Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
Primary Purpose
Obstetric Labor, Premature
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indomethacin
Nifedipine
Sponsored by
About this trial
This is an interventional treatment trial for Obstetric Labor, Premature
Eligibility Criteria
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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Indomethacin
Nifedipine
Arm Description
50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.
30 mg Nifedipine initially followed by 20 mg every 6 hrs for 48 hrs.
Outcomes
Primary Outcome Measures
Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization
Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy.
Secondary Outcome Measures
Neonatal Birthweight
Birthweight is presented in grams
Gestational Age at Delivery
Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery
Count of Participants With Neonatal Morbidity
Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis.
Count of Participants With Side-effect Due to the Medication
Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash.
Time to Uterine Quiescence
Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00486824
Brief Title
Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
Official Title
Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2007 (Actual)
Primary Completion Date
December 8, 2012 (Actual)
Study Completion Date
December 8, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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, and/or from review of the patient's medical records.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor, Premature
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indomethacin
Arm Type
Active Comparator
Arm Description
50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.
Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
30 mg Nifedipine initially followed by 20 mg every 6 hrs for 48 hrs.
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.
Primary Outcome Measure Information:
Title
Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization
Description
Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy.
Time Frame
Two weeks after enrolled and randomized, up to 37 weeks of pregnancy
Secondary Outcome Measure Information:
Title
Neonatal Birthweight
Description
Birthweight is presented in grams
Time Frame
Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery
Title
Gestational Age at Delivery
Time Frame
Up to 42 weeks of pregnancy
Title
Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery
Time Frame
Up to 42 weeks of pregnancy
Title
Count of Participants With Neonatal Morbidity
Description
Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis.
Time Frame
Up to 42 weeks of pregnancy
Title
Count of Participants With Side-effect Due to the Medication
Description
Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash.
Time Frame
Up to 42 weeks of pregnancy
Title
Time to Uterine Quiescence
Description
Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days.
Time Frame
Up to 42 weeks of pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deirdre Judith Lyell
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35947046
Citation
Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Results Reference
derived
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Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
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