Trial Outcomes & Findings for Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor (NCT NCT02438371)

NCT ID: NCT02438371

Last Updated: 2021-11-24

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 49 participants
• Primary outcome timeframe: 48 hours after administration of tocolytic agent
• Results posted on: 2021-11-24

Participant Flow

The numbers listed in the Participant Flow section correspond to maternal participants.

Participant milestones

Measure	Nifedipine 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.	Nifedipine Plus Indomethacin 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 Study STARTED	24	25
Overall Study Received Intervention	24	25
Overall Study COMPLETED	20	22
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Nifedipine 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.	Nifedipine Plus Indomethacin 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 Study Lost to Follow-up	3	2
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

Baseline characteristics by cohort

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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 n=42 Participants Total of all reporting groups
Age, Continuous	28.0 years STANDARD_DEVIATION 7.5 • n=5 Participants	28.5 years STANDARD_DEVIATION 7.7 • n=7 Participants	28.3 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	42 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 African/African American/Black American	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours after administration of tocolytic agent

Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm.

Outcome measures

Measure	Nifedipine n=16 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation	15 Participants	20 Participants

SECONDARY outcome

Timeframe: 7 days after administration of tocolytic agent

Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm.

Outcome measures

Measure	Nifedipine n=16 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation	12 Participants	18 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)

Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm.

Length of time from tocolytic initiation to the time of delivery

Outcome measures

Measure	Nifedipine n=16 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Days From First Dose of Tocolytic Agent to Delivery	24.8 days Interval 6.9 to 49.8	42.6 days Interval 24.1 to 61.8

SECONDARY outcome

Timeframe: at the time of birth

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Neonatal Birthweight	1870.0 grams Interval 1451.2 to 2317.5	2571.0 grams Interval 1733.8 to 3073.8

SECONDARY outcome

Timeframe: at the time of birth

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=23 Participants 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.
Neonatal Sex Female	6 Participants	9 Participants
Neonatal Sex Male	16 Participants	14 Participants

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)	16 Participants	13 Participants

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=16 Participants 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.	Nifedipine Plus Indomethacin n=13 Participants 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.
Neonatal Length of Stay in NICU	36.3 days Interval 26.0 to 46.2	25.3 days Interval 14.0 to 52.2

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Neonatal Length of Hospital Stay	31.8 days Interval 3.0 to 44.7	10.9 days Interval 2.5 to 27.4

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=21 Participants 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.
Number of Neonatal Deaths	1 Participants	1 Participants

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=21 Participants 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.
Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography	3 Participants	2 Participants

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=21 Participants 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.
Number of Neonates With Necrotizing Enterocolitis	2 Participants	0 Participants

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=21 Participants 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.
Number of Neonates With Culture-positive Sepsis	3 Participants	3 Participants

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=21 Participants 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.
Number of Neonates With Seizures	0 Participants	1 Participants

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=22 Participants 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.	Nifedipine Plus Indomethacin n=21 Participants 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.
Number of Neonates Who Needed Mechanical Ventilation	4 Participants	3 Participants

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=4 Participants 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.	Nifedipine Plus Indomethacin n=3 Participants 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.
Neonatal Duration of Ventilator Use	32.5 hours Interval 25.4 to 414.8	186.0 hours Interval 103.0 to 1593.0

SECONDARY outcome

Timeframe: from birth until hospital discharge or day 120 of life (whichever occurs first)

Population: 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.)

Outcome measures

Measure	Nifedipine n=21 Participants 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.	Nifedipine Plus Indomethacin n=21 Participants 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.
Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP)	11 Participants	8 Participants

SECONDARY outcome

Timeframe: at the the time of birth

Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm.

Outcome measures

Measure	Nifedipine n=16 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants Who Delivered by Cesarean Delivery	5 Participants	5 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)

Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm and 1 in the Nifedipine plus Indomethacin arm.

Outcome measures

Measure	Nifedipine n=16 Participants 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.	Nifedipine Plus Indomethacin n=21 Participants 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.
Number of Maternal Participants Who Had Clinical Chorioamnionitis	1 Participants	0 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)

Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm and 1 in the Nifedipine plus Indomethacin arm.

