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
  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

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811057

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
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
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 July 22, 2014