Abruptio Placentae
Conditions
Brief summary
To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.
Detailed description
We hope to learn if there is a difference in the efficacy of intravenous magnesium sulfate versus intravenous saline infusion in the resolution of vaginal bleeding and contractions in patients with a suspected placental abruption.
Interventions
DRUGMagnesium Sulfate
Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion.
OTHERNormal Saline
Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion.
Sponsors
Santa Clara Valley Medical Center
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.
Exclusion criteria
\- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours | 48 hours after the randomization | The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Age at Delivery (Weeks) | Time of delivery | Median gestational age at delivery (in full weeks) |
| Neonatal Apgar Score at 5 Minutes | At 5 minutes after birth | The median Apgar score at 5 minutes. Apgar score scale is from 0 to 10 with score 0 expressing the worst neonatal status and score 10 the best status. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Magnesium Sulfate Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion. | 15 |
| Normal Saline Normal Saline 4 gram bolus, followed by 2 grams per hour
Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Normal Saline | Total | Magnesium Sulfate |
|---|---|---|---|
| Age, Continuous | 26.4 years STANDARD_DEVIATION 6.3 | 27.8 years STANDARD_DEVIATION 6.8 | 29.2 years STANDARD_DEVIATION 7.2 |
| Gestational age at randomization (weeks) | 30 weeks of gestation | 30 weeks of gestation | 30 weeks of gestation |
| Parity Multiparous | 10 participants | 23 participants | 13 participants |
| Parity Nulliparous | 5 participants | 7 participants | 2 participants |
| Placental location Anterior | 7 participants | 11 participants | 4 participants |
| Placental location Fundal | 2 participants | 3 participants | 1 participants |
| Placental location Lateral | 0 participants | 1 participants | 1 participants |
| Placental location Posterior | 6 participants | 15 participants | 9 participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Vaginal bleeding before study drug administered Heavy | 0 participants | 0 participants | 0 participants |
| Vaginal bleeding before study drug administered Mild | 11 participants | 22 participants | 11 participants |
| Vaginal bleeding before study drug administered Moderate | 4 participants | 8 participants | 4 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 15 | 3 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours
The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.
Time frame: 48 hours after the randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magnesium Sulfate | Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours | 12 participants |
| Normal Saline | Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours | 10 participants |
p-value: 0.6895% CI: [0.77, 1.86]Fisher Exact
Secondary
Gestational Age at Delivery (Weeks)
Median gestational age at delivery (in full weeks)
Time frame: Time of delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium Sulfate | Gestational Age at Delivery (Weeks) | 36 weeks of gestation |
| Normal Saline | Gestational Age at Delivery (Weeks) | 38 weeks of gestation |
p-value: 0.52Wilcoxon (Mann-Whitney)
Secondary
Neonatal Apgar Score at 5 Minutes
The median Apgar score at 5 minutes. Apgar score scale is from 0 to 10 with score 0 expressing the worst neonatal status and score 10 the best status.
Time frame: At 5 minutes after birth
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium Sulfate | Neonatal Apgar Score at 5 Minutes | 9 Apgar score |
| Normal Saline | Neonatal Apgar Score at 5 Minutes | 9 Apgar score |
p-value: 0.95Fisher Exact