Nifedipine for Acute Tocolysis of Preterm Labor (Nifedipine)
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ClinicalTrials.gov Identifier: NCT02132533 |
Recruitment Status :
Completed
First Posted : May 7, 2014
Results First Posted : February 21, 2020
Last Update Posted : December 21, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preterm Labor | Drug: Nifedipine Drug: Placebo Other: Usual care | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | October 29, 2018 |
Actual Study Completion Date : | October 29, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Nifedipine
Women with preterm labor will receive nifedipine.
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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. |
- Number of Participants With Preterm Birth [ Time Frame: Less than 37 weeks of gestation ]
- Number of Participants With Preterm Birth [ Time Frame: Within 48 hours of randomization ]
- Number of Participants With Preterm Birth [ Time Frame: At least 2 doses of betamethasone administered prior to delivery ]
- Number of Participants With Preterm Birth [ Time Frame: Within 7 days of randomization ]

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Ages Eligible for Study: | 16 Years to 44 Years (Child, Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132533
United States, Texas | |
Parkland Memorial Hospital | |
Dallas, Texas, United States, 75390 |
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 |
Documents provided by University of Texas Southwestern Medical Center:
Responsible Party: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT02132533 |
Other Study ID Numbers: |
122013-063 |
First Posted: | May 7, 2014 Key Record Dates |
Results First Posted: | February 21, 2020 |
Last Update Posted: | December 21, 2020 |
Last Verified: | December 2020 |
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Nifedipine Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Tocolytic Agents Reproductive Control Agents |