Outcome measures

Measure	Nifedipine n=16 Participants 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.	Nifedipine Plus Indomethacin n=21 Participants 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.
Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM)	2 Participants	2 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)

Outcome measures

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants Who Had Preeclampsia	1 Participants	2 Participants

SECONDARY outcome

Timeframe: from time of birth to time of discharge from hospital (about 2-3 days)

Outcome measures

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants Who Needed Blood Transfusion	1 Participants	1 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)

Outcome measures

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants With Headache	0 Participants	1 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)

Outcome measures

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants With Nausea	1 Participants	0 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)

Outcome measures

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants With Vomiting	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)

Outcome measures

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants With Acid Reflux	1 Participants	1 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)

Outcome measures

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants With Hypotension	1 Participants	1 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)

Outcome measures

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants With Tachycardia	1 Participants	1 Participants

SECONDARY outcome

Timeframe: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)

Outcome measures

Measure	Nifedipine n=20 Participants 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.	Nifedipine Plus Indomethacin n=22 Participants 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.
Number of Maternal Participants With Syncope	0 Participants	0 Participants

Adverse Events

Nifedipine

Serious events: 24 serious events

Other events: 4 other events

Deaths: 1 deaths

Nifedipine Plus Indomethacin

Serious events: 38 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Nifedipine n=46 participants at risk 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.	Nifedipine Plus Indomethacin n=45 participants at risk 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.
General disorders Death (neonatal)	3.8% 1/26 • Number of events 1 • 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 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).	4.3% 1/23 • Number of events 1 • 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 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).
General disorders Admission to NICU (neonatal)	61.5% 16/26 • Number of events 16 • 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 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).	56.5% 13/23 • Number of events 13 • 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 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).
Vascular disorders Intraventricular Hemorrhage (neonatal)	11.5% 3/26 • Number of events 3 • 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 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).	8.7% 2/23 • Number of events 2 • 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 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).
Infections and infestations Necrotizing Enterocolitis (neonatal)	7.7% 2/26 • Number of events 2 • 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 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).	0.00% 0/23 • 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 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).
Infections and infestations Culture-Positive Sepsis (neonatal)	11.5% 3/26 • Number of events 3 • 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 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).	13.0% 3/23 • Number of events 3 • 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 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).
Nervous system disorders Seizures (neonatal)	0.00% 0/26 • 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 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).	4.3% 1/23 • Number of events 1 • 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 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).
Respiratory, thoracic and mediastinal disorders Received Mechanical Ventilation (neonatal)	15.4% 4/26 • Number of events 4 • 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 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).	13.0% 3/23 • Number of events 3 • 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 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).
Respiratory, thoracic and mediastinal disorders Received Continuous Positive Airway Pressure (CPAP) (neonatal)	42.3% 11/26 • Number of events 11 • 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 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).	34.8% 8/23 • Number of events 8 • 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 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).
Respiratory, thoracic and mediastinal disorders Respiratory distress syndrome (RDS) (neonatal)	38.5% 10/26 • Number of events 10 • 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 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).	21.7% 5/23 • Number of events 5 • 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 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).
Eye disorders Retinopathy of prematurity (neonatal)	15.4% 4/26 • Number of events 4 • 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 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).	4.3% 1/23 • Number of events 1 • 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 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).
General disorders Received Blood Transfusion (maternal)	5.0% 1/20 • Number of events 1 • 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 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).	4.5% 1/22 • Number of events 1 • 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 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).

Other adverse events

Measure	Nifedipine n=46 participants at risk 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.	Nifedipine Plus Indomethacin n=45 participants at risk 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.
General disorders Headache (maternal)	0.00% 0/20 • 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 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).	4.5% 1/22 • Number of events 1 • 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 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).
General disorders Nausea (maternal)	5.0% 1/20 • Number of events 1 • 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 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).	0.00% 0/22 • 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 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).
Gastrointestinal disorders Acid Reflux (maternal)	5.0% 1/20 • Number of events 1 • 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 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).	4.5% 1/22 • Number of events 1 • 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 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).
Vascular disorders Hypotension (maternal)	5.0% 1/20 • Number of events 1 • 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 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).	4.5% 1/22 • Number of events 1 • 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 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).
Cardiac disorders Tachycardia (maternal)	5.0% 1/20 • Number of events 1 • 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 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).	4.5% 1/22 • Number of events 1 • 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 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).
Infections and infestations Clinical Chorioamnionitis (maternal)	5.0% 1/20 • Number of events 1 • 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 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).	0.00% 0/22 • 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 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).
Pregnancy, puerperium and perinatal conditions Preterm Premature Rupture of Membranes (PPROM) (maternal)	10.0% 2/20 • Number of events 2 • 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 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).	9.1% 2/22 • Number of events 2 • 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 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).
Pregnancy, puerperium and perinatal conditions Preeclampsia (maternal)	5.0% 1/20 • Number of events 1 • 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 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).	9.1% 2/22 • Number of events 2 • 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 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).

Additional Information

Jerrie S. Refuerzo, MD

The University of Texas Health Science Center at Houston

Phone: (713) 500-6416

Email: Jerrie.S.Refuerzo@uth.tmc.edu

Results disclosure agreements

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