Tocolysis for Preterm Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00811057
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Information provided by (Responsible Party):
Rick Martin, University of Mississippi Medical Center

Brief Summary:
Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is used by about 95% of all practitioners, but recent data suggest magnesium given this way may be harmful for the baby's future development. Other drugs such as antiprostaglandin agents are very effective in stopping uterine activity, but particularly when used for >48 hours have been associated with both maternal and fetal sides effects. Lastly, calcium channel antagonists are effective in stopping contractions and have very little in the way of maternal and fetal side effects, but less data is available in the United States on their use. Because there is no FDA approved drug to stop preterm labor, we purpose to randomize all women with preterm labor (20-34 weeks) to receive one of the above three methods of stopping preterm labor. The primary outcomes will be to see which agent stops the uterine contractions most effectively, for the longest period of time with fewest relapses and results in significant prolongation of pregnancy. If one of these agents is clearly superior to the other two it would help women avoid early delivery or have significant extension of their pregnancy to avoid some of the complications of preterm birth in the baby.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tocolysis for Preterm Labor
Study Start Date : June 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: 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.

Active Comparator: 3 Indomethacin
Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Drug: 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pregnancies with intact membranes in confirmed preterm labor;
  • 20 - 32 weeks' gestation;
  • Cervical dilatation 0 - 3cm versus 4 - 6cm;
  • No conditions contraindicating continued pregnancy (severe IUGR, chorioamnionitis, non-reassuring fetal tracing - physician judgement); AND
  • Able and willing to consent to the study protocol.

Exclusion Criteria:

  • Failure to meet admission criteria;
  • Known serious fetal malformations;
  • Severe maternal/obstetric disease affecting the mother or fetus (severe cardiac disease, placental abruption/previa, severe diabetes, severe preeclampsia, etc. - physician judgment);
  • Allergic to magnesium, antiprostaglandin or calcium channel antagonist;
  • Refusal or inability to consent to the study

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
University of Mississippi Medical Center
Principal Investigator: Rick W Martin, MD University of Mississippi Medical Center

Responsible Party: Rick Martin, Associate Professor Maternal-Fetal Medicine; Dept of Ob-Gyn, University of Mississippi Medical Center Identifier: NCT00811057     History of Changes
Other Study ID Numbers: 2003-0249
First Posted: December 18, 2008    Key Record Dates
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013
Last Verified: February 2013

Keywords provided by Rick Martin, University of Mississippi Medical Center:
Preterm Labor in Pregnancy

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Vasodilator Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors