Trial Outcomes & Findings for Indomethacin Versus Nifedipine for Preterm Labor Tocolysis (NCT NCT00486824)
NCT ID: NCT00486824
Last Updated: 2018-10-01
Results Overview
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.
COMPLETED
PHASE1/PHASE2
29 participants
Two weeks after enrolled and randomized, up to 37 weeks of pregnancy
2018-10-01
Participant Flow
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.
Participant milestones
| Measure |
Indomethacin
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.
|
Nifedipine
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 Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Indomethacin Versus Nifedipine for Preterm Labor Tocolysis
Baseline characteristics by cohort
| Measure |
Indomethacin
n=5 Participants
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.
|
Nifedipine
n=5 Participants
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
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
26.0 years
n=99 Participants
|
30 years
n=107 Participants
|
26.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Two weeks after enrolled and randomized, up to 37 weeks of pregnancyPopulation: Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
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.
Outcome measures
| Measure |
Indomethacin
n=5 Participants
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.
|
Nifedipine
n=5 Participants
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.
|
|---|---|---|
|
Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Until discharge of mother and neonate from delivery hospital, up to 30 days after deliveryPopulation: Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Birthweight is presented in grams
Outcome measures
| Measure |
Indomethacin
n=5 Participants
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.
|
Nifedipine
n=5 Participants
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.
|
|---|---|---|
|
Neonatal Birthweight
|
2830 grams
Interval 2750.0 to 2880.0
|
2240 grams
Interval 2000.0 to 2740.0
|
SECONDARY outcome
Timeframe: Up to 42 weeks of pregnancyPopulation: Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Outcome measures
| Measure |
Indomethacin
n=5 Participants
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.
|
Nifedipine
n=5 Participants
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.
|
|---|---|---|
|
Gestational Age at Delivery
|
37.0 weeks
Interval 35.0 to 37.4
|
34.0 weeks
Interval 33.4 to 38.0
|
SECONDARY outcome
Timeframe: Up to 42 weeks of pregnancyPopulation: Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Outcome measures
| Measure |
Indomethacin
n=5 Participants
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.
|
Nifedipine
n=5 Participants
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.
|
|---|---|---|
|
Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery
|
34.0 days
Interval 22.0 to 77.0
|
36.0 days
Interval 28.0 to 52.0
|
SECONDARY outcome
Timeframe: Up to 42 weeks of pregnancyPopulation: Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis.
Outcome measures
| Measure |
Indomethacin
n=5 Participants
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.
|
Nifedipine
n=5 Participants
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.
|
|---|---|---|
|
Count of Participants With Neonatal Morbidity
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 42 weeks of pregnancyPopulation: Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash.
Outcome measures
| Measure |
Indomethacin
n=5 Participants
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.
|
Nifedipine
n=5 Participants
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.
|
|---|---|---|
|
Count of Participants With Side-effect Due to the Medication
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 42 weeks of pregnancyPopulation: Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.
Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days.
Outcome measures
| Measure |
Indomethacin
n=5 Participants
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.
|
Nifedipine
n=4 Participants
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.
|
|---|---|---|
|
Time to Uterine Quiescence
|
2.0 days
Interval 2.0 to 4.0
|
2.0 days
Interval 1.75 to 2.25
|
Adverse Events
Indomethacin
Nifedipine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Indomethacin
n=5 participants at risk
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.
|
Nifedipine
n=5 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
20.0%
1/5 • Number of events 1 • Up to maternal and neonatal discharge from the delivery hospital, up to 30 days after the delivery.
|
40.0%
2/5 • Number of events 2 • Up to maternal and neonatal discharge from the delivery hospital, up to 30 days after the delivery.
|
|
Blood and lymphatic system disorders
Hypotension
|
0.00%
0/5 • Up to maternal and neonatal discharge from the delivery hospital, up to 30 days after the delivery.
|
20.0%
1/5 • Number of events 1 • Up to maternal and neonatal discharge from the delivery hospital, up to 30 days after the delivery.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
20.0%
1/5 • Number of events 1 • Up to maternal and neonatal discharge from the delivery hospital, up to 30 days after the delivery.
|
0.00%
0/5 • Up to maternal and neonatal discharge from the delivery hospital, up to 30 days after the delivery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place