Trial Outcomes & Findings for Nifedipine for Acute Tocolysis of Preterm Labor (NCT NCT02132533)

NCT ID: NCT02132533

Last Updated: 2020-12-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 88 participants
• Primary outcome timeframe: Less than 37 weeks of gestation
• Results posted on: 2020-12-21

Participant Flow

Participant milestones

Measure	Nifedipine Women with preterm labor will receive nifedipine. Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.	Placebo Women with preterm labor will receive placebo. Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.
Overall Study STARTED	46	42
Overall Study COMPLETED	46	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nifedipine for Acute Tocolysis of Preterm Labor

Baseline characteristics by cohort

Measure	Nifedipine n=46 Participants Women with preterm labor will receive nifedipine. Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.	Placebo n=42 Participants Women with preterm labor will receive placebo. Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	37 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25.5 years STANDARD_DEVIATION 5.8 • n=5 Participants	26.7 years STANDARD_DEVIATION 6.7 • n=7 Participants	26.1 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	42 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	42 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: Less than 37 weeks of gestation

Outcome measures

Measure	Nifedipine n=46 Participants Women with preterm labor will receive nifedipine. Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.	Placebo n=42 Participants Women with preterm labor will receive placebo. Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.
Number of Participants With Preterm Birth	24 Participants	20 Participants

SECONDARY outcome

Timeframe: Within 48 hours of randomization

Outcome measures

Measure	Nifedipine n=46 Participants Women with preterm labor will receive nifedipine. Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.	Placebo n=42 Participants Women with preterm labor will receive placebo. Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.
Number of Participants With Preterm Birth	8 Participants	10 Participants

SECONDARY outcome

Timeframe: At least 2 doses of betamethasone administered prior to delivery

Outcome measures

Measure	Nifedipine n=46 Participants Women with preterm labor will receive nifedipine. Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.	Placebo n=42 Participants Women with preterm labor will receive placebo. Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.
Number of Participants With Preterm Birth	36 Participants	31 Participants

SECONDARY outcome

Timeframe: Within 7 days of randomization

Outcome measures

Measure	Nifedipine n=46 Participants Women with preterm labor will receive nifedipine. Nifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.	Placebo n=42 Participants Women with preterm labor will receive placebo. Placebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. Usual care: Usual evaluation, monitoring and care for women with preterm labor.
Number of Participants With Preterm Birth	13 Participants	14 Participants

Adverse Events

Nifedipine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Chet Edward Wells, MD

UT Southwestern Medical Center

Phone: 214-648-2316

Email: dawn.wilson@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place