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Corticosteroid

Betamethasone for PPROM

Phase 2 & 3

Waitlist Available

Led By Benjamin Bush, MD

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily from birth of infant up to one year

Awards & highlights

Study Summary

This trial will test if a repeat course of the drug betamethasone given to pregnant women with PPROM will decrease the length of stay in the NICU for their infants, as well as the infant's overall morbidity.

Eligible Conditions

Premature Rupture of Membranes
Respiratory Distress Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from admission to delivery up to one year, or through study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from admission to delivery up to one year, or through study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from admission to delivery up to one year, or through study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of stay in the neonatal intensive care unit (NICU)

Secondary outcome measures

Composite neonatal morbidity

Development of Respiratory Distress Syndrome (RDS)

Duration of oxygen and ventilatory support

+4 more

Other outcome measures

Infectious morbidities

Labor latency

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BetamethasoneExperimental Treatment1 Intervention

Women admitted with PPROM who will receive a second course of two betamethasone 12mg intramuscular (IM) injections given 24 hours apart.

Group II: Saline PlaceboPlacebo Group1 Intervention

Women admitted with PPROM who will receive intramuscular saline placebo, given as two injections 24 hours apart.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Betamethasone

2010

Completed Phase 4

~5440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor

241 Previous Clinical Trials

56,565 Total Patients Enrolled

Benjamin Bush, MDPrincipal InvestigatorUniversity of Texas Medical Branch in Galveston

Antonio Saad, MDPrincipal InvestigatorUniversity of Texas Medical Branch in Galveston

7 Previous Clinical Trials

2,129 Total Patients Enrolled

Media Library

Betamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02939742 — Phase 2 & 3

Respiratory Distress Syndrome Research Study Groups: Betamethasone, Saline Placebo

Respiratory Distress Syndrome Clinical Trial 2023: Betamethasone Highlights & Side Effects. Trial Name: NCT02939742 — Phase 2 & 3

Betamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02939742 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve adults over the age of 30?

"Eligibility requirements for this clinical trial include being between the ages of 18-50."

Answered by AI

Are there still open slots for volunteers in this research?

"The latest information from clinicaltrials.gov suggests that this trial is still recruiting patients. The initial posting for the trial was on November 1st, 2016 with the most recent update being February 7th, 2022."

Answered by AI

For what reason is Betamethasone typically prescribed?

"Betamethasone is most often used to ameliorate nephrotic syndrome. However, it has also shown efficacy in treating conditions such as brain cancer, ophthalmia, and sympathetic eye disorders."

Answered by AI

Who would be most beneficial to include in this clinical trial?

"This research is looking for 98 individuals that were born prematurely, are between 18-50 years old, and meet the following qualifications: Cervical dilation must be 5 centimeters or less when examined with a sterile speculum and there should be no indication that delivery will happen in the next 7 days."

Answered by AI

Recent research and studies

Obstetrics & GynecologyJournal

Effectiveness of Antenatal Steroids in Obstetric Subgroups

Elimian, A. 1999. “Effectiveness of Antenatal Steroids in Obstetric Subgroups”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0029-7844(98)00400-1.

Obstetrics & GynecologyJournal

Effectiveness of Multidose Antenatal Steroids

Elimian, A. 2000. “Effectiveness of Multidose Antenatal Steroids”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0029-7844(99)00471-8.

Obstetrics & GynecologyJournal

Practice Bulletin No. 139

“Practice Bulletin No. 139”. 2013. “Practice Bulletin No. 139”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.aog.0000435415.21944.8f.

American Journal of PerinatologyJournal