Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486824
Status:
COMPLETED
Last Update Posted:
2018-10-01
First Post:
2007-06-13
Brief Title:
Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Patients presenting between 24-34 weeks gestation 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 Antibiotics and steroids for fetal lung maturity will be administered as per standard of care for preterm labor Maternal side effects and delivery outcomes will be assessed from questionnaires administered by the study team following treatment andor from review of the patients medical records
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None