NCT00463736

Brief Summary

Study compares the outcomes of women between 26 and 32 wks gestation with rupture of membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

April 19, 2007

Last Update Submit

August 17, 2016

Conditions

Preterm Premature Rupture of Membranes

Keywords

short term tocolysispreterm premature rupture of membranes

Outcome Measures

Primary Outcomes (1)

  • hours of latency to delivery

    from start of study drug to delivery

    0 hours to > 168 hours

Secondary Outcomes (5)

  • maternal postpartum length of stay

    0 hours to > 168 hours

  • maternal infection rates

    0 hours to > 168 hours

  • neonatal ventilator days

    0 to 28 days

  • neonatal early onset infection

    0 to 28 days

  • neonatal length of stay

    0 to 28 days

Study Arms (2)

Magnesium sulfate

ACTIVE COMPARATOR

x 48 hours IV

Drug: Magnesium sulfate

Normal saline

PLACEBO COMPARATOR

x 48 hours IV

Drug: Magnesium sulfate

Interventions

Magnesium sulfateDRUG
Magnesium sulfateNormal saline

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English or Spanish speaking
  • preterm premature rupture of membranes
  • weeks gestation
  • cervical dilation \</= 4 cm

You may not qualify if:

  • suspected intrauterine or intraamniotic infection
  • \> 6 hours of tocolysis prior to admission
  • positive fetal lung maturity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Obstetrical Consultants

Chattanooga, Tennessee, 37403, United States

Location

Related Publications (1)

  • 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.

    PMID: 35947046DERIVED

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Christian M Briery, MD

    Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Christian Briery MD

Study Record Dates

First Submitted

April 19, 2007

First Posted

April 20, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

US(1)