Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
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Purpose
Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor. This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective.
Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.
| Condition | Intervention |
|---|---|
|
Obstetric Labor, Premature |
Drug: Indomethacin Drug: Nifedipine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial |
- Recurrent preterm labor within two weeks of randomization [ Time Frame: Two weeks after enrolled and randomized ] [ Designated as safety issue: No ]
- Birth weight, gestational age, delay of delivery, neonatal morbidities, maternal side effects, time to uterine quiescence [ Time Frame: Discharge of mother and neonate ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Indomethacin
50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.
|
Drug: Indomethacin
One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs.
|
|
Active Comparator: Nifedipine
30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.
|
Drug: Nifedipine
Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Singleton and twin gestations
- Intact amniotic membranes
- No contra-indications to tocolysis
- 24-34 weeks gestation by last menstrual period and/or ultrasound
- Documented cervical change, and regular painful uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement
Exclusion Criteria:
- Ruptured amniotic membranes
- Signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 F/38.0 C, fetal tachycardia, uterine tenderness)
- Non-reassuring fetal heart rate tracings
- Contra-indications to indomethacin or nifedipine
- Contra-indications to tocolysis
Contacts and Locations| Contact: Deirdre J Lyell, MD | (650) 736-1191 | dlyell@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Deirdre J Lyell, MD 650-736-1191 dlyell@stanford.edu | |
| Contact: Yair Blumenfeld, MD (650) 269-4665 yairb@stanford.edu | |
| Principal Investigator: Deirdre Judith Lyell | |
| Principal Investigator: | Deirdre Judith Lyell | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00486824 History of Changes |
| Other Study ID Numbers: | 97873 |
| Study First Received: | June 13, 2007 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Indomethacin 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 Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents |
ClinicalTrials.gov processed this record on May 19, 2013