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Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

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ClinicalTrials.gov Identifier: NCT00486824
Recruitment Status : Completed
First Posted : June 15, 2007
Results First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Deirdre Judith Lyell, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obstetric Labor, Premature
Interventions Drug: Indomethacin
Drug: Nifedipine
Enrollment 29
Recruitment Details A total of 29 patients were initially consented and enrolled. Patients were enrolled through December 2012 but protocol remained open until 2018. Due to patient privacy regulations, the data were accessible for only 10 patients.
Pre-assignment Details  
Arm/Group Title Indomethacin Nifedipine
Hide Arm/Group Description

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Period Title: Overall Study
Started 5 5
Completed 3 3
Not Completed 2 2
Arm/Group Title Indomethacin Nifedipine Total
Hide Arm/Group Description

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
Data were accessible for limited participants due to patient privacy regulations.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
26.0
(20.0 to 37.0)
30
(19.0 to 37.0)
26.5
(19.0 to 37.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
5
 100.0%
5
 100.0%
10
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Arm/Group Title Indomethacin Nifedipine
Hide Arm/Group Description:

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Overall Number of Participants Analyzed 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
1
  20.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin, Nifedipine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Neonatal Birthweight
Hide Description Birthweight is presented in grams
Time Frame Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Arm/Group Title Indomethacin Nifedipine
Hide Arm/Group Description:

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: grams
2830
(2750 to 2880)
2240
(2000 to 2740)
3.Secondary Outcome
Title Gestational Age at Delivery
Hide Description [Not Specified]
Time Frame Up to 42 weeks of pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Arm/Group Title Indomethacin Nifedipine
Hide Arm/Group Description:

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: weeks
37.0
(35.0 to 37.4)
34.0
(33.4 to 38.0)
4.Secondary Outcome
Title Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery
Hide Description [Not Specified]
Time Frame Up to 42 weeks of pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Arm/Group Title Indomethacin Nifedipine
Hide Arm/Group Description:

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: days
34.0
(22.0 to 77.0)
36.0
(28.0 to 52.0)
5.Secondary Outcome
Title Count of Participants With Neonatal Morbidity
Hide Description Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis.
Time Frame Up to 42 weeks of pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Arm/Group Title Indomethacin Nifedipine
Hide Arm/Group Description:

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Overall Number of Participants Analyzed 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
3
  60.0%
6.Secondary Outcome
Title Count of Participants With Side-effect Due to the Medication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Arm/Group Title Indomethacin Nifedipine
Hide Arm/Group Description:

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Overall Number of Participants Analyzed 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
3
  60.0%
7.Secondary Outcome
Title Time to Uterine Quiescence
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Arm/Group Title Indomethacin Nifedipine
Hide Arm/Group Description:

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Overall Number of Participants Analyzed 5 4
Median (Inter-Quartile Range)
Unit of Measure: days
2.0
(2.0 to 4.0)
2.0
(1.75 to 2.25)
Time Frame Up to maternal and neonatal discharge from the delivery hospital, up to 30 days after the delivery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Indomethacin Nifedipine
Hide Arm/Group Description

50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs.

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.

30 mg Nifedipine initially followed by 10 mg every 6 hrs for 48 hrs.

Nifedipine: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

All-Cause Mortality
Indomethacin Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Indomethacin Nifedipine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Indomethacin Nifedipine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      3/5 (60.00%)    
Blood and lymphatic system disorders     
Hypotension *  0/5 (0.00%)  0 1/5 (20.00%)  1
Gastrointestinal disorders     
Gastrointestinal symptoms *  1/5 (20.00%)  1 2/5 (40.00%)  2
Skin and subcutaneous tissue disorders     
Skin rash *  1/5 (20.00%)  1 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
The sample size for the analysis was not reached.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Deirdre Lyell
Organization: Stanford University
Phone: 6507255720
EMail: dlyell@stanford.edu
Layout table for additonal information
Responsible Party: Deirdre Judith Lyell, Stanford University
ClinicalTrials.gov Identifier: NCT00486824     History of Changes
Other Study ID Numbers: 97873
First Submitted: June 13, 2007
First Posted: June 15, 2007
Results First Submitted: August 31, 2018
Results First Posted: October 1, 2018
Last Update Posted: October 1, 2018