Preterm Premature Rupture of MembranesNCT00463736
Magnesium Sulfate Versus Placebo for Tocolysis in PPROM
A study testing Magnesium sulfate in people with Preterm Premature Rupture of Membranes, run by Regional Obstetrical Consultants at 1 site in United States.
Trial summary
Study compares the outcomes of women between 26 and 32 wks gestation with rupture of membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Premature Rupture of Membranes
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English or Spanish speaking
- preterm premature rupture of membranes
- 26 - 32.6 weeks gestation
- cervical dilation </= 4 cm
Who cannot join
- suspected intrauterine or intraamniotic infection
- > 6 hours of tocolysis prior to admission
- positive fetal lung maturity
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Obstetrical Consultants
Chattanooga, Tennessee, 37403
About this study
Official title: Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes
Study compares the outcomes of women between 26 and 32 wks gestation with rupture of membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups.
Read the detailed description
The majority of studies of the effectiveness of tocolysis with PPROM were in the 1980s prior to the commmon usage of antenatal steroids and prophylactic maternal antibiotics. In most studies, tocolysis was not attempted prior to the onset of labor in this group of women. The ACOG Practice Bulletin of June 1998 concedes that the recommendation of tocolysis to permit administration of steroids and maternal antibiotics is based primarily upon consensus, not consistent scientific evidence.
The purpose of this study, which will randomize 128 subjects to tocolysis or no tocolysis, is to prospectively assess whether short term (48 hr) tocolysis affords benefit to women and babies between 26 and 32 weeks gestation with PPROM.
Subjects will be enrolled at 1-2 high risk hospitals in Chattanooga and Knoxville. All English and Spanish speaking women 18-45 years with PPROM and cervical dilation <4 will be eligible. Women with suspected intrauterine infection, positive fetal lung maturity, or > 6 hours tocolysis at time of admission will be excluded.
Both groups of women will receive continuous fetal monitoring, antibiotics, and antenatal steroids (if not previously administered). Both groups will be evaluated every 2-4 hours for fetal and maternal well being. Both groups will receive IVF at 125cc/hr, and the treatment group will be loaded with 4 grams of magnesium sulfate and receive maintainence dose of 2 grams/hr x 48 hrs.
- Conditions
- Preterm Premature Rupture of Membranes
- Being tested
- Magnesium sulfate
- Keywords
- short term tocolysis, preterm premature rupture of membranes
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate | Active comparator | x 48 hours IV Receives: Drug: Magnesium sulfate |
| Normal saline | Placebo comparator | x 48 hours IV Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
hours of latency to delivery
from start of study drug to delivery
Measured: 0 hours to > 168 hours
Secondary outcomes (5)
maternal postpartum length of stay
from start of study drug to delivery
Measured: 0 hours to > 168 hours
maternal infection rates
from start of study drug to maternal discharge from hospital
Measured: 0 hours to > 168 hours
neonatal ventilator days
from delivery to 28 days of life
Measured: 0 to 28 days
neonatal early onset infection
from delivery to 28 days of life
Measured: 0 to 28 days
neonatal length of stay
from delivery to 28 days of life
Measured: 0 to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: enrollment proceeding too slowly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm Premature Rupture of MembranesStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Obstetrical Consultants
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorrie Mason, Regional Obstetrical Consultants
- Investigators
- Christian M Briery, MD, Principal investigator, Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463736
- Sponsor's protocol ID
- 07-006
- Status last verified
- Aug 2016
- First submitted
- 19 Apr 2007
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
PubMed 35947046
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT00463736
- Acronym / sponsor ID
- 07-006
- Conditions
- Preterm Premature Rupture of Membranes
- Keywords
- short term tocolysis, preterm premature rupture of membranes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment proceeding too slowly
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Regional Obstetrical ConsultantsUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study compares the outcomes of women between 26 and 32 wks gestation with rupture of membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups.
Detailed description
The majority of studies of the effectiveness of tocolysis with PPROM were in the 1980s prior to the commmon usage of antenatal steroids and prophylactic maternal antibiotics. In most studies, tocolysis was not attempted prior to the onset of labor in this group of women. The ACOG Practice Bulletin of June 1998 concedes that the recommendation of tocolysis to permit administration of steroids and maternal antibiotics is based primarily upon consensus, not consistent scientific evidence.
The purpose of this study, which will randomize 128 subjects to tocolysis or no tocolysis, is to prospectively assess whether short term (48 hr) tocolysis affords benefit to women and babies between 26 and 32 weeks gestation with PPROM.
Subjects will be enrolled at 1-2 high risk hospitals in Chattanooga and Knoxville. All English and Spanish speaking women 18-45 years with PPROM and cervical dilation <4 will be eligible. Women with suspected intrauterine infection, positive fetal lung maturity, or > 6 hours tocolysis at time of admission will be excluded.
Both groups of women will receive continuous fetal monitoring, antibiotics, and antenatal steroids (if not previously administered). Both groups will be evaluated every 2-4 hours for fetal and maternal well being. Both groups will receive IVF at 125cc/hr, and the treatment group will be loaded with 4 grams of magnesium sulfate and receive maintainence dose of 2 grams/hr x 48 hrs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate | Active comparator | Drug: Magnesium sulfatex 48 hours IV |
| Normal saline | Placebo comparator | Drug: Magnesium sulfatex 48 hours IV |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- English or Spanish speaking
- preterm premature rupture of membranes
- 26 - 32.6 weeks gestation
- cervical dilation </= 4 cm
Key exclusion criteria (3 listed)
- suspected intrauterine or intraamniotic infection
- > 6 hours of tocolysis prior to admission
- positive fetal lung maturity
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 sulfate | Drug | Magnesium sulfate, Normal saline |
Primary outcome
hours of latency to delivery
Time frame: 0 hours to > 168 hours
from start of study drug to delivery
5 secondary outcomes
maternal postpartum length of stay
Time frame: 0 hours to > 168 hours
maternal infection rates
Time frame: 0 hours to > 168 hours
neonatal ventilator days
Time frame: 0 to 28 days
neonatal early onset infection
Time frame: 0 to 28 days
neonatal length of stay
Time frame: 0 to 28 days
Results and safety
The study was stopped early (reason given: enrollment proceeding too slowly). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Derived from this study: PubMed 35947046Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
- 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.
Christian M Briery, MD principal investigator
Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate in people with Preterm Premature Rupture of Membranes, run by Regional Obstetrical Consultants at 1 site 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: enrollment proceeding too slowly). Results are not available in the source record.
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?
hours of latency to delivery (time frame: 0 hours to > 168 hours). 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 NCT00463736, 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 19 Aug 2016.