Labor, PrematurePhase 3NCT00641784
Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population
A Phase 3 study testing Magnesium and Nifedlipine in people with Labor, Premature, run by MemorialCare at 1 site in United States.
Trial summary
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Labor, Premature
- What is being tested?
- Magnesium and Nifedlipine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2012
- Phase
- Phase 3
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 240/7-320/7 weeks gestation with findings consistent with preterm labor defined by at least one of the following criteria in accordance with regular uterine contractions (>4 uterine contractions in 20 minutes):
- Cervix > 2 cm in dilation or 80% effaced
- Positive fetal fibronectin (if performed).
- Demonstrated cervical change between two exams within 90 minutes.
Who cannot join
- Negative fetal fibronectin
- > 5cm dilatation
- Multiple gestations
- Known fetal anomalies or chromosomal abnormalities
- Ruptured membranes
- Significant vaginal bleeding
Show all 20Show fewer
- Suspected chorioamnionitis
- Preeclampsia or uncontrolled hypertension
- Non-reassuring fetal heart tracing
- Placenta previa and/or accreta
- Placenta abruption
- Intrauterine growth restriction
- Maternal renal disease
- Underlying maternal cardiac condition
- Symptomatic hyperthyroidism
- Significant maternal disease
- Contraindication to nifedipine or magnesium
- Cerclage presence
- Tocolytic use within the last 12 hours
- Hypotension (defined as average blood pressure of <70/40's unresponsive to 1000 cc fluid bolus
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Care Center for Women/Long Beach Memorial Medical Center
Long Beach, California, 92806
About this study
Official title: A Randomized Trial of Oral Nifedipine Versus Intravenous Magnesium Sulfate in the Acute Management of Preterm Labor in Women With Singleton Gestations, Intact Fetal Membranes, and Positive Vaginal Fetal Fibronectin
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
- Conditions
- Labor, Premature
- Being tested
- Magnesium, Nifedlipine
- Keywords
- Composite Early neonatal Outcome, Late Neurological neonatal outcome
- 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.
MagnesiumDrug
Intravenous Magnesium 6 gram load, 3 grams/hr
NifedlipineDrug
Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral Nifedine Receives: Drug: Nifedlipine |
| 2 | Active comparator | Intravenous Magnesium Receives: Drug: Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
Measured: At delivery
Secondary outcomes (3)
To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.
Measured: At Delivery
To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.
Measured: At delivery
To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis
Measured: At discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MemorialCare
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth Chan, MD, Principal investigator, Obstetrix/Memorial CareVineet K Shrivastava, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641784
- Sponsor's protocol ID
- 464-07
- Status last verified
- Sep 2009
- First submitted
- 19 Mar 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- 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 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Oral Nifedipine Versus Intravenous Magnesium Sulfate in the Acute Management of Preterm Labor in Women With Singleton Gestations, Intact Fetal Membranes, and Positive Vaginal Fetal Fibronectin
- ClinicalTrials.gov ID
- NCT00641784
- Acronym / sponsor ID
- 464-07
- Conditions
- Labor, Premature
- Keywords
- Composite Early neonatal Outcome, Late Neurological neonatal outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MemorialCareUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 24 Mar 2008 (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.
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NifedlipineOral Nifedine |
| 2 | Active comparator | Drug: MagnesiumIntravenous Magnesium |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients between 240/7-320/7 weeks gestation with findings consistent with preterm labor defined by at least one of the following criteria in accordance with regular uterine contractions (>4 uterine contractions in 20 minutes):
Key exclusion criteria (20 listed)
- Negative fetal fibronectin
- > 5cm dilatation
- Multiple gestations
- Known fetal anomalies or chromosomal abnormalities
- Ruptured membranes
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 |
|---|---|---|
| MagnesiumIntravenous Magnesium 6 gram load, 3 grams/hr | Drug | 2 |
| NifedlipineOral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs | Drug | 1 |
Primary outcome
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
Time frame: At delivery
3 secondary outcomes
To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.
Time frame: At Delivery
To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.
Time frame: At delivery
To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis
Time frame: At discharge
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
- 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.
Kenneth Chan, MD principal investigator
Obstetrix/Memorial Care
Vineet K Shrivastava, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium and Nifedlipine in people with Labor, Premature, run by MemorialCare 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 20 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 18 Sep 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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. 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?
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures (time frame: At delivery). 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 NCT00641784, 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 18 Sep 2009.