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

Primary Purpose

Obstetric Labor, Premature

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnesium Sulfate
Nifedipine
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Labor, Premature

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Magnesium Sulfate

Nifedipine

Arm Description

Preterm labor treatment with Magnesium Sulfate.

Preterm labor treatment with Nifedipine.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Uterine Quiescence
Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.
Gestational Age at Delivery
Presented as weeks
Neonatal Birth Weight
Presented as grams
Serious Maternal Adverse Effect
A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.
Composite Neonatal Morbidity
Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.

Full Information

First Posted
September 12, 2005
Last Updated
October 2, 2018
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00185900
Brief Title
Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
Official Title
Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor, Premature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium Sulfate
Arm Type
Active Comparator
Arm Description
Preterm labor treatment with Magnesium Sulfate.
Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
Preterm labor treatment with Nifedipine.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.
Primary Outcome Measure Information:
Title
Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence
Description
Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.
Time Frame
48 hours after administration of study medication.
Secondary Outcome Measure Information:
Title
Time to Uterine Quiescence
Description
Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.
Time Frame
Until delivery, up to 42 weeks of gestation
Title
Gestational Age at Delivery
Description
Presented as weeks
Time Frame
Until delivery, up to 42 weeks of gestation
Title
Neonatal Birth Weight
Description
Presented as grams
Time Frame
Until delivery, up to 42 weeks of gestation
Title
Serious Maternal Adverse Effect
Description
A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.
Time Frame
From study enrollment until discharge from delivery hospital, up to 30 days after delivery.
Title
Composite Neonatal Morbidity
Description
Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.
Time Frame
From delivery until discharge from the hospital, up to 30 days of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Yehia El-Sayed
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17601897
Citation
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.
Results Reference
result
PubMed Identifier
35947046
Citation
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.
Results Reference
derived
Links:
URL
http://www.greenjournal.org/
Description
Obstet Gynecol. 2007 Jul;110(1):61-7.

Learn more about this trial

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

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