Trial Outcomes & Findings for Tocolysis for Preterm Labor (NCT NCT00811057)
NCT ID: NCT00811057
Last Updated: 2013-04-04
Results Overview
Gestational age at delivery in weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
3-5 days after delivery
Results posted on
2013-04-04
Participant Flow
All participants were hospitalized in labor and delivery at University of Mississippi Medical Center in active preterm labor.
Participant milestones
| Measure |
1 Magnesium Sulfate
1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
|
2 Nifedipine
Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.
|
3 Indomethacin
Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.
|
|---|---|---|---|
|
Overall Study
STARTED
|
90
|
114
|
97
|
|
Overall Study
COMPLETED
|
85
|
104
|
87
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
10
|
Reasons for withdrawal
| Measure |
1 Magnesium Sulfate
1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
|
2 Nifedipine
Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.
|
3 Indomethacin
Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
10
|
10
|
Baseline Characteristics
Tocolysis for Preterm Labor
Baseline characteristics by cohort
| Measure |
1 Magnesium Sulfate
n=90 Participants
1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
|
2 Nifedipine
n=114 Participants
Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.
|
3 Indomethacin
n=97 Participants
Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
301 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
23.9 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
22.2 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
22.9 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
22.5 years
STANDARD_DEVIATION 4.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
301 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=5 Participants
|
114 participants
n=7 Participants
|
97 participants
n=5 Participants
|
301 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3-5 days after deliveryGestational age at delivery in weeks.
Outcome measures
| Measure |
1 Magnesium Sulfate
n=90 Participants
1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
|
2 Nifedipine
n=114 Participants
Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.
|
3 Indomethacin
n=97 Participants
Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.
|
|---|---|---|---|
|
The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor.
|
31.2 weeks
Standard Deviation 3.9
|
31.8 weeks
Standard Deviation 4.5
|
31.8 weeks
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: after delivery of the infantDays gained after treatment to delivery
Outcome measures
| Measure |
1 Magnesium Sulfate
n=90 Participants
1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
|
2 Nifedipine
n=114 Participants
Participants randomized to this group will receive the medication nifedipine orally.
Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved.
|
3 Indomethacin
n=97 Participants
Participants randomized to this arm will receive the medication indomethacin per rectum and orally.
Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved.
|
|---|---|---|---|
|
The Secondary Outcome Measure of This Research is the Days Gained After Treatment to Delivery
|
22.5 days
Standard Deviation 43.8
|
21.7 days
Standard Deviation 21.7
|
22.7 days
Standard Deviation 21.1
|
Adverse Events
1 Magnesium Sulfate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Nifedipine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 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
Adverse event data not reported
Additional Information
Dr. Rick Martin
University of Mississippi Medical Center
Phone: 601-815-7035
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place