Trial Outcomes & Findings for Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor (NCT NCT03129945)
NCT ID: NCT03129945
Last Updated: 2021-11-05
Results Overview
1\. To compare the prolongation of pregnancy by 48 hours after women are diagnosed with threatened preterm labor prior to 32 weeks gestational age and treated with either nifedipine or indomethacin. The primary outcome measured will be delay of (preterm delivery) by 48 hours.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Participants will be followed for the duration of the hospital stay, an expected average of 1 week
Results posted on
2021-11-05
Participant Flow
Study participants were recruited from January 17, 2017, to February 24, 2018.
Participant milestones
| Measure |
Nifedipine
Participants will be given this medication orally
Nifedipine: Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours.
|
Indomethacin
Participants will be given this medication orally
Indomethacin: Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
21
|
|
Overall Study
COMPLETED
|
15
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nifedipine
n=15 Participants
Participants will be given this medication orally
Nifedipine: Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours.
|
Indomethacin
n=21 Participants
Participants will be given this medication orally
Indomethacin: Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
21 Participants
n=21 Participants
|
36 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
21 Participants
n=21 Participants
|
36 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
21 participants
n=21 Participants
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of the hospital stay, an expected average of 1 week1\. To compare the prolongation of pregnancy by 48 hours after women are diagnosed with threatened preterm labor prior to 32 weeks gestational age and treated with either nifedipine or indomethacin. The primary outcome measured will be delay of (preterm delivery) by 48 hours.
Outcome measures
| Measure |
Nifedipine
n=15 Participants
Participants will be given this medication orally
Nifedipine: Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours.
|
Indomethacin
n=21 Participants
Participants will be given this medication orally
Indomethacin: Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment.
|
|---|---|---|
|
Number of Participants With Delay of Preterm Delivery by 48 Hours.
|
15 Participants
|
21 Participants
|
Adverse Events
Nifedipine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Indomethacin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nifedipine
n=15 participants at risk
Participants will be given this medication orally
Nifedipine: Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours.
|
Indomethacin
n=21 participants at risk
Participants will be given this medication orally
Indomethacin: Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected through study completion, for an average of 1 week.
Adverse event definition did not differ from the clinicaltrials.gov definitions.
|
0.00%
0/21 • Adverse event data were collected through study completion, for an average of 1 week.
Adverse event definition did not differ from the clinicaltrials.gov definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place