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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02132533
Other study ID # 122013-063
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 5, 2014
Est. completion date October 29, 2018

Study information

Verified date December 2020
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date October 29, 2018
Est. primary completion date October 29, 2018
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 44 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Parkland Memorial Hospital Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Preterm Birth Less than 37 weeks of gestation
Secondary Number of Participants With Preterm Birth Within 48 hours of randomization
Secondary Number of Participants With Preterm Birth At least 2 doses of betamethasone administered prior to delivery
Secondary Number of Participants With Preterm Birth Within 7 days of randomization
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