An interventional study of Magnesium Sulfate and Normal Saline in Abruptio Placentae, sponsored by Stanford University. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-02.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.
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.
23 studies on the registry are indexed under Abruptio Placentae; 4 are open to participants now.
This study's enrollment of 30 is below the median of 142 across 10 interventional studies indexed under Abruptio Placentae.
Browse Abruptio Placentae studies →Stanford University is the lead sponsor of 2,169 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
Drug: Magnesium Sulfate
Normal Saline 4 gram bolus, followed by 2 grams per hour
Other: Normal Saline
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.
Also known as: Active study drug
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.
Also known as: Normal Saline infusion as placebo
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
Gestational Age at Delivery (Weeks)
Median gestational age at delivery (in full weeks)
Time frame: Time of delivery
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
| Milestone | Magnesium Sulfate | Normal Saline |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.
| participants | Magnesium Sulfate | Normal Saline |
|---|---|---|
| Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours | 12 | 10 |
Median gestational age at delivery (in full weeks)
| weeks of gestation | Magnesium Sulfate | Normal Saline |
|---|---|---|
| Gestational Age at Delivery (Weeks) | 36 (32 to 38) | 38 (33 to 39) |
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.
| Apgar score | Magnesium Sulfate | Normal Saline |
|---|---|---|
| Neonatal Apgar Score at 5 Minutes | 9 (9 to 9) | 9 (9 to 9) |
Collected over The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Magnesium Sulfate | — | 0/15 (0%) | 2/15 (13.3%) |
| Normal Saline | — | 0/15 (0%) | 3/15 (20%) |
| Event | Magnesium Sulfate | Normal Saline |
|---|---|---|
| FlushingSkin and subcutaneous tissue disorders | 0/15 | 2/15 |
| LethargyNervous system disorders | 0/15 | 1/15 |
| HeadacheNervous system disorders | 1/15 | 0/15 |
| DizzinessNervous system disorders | 1/15 | 0/15 |
| Age, Continuous(years) | Magnesium Sulfate | Normal Saline | Total |
|---|---|---|---|
| Mean | 29.2 ± 7.2 | 26.4 ± 6.3 | 27.8 ± 6.8 |
| Sex: Female, Male(Participants) | Magnesium Sulfate | Normal Saline | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 0 | 0 | 0 |
| Parity(participants) | Magnesium Sulfate | Normal Saline | Total |
|---|---|---|---|
| Nulliparous | 2 | 5 | 7 |
| Multiparous | 13 | 10 | 23 |
| Gestational age at randomization (weeks)(weeks of gestation) | Magnesium Sulfate | Normal Saline | Total |
|---|---|---|---|
| Median | 30 (28 to 32) | 30 (25 to 31) | 30 (25 to 32) |
| Placental location(participants) | Magnesium Sulfate | Normal Saline | Total |
|---|---|---|---|
| Anterior | 4 | 7 | 11 |
| Posterior | 9 | 6 | 15 |
| Fundal | 1 | 2 | 3 |
| Lateral | 1 | 0 | 1 |
| Vaginal bleeding before study drug administered(participants) | Magnesium Sulfate | Normal Saline | Total |
|---|---|---|---|
| Mild | 11 | 11 | 22 |
| Moderate | 4 | 4 | 8 |
| Heavy | 0 | 0 | 0 |
Plan to share: Undecided
The record gives a start of Mar 2004, a primary completion of Jun 2014 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2017, 2 years 10 months after primary completion.
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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate