Obstetric Labor, Premature
Conditions
Brief summary
To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor
Interventions
DRUGMagnesium Sulfate
Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.
DRUGNifedipine
Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
:- Uterine contractions and cervical change or ruptured membranes in a preterm gestation
Exclusion criteria
- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence | 48 hours after administration of study medication. | Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Uterine Quiescence | Until delivery, up to 42 weeks of gestation | Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change. |
| Gestational Age at Delivery | Until delivery, up to 42 weeks of gestation | Presented as weeks |
| Neonatal Birth Weight | Until delivery, up to 42 weeks of gestation | Presented as grams |
| Serious Maternal Adverse Effect | From study enrollment until discharge from delivery hospital, up to 30 days after delivery. | A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension. |
| Composite Neonatal Morbidity | From delivery until discharge from the hospital, up to 30 days of age | Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Magnesium Sulfate Preterm labor treatment with Magnesium Sulfate.
Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician. | 92 |
| Nifedipine Preterm labor treatment with Nifedipine.
Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours. | 100 |
| Total | 192 |
Baseline characteristics
| Characteristic | Magnesium Sulfate | Nifedipine | Total |
|---|---|---|---|
| Age, Continuous | 26.6 years STANDARD_DEVIATION 6.8 | 26.3 years STANDARD_DEVIATION 6.3 | 26.5 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment United States | 92 participants | 100 participants | 192 participants |
| Sex: Female, Male Female | 92 Participants | 100 Participants | 192 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 | 0 / 92 | 0 / 100 |
| other Total, other adverse events | 29 / 92 | 22 / 100 |
| serious Total, serious adverse events | 25 / 92 | 12 / 100 |
Outcome results
Primary
Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence
Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.
Time frame: 48 hours after administration of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Magnesium Sulfate | Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence | 80 Participants |
| Nifedipine | Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence | 72 Participants |
p-value: 0.01Chi-squared
Secondary
Composite Neonatal Morbidity
Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.
Time frame: From delivery until discharge from the hospital, up to 30 days of age
Population: Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Magnesium Sulfate | Composite Neonatal Morbidity | 27 Participants |
| Nifedipine | Composite Neonatal Morbidity | 22 Participants |
Secondary
Gestational Age at Delivery
Presented as weeks
Time frame: Until delivery, up to 42 weeks of gestation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Sulfate | Gestational Age at Delivery | 35.8 weeks | Standard Deviation 3.4 |
| Nifedipine | Gestational Age at Delivery | 36.0 weeks | Standard Deviation 3.1 |
Secondary
Neonatal Birth Weight
Presented as grams
Time frame: Until delivery, up to 42 weeks of gestation
Population: Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Sulfate | Neonatal Birth Weight | 2550 grams | Standard Deviation 802 |
| Nifedipine | Neonatal Birth Weight | 2650 grams | Standard Deviation 698 |
Secondary
Serious Maternal Adverse Effect
A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.
Time frame: From study enrollment until discharge from delivery hospital, up to 30 days after delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Magnesium Sulfate | Serious Maternal Adverse Effect | 20 Participants |
| Nifedipine | Serious Maternal Adverse Effect | 10 Participants |
Secondary
Time to Uterine Quiescence
Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.
Time frame: Until delivery, up to 42 weeks of gestation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Sulfate | Time to Uterine Quiescence | 8.4 hours | Standard Deviation 6.5 |
| Nifedipine | Time to Uterine Quiescence | 6.1 hours | Standard Deviation 6.3 |