Trial Outcomes & Findings for Magnesium Sulfate vs Placebo for Placental Abruption (NCT NCT00186069)

NCT ID: NCT00186069

Last Updated: 2018-01-02

Results Overview

The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 48 hours after the randomization
• Results posted on: 2018-01-02

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnesium Sulfate vs Placebo for Placental Abruption

Baseline characteristics by cohort

Measure	Magnesium Sulfate n=15 Participants 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.	Normal Saline n=15 Participants 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.	Total n=30 Participants Total of all reporting groups
Age, Continuous	29.2 years STANDARD_DEVIATION 7.2 • n=93 Participants	26.4 years STANDARD_DEVIATION 6.3 • n=4 Participants	27.8 years STANDARD_DEVIATION 6.8 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Parity Nulliparous	2 participants n=93 Participants	5 participants n=4 Participants	7 participants n=27 Participants
Parity Multiparous	13 participants n=93 Participants	10 participants n=4 Participants	23 participants n=27 Participants
Gestational age at randomization (weeks)	30 weeks of gestation n=93 Participants	30 weeks of gestation n=4 Participants	30 weeks of gestation n=27 Participants
Placental location Anterior	4 participants n=93 Participants	7 participants n=4 Participants	11 participants n=27 Participants
Placental location Posterior	9 participants n=93 Participants	6 participants n=4 Participants	15 participants n=27 Participants
Placental location Fundal	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants
Placental location Lateral	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Vaginal bleeding before study drug administered Mild	11 participants n=93 Participants	11 participants n=4 Participants	22 participants n=27 Participants
Vaginal bleeding before study drug administered Moderate	4 participants n=93 Participants	4 participants n=4 Participants	8 participants n=27 Participants
Vaginal bleeding before study drug administered Heavy	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Magnesium Sulfate n=15 Participants 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.	Normal Saline n=15 Participants 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.
Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours	12 participants	10 participants

SECONDARY outcome

Timeframe: Time of delivery

Median gestational age at delivery (in full weeks)

Outcome measures

Measure	Magnesium Sulfate n=15 Participants 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.	Normal Saline n=15 Participants 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.
Gestational Age at Delivery (Weeks)	36 weeks of gestation Interval 32.0 to 38.0	38 weeks of gestation Interval 33.0 to 39.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Magnesium Sulfate n=15 Participants 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.	Normal Saline n=15 Participants 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.
Neonatal Apgar Score at 5 Minutes	9 Apgar score Interval 9.0 to 9.0	9 Apgar score Interval 9.0 to 9.0

Adverse Events

Magnesium Sulfate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Magnesium Sulfate n=15 participants at risk 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.	Normal Saline n=15 participants at risk 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.
Nervous system disorders Lethargy	0.00% 0/15 • The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.	6.7% 1/15 • The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.
Nervous system disorders Headache	6.7% 1/15 • The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.	0.00% 0/15 • The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.
Skin and subcutaneous tissue disorders Flushing	0.00% 0/15 • The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.	13.3% 2/15 • The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.
Nervous system disorders Dizziness	6.7% 1/15 • The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.	0.00% 0/15 • The adverse events were collected while participants were admitted in labor&delivery and in postpartum units.

Additional Information

Anna Girsen, Manager of Research Operations

Stanford University

Phone: (650) 725-5720

Email: agirsen@stanford.edu

Results disclosure agreements

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