Preterm Labor
Conditions
Keywords
pregnancy, preterm labor, tocolysis
Brief summary
Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
Detailed description
The investigators current treatment for preterm labor has not been shown to be effective in prolonging pregnancy sufficiently to improve neonatal outcomes and other treatment strategies are needed. Multiple examples demonstrate that multi-agent treatments are routine clinical practice in other fields of medicine including chemotherapeutics for cancer, multi-therapeutics for myocardial infarction and broad spectrum antibiotics for pneumonia. At this time, it is unclear if a combination of tocolytic medications for preterm labor is more advantageous for women. If pregnancy is prolonged with combined tocolytic therapy, this could directly influence the treatment of preterm labor and potentially improve neonatal outcomes. There currently are no trials of combination regimens using widely used tocolytic agents, such as nifedipine and indomethacin. Thus, we propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
Interventions
DRUGNifedipine
DRUGIndomethacin
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* We will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following: * cervical change of at least 1 cm or * cervical dilation of 2 cm at the time of initial exam or * positive fetal fibronectin and transvaginal cervical length \<2.5 cm
Exclusion criteria
* We will exclude pregnant women with any contraindication to tocolysis: * clinical chorioamnionitis (defined as a temperature of \>100.4 F and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge) * non reassuring fetal heart tones * suspected placental abruption * preterm premature rupture of membranes * prior tocolytic treatment during the past 48 hours * known adverse effect to indomethacin or nifedipine * already receiving nifedipine for chronic hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation | 48 hours after administration of tocolytic agent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days From First Dose of Tocolytic Agent to Delivery | from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months) | Length of time from tocolytic initiation to the time of delivery |
| Neonatal Birthweight | at the time of birth | — |
| Neonatal Sex | at the time of birth | — |
| Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU) | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Neonatal Length of Stay in NICU | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Neonatal Length of Hospital Stay | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Number of Neonatal Deaths | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Number of Neonates With Necrotizing Enterocolitis | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Number of Neonates With Culture-positive Sepsis | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Number of Neonates With Seizures | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Number of Neonates Who Needed Mechanical Ventilation | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Neonatal Duration of Ventilator Use | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
| Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation | 7 days after administration of tocolytic agent | — |
| Number of Maternal Participants Who Delivered by Cesarean Delivery | at the the time of birth | — |
| Number of Maternal Participants Who Had Clinical Chorioamnionitis | from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months) | — |
| Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM) | from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months) | — |
| Number of Maternal Participants Who Had Preeclampsia | from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months) | — |
| Number of Maternal Participants Who Needed Blood Transfusion | from time of birth to time of discharge from hospital (about 2-3 days) | — |
| Number of Maternal Participants With Headache | from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) | — |
| Number of Maternal Participants With Nausea | from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) | — |
| Number of Maternal Participants With Vomiting | from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) | — |
| Number of Maternal Participants With Acid Reflux | from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) | — |
| Number of Maternal Participants With Hypotension | from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) | — |
| Number of Maternal Participants With Tachycardia | from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) | — |
| Number of Maternal Participants With Syncope | from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) | — |
| Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP) | from birth until hospital discharge or day 120 of life (whichever occurs first) | — |
Countries
United States
Participant flow
Pre-assignment details
The numbers listed in the Participant Flow section correspond to maternal participants.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 22 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Nifedipine Plus Indomethacin | Total | Nifedipine |
|---|---|---|---|
| Age, Continuous | 28.5 years STANDARD_DEVIATION 7.7 | 28.3 years STANDARD_DEVIATION 7.6 | 28.0 years STANDARD_DEVIATION 7.5 |
| Race/Ethnicity, Customized African/African American/Black American | 15 Participants | 24 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants | 13 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 4 Participants | 3 Participants |
| Region of Enrollment United States | 22 Participants | 42 Participants | 20 Participants |
| Sex: Female, Male Female | 22 Participants | 42 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 46 | 1 / 45 |
| other Total, other adverse events | 4 / 46 | 4 / 45 |
| serious Total, serious adverse events | 24 / 46 | 38 / 45 |
Outcome results
Primary
Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation
Time frame: 48 hours after administration of tocolytic agent
Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation | 15 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation | 20 Participants |
Secondary
Neonatal Birthweight
Time frame: 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.)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nifedipine | Neonatal Birthweight | 1870.0 grams |
| Nifedipine Plus Indomethacin | Neonatal Birthweight | 2571.0 grams |
Secondary
Neonatal Duration of Ventilator Use
Time frame: 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.)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nifedipine | Neonatal Duration of Ventilator Use | 32.5 hours |
| Nifedipine Plus Indomethacin | Neonatal Duration of Ventilator Use | 186.0 hours |
Secondary
Neonatal Length of Hospital Stay
Time frame: 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.)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nifedipine | Neonatal Length of Hospital Stay | 31.8 days |
