CompletedPhase 4

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

Israel129 participantsStarted 2018-12-19

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 18 years of age
✓. Tocolytic treatment between 24+0 and 34+0 weeks
✓. Patient's consent to participate in this study
✓. 24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment
✓. Arrest of preterm labor

Exclusion criteria

✕. Contraindication to ongoing pregnancy including:
✕. Suspected amnionitis during testing for eligibility- evidence of active infection including temperature ≥ 38.0°C and uterine tenderness, foul-smelling vaginal discharge, maternal tachycardia of 120 beats per minute or greater, or sustained fetal tachycardia of 160 beats per minute or greater
✕. Evidence of significant placental abruption (contractions and significant bleeding from placental origin)
✕. Intrauterine fetal death diagnosed at the time of admission
✕. Major fetal malformation
✕. Known maternal allergy to progesterone
✕. Current use of progesterone at the time of admission
✕. Epilepsy

What they're measuring

The mean number of days from enrollment to delivery

Timeframe: Up to 18 weeks

The rate of preterm spontaneous delivery

Timeframe: Up to 13 weeks

Trial details

NCT IDNCT02430233

SponsorHaEmek Medical Center, Israel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-27

View on ClinicalTrials.gov More Preterm Labor trials