Labor, PrematurePhase 4NCT00116623
Magnesium Sulfate Versus Indomethacin for Preterm Labor
A Phase 4 study testing Indomethacin and Magnesium sulfate in people with Labor, Premature, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of Indomethacin compared to Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind randomized clinical trial. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Premature
- What is being tested?
- Indomethacin and Magnesium sulfate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Feb 2006
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Initial episode of preterm labor for enrollment
- The diagnosis of preterm labor
- Gestational age between 24 and 32 weeks
- Singleton or twin gestation
- The ability to understand the requirements of the study
Who cannot join
- Cervical dilation >5 cms
- Suspected chorioamnionitis
- Fetal distress
- Vaginal bleeding
- Severe pre-eclampsia
- History of gastrointestinal bleeding
Show all 11Show fewer
- Abnormal renal function
- Suspicion of fetal malformation by ultrasound
- Known allergy to, or intolerance of, Magnesium sulfate and/or Indomethacin
- Documented rupture of amniotic membranes
- Multiple gestations of triplets or more.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to investigate the efficacy of Indomethacin compared to Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind randomized clinical trial. The specific aim of the project is to test the hypothesis that Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with major complications or death.
- Conditions
- Labor, Premature
- Being tested
- Indomethacin, Magnesium sulfate
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndomethacinDrug
Magnesium sulfateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startFeb 2003
- Primary completionFeb 2006
- Study completionFeb 2006
Why it stopped: Funding completed
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 Labor, PrematureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- George A Macones, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116623
- Sponsor's protocol ID
- 704914
- Status last verified
- Aug 2016
- First submitted
- 29 Jun 2005
- Last updated
- 15 Aug 2016
- Results posted
- No
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 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate Versus Indomethacin for Preterm Labor
- ClinicalTrials.gov ID
- NCT00116623
- Acronym / sponsor ID
- 704914
- Conditions
- Labor, Premature
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding completed
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 30 Jun 2005 (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.
The purpose of this study is to investigate the efficacy of Indomethacin compared to Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind randomized clinical trial. The specific aim of the project is to test the hypothesis that Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with major complications or death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Initial episode of preterm labor for enrollment
- The diagnosis of preterm labor
- Gestational age between 24 and 32 weeks
- Singleton or twin gestation
- The ability to understand the requirements of the study
Key exclusion criteria (11 listed)
- Cervical dilation >5 cms
- Suspected chorioamnionitis
- Fetal distress
- Vaginal bleeding
- Severe pre-eclampsia
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 |
|---|---|---|
| Indomethacin | Drug | – |
| Magnesium sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Funding completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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.
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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.
George A Macones, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indomethacin and Magnesium sulfate in people with Labor, Premature, run by University of Pennsylvania 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 5 inclusion and 11 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 15 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding completed). 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00116623, 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 15 Aug 2016.