Tocolysis for Preterm Labor
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Purpose
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 | Intervention |
|---|---|
|
Preterm Labor |
Drug: 1 Magnesium Sulfate Drug: Nifedipine Drug: Indomethacin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tocolysis for Preterm Labor |
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Days gained after treatment to delivery
| Enrollment: | 301 |
| Study Start Date: | June 2004 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
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Active Comparator: 2 Nifedipine
Participants randomized to this group will receive the medication nifedipine orally.
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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.
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Active Comparator: 3 Indomethacin
Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
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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.
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Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders 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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Rick Martin, Associate Professor Maternal-Fetal Medicine; Dept of Ob-Gyn, 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 |
Keywords provided by University of Mississippi Medical Center:
|
Preterm Labor in Pregnancy |
Additional relevant MeSH terms:
|
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Indomethacin Magnesium Sulfate Nifedipine Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators |
ClinicalTrials.gov processed this record on May 19, 2013