- 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 ]Gestational age at delivery in weeks.
- The Secondary Outcome Measure of This Research is the Days Gained After Treatment to Delivery [ Time Frame: after delivery of the infant ]Days gained after treatment to delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811057
|United States, Mississippi|
|The Winfred L. Wiser Hospital for Women and Infants at the University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||Rick W Martin, MD||University of Mississippi Medical Center|