| Nifedipine Plus Indomethacin | Neonatal Length of Hospital Stay | 10.9 days |
Secondary
Neonatal Length of Stay in NICU
Time frame: 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.)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nifedipine | Neonatal Length of Stay in NICU | 36.3 days |
| Nifedipine Plus Indomethacin | Neonatal Length of Stay in NICU | 25.3 days |
Secondary
Neonatal Sex
Time frame: 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.)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifedipine | Neonatal Sex | Female | 6 Participants |
| Nifedipine | Neonatal Sex | Male | 16 Participants |
| Nifedipine Plus Indomethacin | Neonatal Sex | Female | 9 Participants |
| Nifedipine Plus Indomethacin | Neonatal Sex | Male | 14 Participants |
Secondary
Number of Days From First Dose of Tocolytic Agent to Delivery
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)
Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nifedipine | Number of Days From First Dose of Tocolytic Agent to Delivery | 24.8 days |
| Nifedipine Plus Indomethacin | Number of Days From First Dose of Tocolytic Agent to Delivery | 42.6 days |
Secondary
Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation
Time frame: 7 days after administration of tocolytic agent
Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation | 12 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation | 18 Participants |
Secondary
Number of Maternal Participants Who Delivered by Cesarean Delivery
Time frame: at the the time of birth
Population: Data for this outcome measure were not collected for 4 in the Nifedipine arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants Who Delivered by Cesarean Delivery | 5 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants Who Delivered by Cesarean Delivery | 5 Participants |
Secondary
Number of Maternal Participants Who Had Clinical Chorioamnionitis
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants Who Had Clinical Chorioamnionitis | 1 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants Who Had Clinical Chorioamnionitis | 0 Participants |
Secondary
Number of Maternal Participants Who Had Preeclampsia
Time frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants Who Had Preeclampsia | 1 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants Who Had Preeclampsia | 2 Participants |
Secondary
Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM)
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM) | 2 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM) | 2 Participants |
Secondary
Number of Maternal Participants Who Needed Blood Transfusion
Time frame: from time of birth to time of discharge from hospital (about 2-3 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants Who Needed Blood Transfusion | 1 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants Who Needed Blood Transfusion | 1 Participants |
Secondary
Number of Maternal Participants With Acid Reflux
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants With Acid Reflux | 1 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants With Acid Reflux | 1 Participants |
Secondary
Number of Maternal Participants With Headache
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants With Headache | 0 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants With Headache | 1 Participants |
Secondary
Number of Maternal Participants With Hypotension
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants With Hypotension | 1 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants With Hypotension | 1 Participants |
Secondary
Number of Maternal Participants With Nausea
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants With Nausea | 1 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants With Nausea | 0 Participants |
Secondary
Number of Maternal Participants With Syncope
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants With Syncope | 0 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants With Syncope | 0 Participants |
Secondary
Number of Maternal Participants With Tachycardia
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants With Tachycardia | 1 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants With Tachycardia | 1 Participants |
Secondary
Number of Maternal Participants With Vomiting
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Maternal Participants With Vomiting | 0 Participants |
| Nifedipine Plus Indomethacin | Number of Maternal Participants With Vomiting | 0 Participants |
Secondary
Number of Neonatal Deaths
Time frame: 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.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Neonatal Deaths | 1 Participants |
| Nifedipine Plus Indomethacin | Number of Neonatal Deaths | 1 Participants |
Secondary
Number of Neonates Who Needed Mechanical Ventilation
Time frame: 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.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Neonates Who Needed Mechanical Ventilation | 4 Participants |
| Nifedipine Plus Indomethacin | Number of Neonates Who Needed Mechanical Ventilation | 3 Participants |
Secondary
Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP)
Time frame: 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.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP) | 11 Participants |
| Nifedipine Plus Indomethacin | Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP) | 8 Participants |
Secondary
Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: 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.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU) | 16 Participants |
| Nifedipine Plus Indomethacin | Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU) | 13 Participants |
Secondary
Number of Neonates With Culture-positive Sepsis
Time frame: 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.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Neonates With Culture-positive Sepsis | 3 Participants |
| Nifedipine Plus Indomethacin | Number of Neonates With Culture-positive Sepsis | 3 Participants |
Secondary
Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography
Time frame: 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.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography | 3 Participants |
| Nifedipine Plus Indomethacin | Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography | 2 Participants |
Secondary
Number of Neonates With Necrotizing Enterocolitis
Time frame: 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.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Neonates With Necrotizing Enterocolitis | 2 Participants |
| Nifedipine Plus Indomethacin | Number of Neonates With Necrotizing Enterocolitis | 0 Participants |
Secondary
Number of Neonates With Seizures
Time frame: 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.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine | Number of Neonates With Seizures | 0 Participants |
| Nifedipine Plus Indomethacin | Number of Neonates With Seizures | 1 Participants |