NCT03133104

Brief Summary

This study will review records of women who broke their water early who received a repeat course of antenatal steroids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 5, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

January 17, 2017

Last Update Submit

November 27, 2017

Conditions

Antenatal Corticosteroids

Outcome Measures

Primary Outcomes (1)

  • Infant outcomes

    infant birth weight

    1 year

Study Arms (2)

antenatal corticosteroids

Women who received a rescue dose of steroids

Other: Antenatal corticosteroids

No antenatal corticosteroids

Women who did not received a rescue dose of steroids

Interventions

Antenatal corticosteroidsOTHER

Women and neonates with PPROM who received a repeat dose of antenatal corticosteroids, compared to women with PPROM who did not received a repeat course of antenatal corticosteriods

antenatal corticosteroids

Eligibility Criteria

Age13 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women preterm premature rupture of membranes All ethnic backgrounds

You may qualify if:

  • pregnant women with preterm premature rupture of membranes

You may not qualify if:

  • Women who did not have preterm premature rupture of membranes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

Study Officials

  • Cara Buskmiller, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2017

First Posted

April 28, 2017

Study Start

January 5, 2017

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)