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Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438371
Recruitment Status : Terminated (Study halted due to slow recruitment)
First Posted : May 8, 2015
Results First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Jerrie Refuerzo, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Preterm Labor
Interventions Drug: Nifedipine
Drug: Indomethacin
Enrollment 49
Recruitment Details  
Pre-assignment Details The numbers listed in the Participant Flow section correspond to maternal participants.
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours. Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Period Title: Overall Study
Started 24 25
Received Intervention 24 25
Completed 20 22
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             3             2
Withdrawal by Subject             1             1
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin Total
Hide Arm/Group Description Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours. Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours. Total of all reporting groups
Overall Number of Baseline Participants 20 22 42
Hide Baseline Analysis Population Description
Baseline characteristics are reported for all who completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 22 participants 42 participants
28.0  (7.5) 28.5  (7.7) 28.3  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 22 participants 42 participants
Female
20
 100.0%
22
 100.0%
42
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 20 participants 22 participants 42 participants
African/African American/Black American
9
  45.0%
15
  68.2%
24
  57.1%
Asian
1
   5.0%
0
   0.0%
1
   2.4%
Hispanic
7
  35.0%
6
  27.3%
13
  31.0%
White
3
  15.0%
1
   4.5%
4
   9.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants 22 participants 42 participants
20
 100.0%
22
 100.0%
42
 100.0%
1.Primary Outcome
Title Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation
Hide Description [Not Specified]
Time Frame 48 hours after administration of tocolytic agent
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 in the Nifedipine arm.
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 16 22
Measure Type: Count of Participants
Unit of Measure: Participants
15
  93.8%
20
  90.9%
2.Secondary Outcome
Title Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation
Hide Description [Not Specified]
Time Frame 7 days after administration of tocolytic agent
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 in the Nifedipine arm.
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 16 22
Measure Type: Count of Participants
Unit of Measure: Participants
12
  75.0%
18
  81.8%
3.Secondary Outcome
Title Number of Days From First Dose of Tocolytic Agent to Delivery
Hide Description Length of time from tocolytic initiation to the time of delivery
Time Frame from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 in the Nifedipine arm.
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 16 22
Median (Inter-Quartile Range)
Unit of Measure: days
24.8
(6.9 to 49.8)
42.6
(24.1 to 61.8)
4.Secondary Outcome
Title Neonatal Birthweight
Hide Description [Not Specified]
Time Frame at the time of birth
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm and 1 neonate in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 22
Median (Inter-Quartile Range)
Unit of Measure: grams
1870.0
(1451.2 to 2317.5)
2571.0
(1733.8 to 3073.8)
5.Secondary Outcome
Title Neonatal Sex
Hide Description [Not Specified]
Time Frame at the time of birth
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 23
Measure Type: Count of Participants
Unit of Measure: Participants
Female
6
  27.3%
9
  39.1%
Male
16
  72.7%
14
  60.9%
6.Secondary Outcome
Title Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm and 1 neonate in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
16
  72.7%
13
  59.1%
7.Secondary Outcome
Title Neonatal Length of Stay in NICU
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 10 neonates in the Nifedipine arm and 10 neonates in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 16 13
Median (Inter-Quartile Range)
Unit of Measure: days
36.3
(26.0 to 46.2)
25.3
(14.0 to 52.2)
8.Secondary Outcome
Title Neonatal Length of Hospital Stay
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm and 1 neonate in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 22
Median (Inter-Quartile Range)
Unit of Measure: days
31.8
(3.0 to 44.7)
10.9
(2.5 to 27.4)
9.Secondary Outcome
Title Number of Neonatal Deaths
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm and 2 neonates in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.5%
1
   4.8%
10.Secondary Outcome
Title Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm and 2 neonates in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
3
  13.6%
2
   9.5%
11.Secondary Outcome
Title Number of Neonates With Necrotizing Enterocolitis
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm and 2 neonates in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
2
   9.1%
0
   0.0%
12.Secondary Outcome
Title Number of Neonates With Culture-positive Sepsis
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm and 2 neonates in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
3
  13.6%
3
  14.3%
13.Secondary Outcome
Title Number of Neonates With Seizures
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm and 2 neonates in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   4.8%
14.Secondary Outcome
Title Number of Neonates Who Needed Mechanical Ventilation
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 neonates in the Nifedipine arm and 2 neonates in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
4
  18.2%
3
  14.3%
15.Secondary Outcome
Title Neonatal Duration of Ventilator Use
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 22 neonates in the Nifedipine arm and 20 neonates in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 4 3
Median (Inter-Quartile Range)
Unit of Measure: hours
32.5
(25.4 to 414.8)
186.0
(103.0 to 1593.0)
16.Secondary Outcome
Title Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP)
Hide Description [Not Specified]
Time Frame from birth until hospital discharge or day 120 of life (whichever occurs first)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 5 neonates in the Nifedipine arm and 2 neonates in the Nifedipine plus Indomethacin arm. (There are more neonates than maternal participants because 6 mothers in the Nifedipine arm had twins and 1 mother in the Nifedipine plus Indomethacin arm had twins.)
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 21 21
Measure Type: Count of Participants
Unit of Measure: Participants
11
  52.4%
8
  38.1%
17.Secondary Outcome
Title Number of Maternal Participants Who Delivered by Cesarean Delivery
Hide Description [Not Specified]
Time Frame at the the time of birth
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 in the Nifedipine arm.
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 16 22
Measure Type: Count of Participants
Unit of Measure: Participants
5
  31.3%
5
  22.7%
18.Secondary Outcome
Title Number of Maternal Participants Who Had Clinical Chorioamnionitis
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 in the Nifedipine arm and 1 in the Nifedipine plus Indomethacin arm.
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 16 21
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.3%
0
   0.0%
19.Secondary Outcome
Title Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM)
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure were not collected for 4 in the Nifedipine arm and 1 in the Nifedipine plus Indomethacin arm.
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 16 21
Measure Type: Count of Participants
Unit of Measure: Participants
2
  12.5%
2
   9.5%
20.Secondary Outcome
Title Number of Maternal Participants Who Had Preeclampsia
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
2
   9.1%
21.Secondary Outcome
Title Number of Maternal Participants Who Needed Blood Transfusion
Hide Description [Not Specified]
Time Frame from time of birth to time of discharge from hospital (about 2-3 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
1
   4.5%
22.Secondary Outcome
Title Number of Maternal Participants With Headache
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   4.5%
23.Secondary Outcome
Title Number of Maternal Participants With Nausea
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
0
   0.0%
24.Secondary Outcome
Title Number of Maternal Participants With Vomiting
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
25.Secondary Outcome
Title Number of Maternal Participants With Acid Reflux
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
1
   4.5%
26.Secondary Outcome
Title Number of Maternal Participants With Hypotension
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
1
   4.5%
27.Secondary Outcome
Title Number of Maternal Participants With Tachycardia
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
1
   4.5%
28.Secondary Outcome
Title Number of Maternal Participants With Syncope
Hide Description [Not Specified]
Time Frame from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description:
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours.
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
Overall Number of Participants Analyzed 20 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Maternal participants: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) Neonates: from birth until hospital discharge or day 120 of life (whichever occurs first)
Adverse Event Reporting Description Adverse Events are reported for 20 maternal participants and 26 neonates in the Nifedipine arm (6 mothers in the Nifedipine arm had twins) and are reported for 22 maternal participants and 23 neonates in the Nifedipine Plus Indomethacin arm (1 mother in the Nifedipine Plus Indomethacin arm had twins). The 2 deaths were neonatal deaths (there were no maternal deaths).
 
Arm/Group Title Nifedipine Nifedipine Plus Indomethacin
Hide Arm/Group Description Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours. Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours, for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours, for a total of 48 hours.
All-Cause Mortality
Nifedipine Nifedipine Plus Indomethacin
Affected / at Risk (%) Affected / at Risk (%)
Total   1/46 (2.17%)      1/45 (2.22%)    
Hide Serious Adverse Events
Nifedipine Nifedipine Plus Indomethacin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/46 (52.17%)      38/45 (84.44%)    
Eye disorders     
Retinopathy of prematurity (neonatal) †  4/26 (15.38%)  4 1/23 (4.35%)  1
General disorders     
Death (neonatal) †  1/26 (3.85%)  1 1/23 (4.35%)  1
Admission to NICU (neonatal) †  16/26 (61.54%)  16 13/23 (56.52%)  13
Received Blood Transfusion (maternal) †  1/20 (5.00%)  1 1/22 (4.55%)  1
Infections and infestations     
Necrotizing Enterocolitis (neonatal) †  2/26 (7.69%)  2 0/23 (0.00%)  0
Culture-Positive Sepsis (neonatal) †  3/26 (11.54%)  3 3/23 (13.04%)  3
Nervous system disorders     
Seizures (neonatal) †  0/26 (0.00%)  0 1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders     
Received Mechanical Ventilation (neonatal) †  4/26 (15.38%)  4 3/23 (13.04%)  3
Received Continuous Positive Airway Pressure (CPAP) (neonatal) †  11/26 (42.31%)  11 8/23 (34.78%)  8
Respiratory distress syndrome (RDS) (neonatal) †  10/26 (38.46%)  10 5/23 (21.74%)  5
Vascular disorders     
Intraventricular Hemorrhage (neonatal) †  3/26 (11.54%)  3 2/23 (8.70%)  2
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nifedipine Nifedipine Plus Indomethacin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/46 (8.70%)      4/45 (8.89%)    
Cardiac disorders     
Tachycardia (maternal) †  1/20 (5.00%)  1 1/22 (4.55%)  1
Gastrointestinal disorders     
Acid Reflux (maternal) †  1/20 (5.00%)  1 1/22 (4.55%)  1
General disorders     
Headache (maternal) †  0/20 (0.00%)  0 1/22 (4.55%)  1
Nausea (maternal) †  1/20 (5.00%)  1 0/22 (0.00%)  0
Infections and infestations     
Clinical Chorioamnionitis (maternal) †  1/20 (5.00%)  1 0/22 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Preterm Premature Rupture of Membranes (PPROM) (maternal) †  2/20 (10.00%)  2 2/22 (9.09%)  2
Preeclampsia (maternal) †  1/20 (5.00%)  1 2/22 (9.09%)  2
Vascular disorders     
Hypotension (maternal) †  1/20 (5.00%)  1 1/22 (4.55%)  1
†
Indicates events were collected by systematic assessment
Small sample size
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jerrie S. Refuerzo, MD
Organization: The University of Texas Health Science Center at Houston
Phone: (713) 500-6416
EMail: Jerrie.S.Refuerzo@uth.tmc.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jerrie Refuerzo, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02438371    
Other Study ID Numbers: HSC-MS-15-0134
First Submitted: May 5, 2015
First Posted: May 8, 2015
Results First Submitted: October 25, 2021
Results First Posted: November 24, 2021
Last Update Posted: November 24, 2021