Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-26 @ 12:00 PM
Study NCT ID:
NCT02430233
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2015-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor
Sponsor:
HaEmek Medical Center, Israel
Organization:
Study Overview
Official Title:
Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor - Randomized Double Blind Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.
Detailed Description:
Since progesterone derivatives are useful in preventing preterm labor in cases of risk factors or previous preterm labor, we hypothesize that they will also show efficacy in pregnancy prolongation in women whose preterm labor was arrested following tocolytic treatment.
Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.
This study has the potential to find a treatment to prevent preterm labor and thus to reduce neonatal morbidity and mortality.
Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.
This study has the potential to find a treatment to prevent preterm labor and thus to reduce neonatal morbidity and mortality.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: