NCT02430233

Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor

Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor - Randomized Double Blind Placebo Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Labor

Interventions

Type	Name	Description
DRUG	micronized progesterone 400 mg (Utrogestan)	participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)

Timeline

• Start date: 2018-12-19
• Primary completion: 2023-02-27
• Completion: 2023-02-27
• First posted: 2015-04-30
• Last updated: 2023-02-28

Locations

3 sites across 1 country: Israel