Nifedipine for Acute Tocolysis of Preterm Labor

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02132533
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Actual Duration (Months): 53.8
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.

Condition or Disease	Intervention/Treatment	Phase
Preterm Labor	Drug: Nifedipine; Drug: Placebo; Other: Usual care	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Nifedipine for Acute Tocolysis of Preterm Labor
• Actual Study Start Date: May 5, 2014
• Actual Primary Completion Date: Oct 29, 2018
• Actual Study Completion Date: Oct 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nifedipine Women with preterm labor will receive nifedipine.	Drug: 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.; Other: Usual care; Usual evaluation, monitoring and care for women with preterm labor.
Experimental: Placebo Women with preterm labor will receive placebo.	Drug: 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.; Other: Usual care; Usual evaluation, monitoring and care for women with preterm labor.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Preterm Birth [Less than 37 weeks of gestation]

Secondary Outcome Measures

1. Number of Participants With Preterm Birth [Within 48 hours of randomization]

2. Number of Participants With Preterm Birth [At least 2 doses of betamethasone administered prior to delivery]

3. Number of Participants With Preterm Birth [Within 7 days of randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Between 16 and 44 years of age inclusive

• Singleton pregnancy

• Intact membranes

• Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive

• Reported or documented uterine activity

• Cervical dilation between 2 cm and 4 cm inclusive

Exclusion Criteria:

• Multifetal gestation

• Less than 28 weeks' gestation

• 34 or more weeks' gestation

• Ruptured membranes

• More than 4 cm dilated

• Previously received a course of corticosteroids for fetal lung maturation

• Oligohydramnios

• Fetal growth restriction

• Chorioamnionitis or temperature of at least 38.0 degrees Celsius

• Fetal death

• Preeclampsia

• Suspected placental abruption or placenta previa

• Lethal fetal malformation or amniotic fluid index at least 35

• Systolic BP < 90 mmHg or diastolic BP < 50 mmHg

• Baseline tachycardia (pulse >120 after 2 consecutive measurements 30 minutes apart)

• Chronic hypertension treated with antihypertensives in pregnancy

• Seizure disorder or HIV

• Maternal allergy to nifedipine

• Known maternal cardiac disease

• Women who have received progesterone therapy in the second or third trimester for prevention of preterm birth

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkland Memorial Hospital	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Study Director: Brian M Casey, MD, Department of Alabama Medical Center, Birmingham, AL
• Study Director: Donald D McIntire, PhD, University of Texas Southwestern Medical Center
• Study Director: Kenneth J Leveno, MD, University of Texas Southwestern Medical Center
• Study Director: Chet E Wells, MD, University of Texas Southwestern Medical Center
• Principal Investigator: Josiah S Hawkins, MD, Kaiser Medical Center, Oakland, CA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 22, 2018

More Information

Publications

None provided.

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02132533
• Other Study ID Numbers: 122013-063
• First Posted: May 7, 2014
• Last Update Posted: Dec 21, 2020
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Premature Birth; Obstetric Labor, Premature; Nifedipine

Study Results

Participant Flow

Arm/Group Title	Nifedipine	Placebo
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	46	42
COMPLETED	46	42
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Nifedipine	Placebo	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	46	42	88
Age (Count of Participants)
<=18 years	1 2.2%	5 11.9%	6 6.8%
Between 18 and 65 years	45 97.8%	37 88.1%	82 93.2%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.5 (5.8)	26.7 (6.7)	26.1 (6.2)
Sex: Female, Male (Count of Participants)
Female	46 100%	42 100%	88 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Black	10 21.7%	6 14.3%	16 18.2%
White	1 2.2%	1 2.4%	2 2.3%
Hispanic	35 76.1%	35 83.3%	70 79.5%
Region of Enrollment (participants) [Number]
United States	46 100%	42 100%	88 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Preterm Birth
Time Frame	Less than 37 weeks of gestation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nifedipine	Placebo
Arm/Group Description	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.	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.
Measure Participants	46	42
Count of Participants [Participants]	24 52.2%	20 47.6%

2. Secondary Outcome

Title	Number of Participants With Preterm Birth
Time Frame	Within 48 hours of randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nifedipine	Placebo
Arm/Group Description	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.	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.
Measure Participants	46	42
Count of Participants [Participants]	8 17.4%	10 23.8%

3. Secondary Outcome

Title	Number of Participants With Preterm Birth
Time Frame	At least 2 doses of betamethasone administered prior to delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nifedipine	Placebo
Arm/Group Description	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.	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.
Measure Participants	46	42
Count of Participants [Participants]	36 78.3%	31 73.8%

4. Secondary Outcome

Title	Number of Participants With Preterm Birth
Time Frame	Within 7 days of randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nifedipine	Placebo
Arm/Group Description	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.	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.
Measure Participants	46	42
Count of Participants [Participants]	13 28.3%	14 33.3%

Adverse Events

Time Frame	4 years
Arm/Group Title	Nifedipine		Placebo
Arm/Group Description	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.		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.
All Cause Mortality
	Nifedipine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/42 (0%)
Serious Adverse Events
	Nifedipine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Nifedipine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/42 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.