Abruptio PlacentaeNCT00186069
Magnesium Sulfate vs Placebo for Placental Abruption
A study testing Magnesium Sulfate and Normal Saline in people with Abruptio Placentae, run by Stanford University at 2 sites in United States.
Trial summary
To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abruptio Placentae
- What is being tested?
- Magnesium Sulfate and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2004to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.
Who cannot join
- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Santa Clara Valley Medical Center
San Jose, California, 95128
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption
To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.
Read the 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.
- Conditions
- Abruptio Placentae
- Being tested
- Magnesium Sulfate, Normal Saline
- Medical subject headings
- Abruptio Placentae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called Active study drug
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 SalineOther
Also called Normal Saline infusion as placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate | Active comparator | Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour Receives: Drug: Magnesium Sulfate |
| Normal Saline | Placebo comparator | Normal Saline 4 gram bolus, followed by 2 grams per hour Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after the randomization
Secondary outcomes (2)
Gestational Age at Delivery (Weeks)
Median gestational age at delivery (in full weeks)
Measured: 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.
Measured: At 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionJun 2014
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abruptio PlacentaeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Clara Valley Medical Center
- Responsible party
- Principal investigator, Yasser Yehia El-Sayed, Stanford University
- Investigators
- Yasser Y El-Sayed, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186069
- Sponsor's protocol ID
- 79811
- Status last verified
- Dec 2017
- First submitted
- 13 Sep 2005
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Colon I, Berletti M, Garabedian MJ, Wilcox N, Williams K, El-Sayed YY, Chueh J. Randomized, Double-Blinded Trial of Magnesium Sulfate Tocolysis versus Intravenous Normal Saline for Preterm Nonsevere Placental Abruption. Am J Perinatol. 2016 Jun;33(7):696-702. doi: 10.1055/s-0036-1571324. Epub 2016 Feb 12.
PubMed 26871905
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption
- ClinicalTrials.gov ID
- NCT00186069
- Acronym / sponsor ID
- 79811
- Conditions
- Abruptio Placentae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Santa Clara Valley Medical Center
- Study start
- Mar 2004
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 20 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate | Active comparator | Drug: Magnesium SulfateMagnesium Sulfate 4 gram bolus, followed by 2 grams per hour |
| Normal Saline | Placebo comparator | Other: Normal SalineNormal Saline 4 gram bolus, followed by 2 grams per hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.
Key exclusion criteria (1 listed)
- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateAlso: Active study drugMagnesium 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. | Drug | Magnesium Sulfate |
| Normal SalineAlso: Normal Saline infusion as placeboNormal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion. | Other | Normal Saline |
Primary outcome
Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours
Time frame: 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.
2 secondary outcomes
Gestational Age at Delivery (Weeks)
Time frame: Time of delivery
Neonatal Apgar Score at 5 Minutes
Time frame: At 5 minutes after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26871905Colon I, Berletti M, Garabedian MJ, Wilcox N, Williams K, El-Sayed YY, Chueh J. Randomized, Double-Blinded Trial of Magnesium Sulfate Tocolysis versus Intravenous Normal Saline for Preterm Nonsevere Placental Abruption. Am J Perinatol. 2016 Jun;33(7):696-702. doi: 10.1055/s-0036-1571324. Epub 2016 Feb 12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Y El-Sayed, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and Normal Saline in people with Abruptio Placentae, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours (time frame: 48 hours after the randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00186069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.