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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

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

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

NCT ID

NCT00185900

First Posted

September 12, 2005

Last Updated

October 2, 2018

Sponsor

Stanford University

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

Eligibility Criteria

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

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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