Obstetric Labor, PrematureNCT00185900

Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

A study testing Magnesium Sulfate and Nifedipine in people with Obstetric Labor, Premature, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Obstetric Labor, Premature
What is being tested?: Magnesium Sulfate and Nifedipine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 1 siteUnited States
Study dates: Apr 1999to Jul 2007
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

Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

Conditions: Obstetric Labor, Premature
Being tested: Magnesium Sulfate, Nifedipine
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.

Magnesium SulfateDrug
Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.
NifedipineDrug
Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Study groups in NCT00185900
Study group	Role	What they receive
Magnesium Sulfate	Active comparator	Preterm labor treatment with Magnesium Sulfate. Receives: Drug: Magnesium Sulfate
Nifedipine	Active comparator	Preterm labor treatment with Nifedipine. Receives: Drug: Nifedipine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence
Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.
Measured: 48 hours after administration of study medication.

Secondary outcomes (5)

Time to Uterine Quiescence
Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.
Measured: Until delivery, up to 42 weeks of gestation
Gestational Age at Delivery
Presented as weeks
Measured: Until delivery, up to 42 weeks of gestation
Neonatal Birth Weight
Presented as grams
Measured: Until delivery, up to 42 weeks of gestation
Serious Maternal Adverse Effect
A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.
Measured: From study enrollment until discharge from delivery hospital, up to 30 days after delivery.
Composite Neonatal Morbidity
Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.
Measured: From delivery until discharge from the hospital, up to 30 days of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 1999Jul 2007

First posted16 Sep 2005 (estimated)
Study startApr 1999
Primary completionJul 2005
Study completionJul 2007

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 (2)Papers the sponsor has linked to this study.
Other trials for Obstetric Labor, PrematureStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00185900
Sponsor's protocol ID: 76145
Status last verified: Oct 2018
First submitted: 12 Sep 2005
Last updated: 19 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Lyell DJ, Pullen K, Campbell L, Ching S, Druzin ML, Chitkara U, Burrs D, Caughey AB, El-Sayed YY. Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):61-7. doi: 10.1097/01.AOG.0000269048.06634.35.
PubMed 17601897
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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RecruitingObservational study
Growing Little PEAPODS Study
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All Obstetric Labor, Premature trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
ClinicalTrials.gov ID: NCT00185900
Acronym / sponsor ID: 76145
Conditions: Obstetric Labor, Premature
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Apr 1999
Primary completion: Jul 2005 (actual)
Study completion: Jul 2007 (actual)
First posted: 16 Sep 2005 (estimated)
Results: Posted 2 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

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 SulfatePreterm labor treatment with Magnesium Sulfate.
Nifedipine	Active comparator	Drug: NifedipinePreterm labor treatment with Nifedipine.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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 SulfatePreterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.	Drug	Magnesium Sulfate
NifedipinePreterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.	Drug	Nifedipine

Primary outcome

Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence
Time frame: 48 hours after administration of study medication.
Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.

5 secondary outcomes

Time to Uterine Quiescence
Time frame: Until delivery, up to 42 weeks of gestation
Gestational Age at Delivery
Time frame: Until delivery, up to 42 weeks of gestation
Neonatal Birth Weight
Time frame: Until delivery, up to 42 weeks of gestation
Serious Maternal Adverse Effect
Time frame: From study enrollment until discharge from delivery hospital, up to 30 days after delivery.
Composite Neonatal Morbidity
Time frame: From delivery until discharge from the hospital, up to 30 days of age

Results and safety

Results posted to the registry on 2 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Magnesium Sulfate	92	92
Nifedipine	100	100

Primary outcome: Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence

Time frame: 48 hours after administration of study medication.. Count of participants. Unit: Participants

Measure	Magnesium Sulfate n = 92	Nifedipine n = 100
Value	80	72

Magnesium Sulfate vs Nifedipine: p = 0.01, Chi-squared

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study enrollment until discharge from the delivery hospital, up to 30 days after delivery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Magnesium Sulfate	25 of 92 (27.2%)	29 of 92 (31.5%)	0 of 92
Nifedipine	12 of 100 (12%)	22 of 100 (22%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 17601897Lyell DJ, Pullen K, Campbell L, Ching S, Druzin ML, Chitkara U, Burrs D, Caughey AB, El-Sayed YY. Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):61-7. doi: 10.1097/01.AOG.0000269048.06634.35.
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.
Obstet Gynecol. 2007 Jul;110(1):61-7.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Obstetric Labor, Premature

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant

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 Yehia El-Sayed principal investigator

Stanford University

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 and Nifedipine in people with Obstetric Labor, Premature, run by Stanford University 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?

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 19 Nov 2018. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2018). 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?

Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence (time frame: 48 hours after administration of study medication.). 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 NCT00185900, which also lists 2 linked publications.

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 Nov 2018.