CompletedPhase 2

Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest

Denmark, Finland, Sweden361 participantsStarted 2016-12

Plain-language summary

The study will be designed as a double-blind, placebo-controlled, parallel-group, dose-finding study with one group treated with placebo and three groups treated with tafoxiparin in three different infusion concentration levels, respectively. The intravenous infusion will be initiated by a pre-defined bolus dose infusion.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion criteria

✓. Pregnant women of ≥18 to ≤45 years of age
✓. Nulliparous
✓. Gestational age \> 36 weeks + 6 days confirmed by ultrasound
✓. Experience slow progress of labor including prolonged latent phase and labor arrest (according to the respective definitions) etc

Exclusion criteria

✕. Subjects with secondary slow progress or secondary labor arrest
✕. BMI≥35 during first trimester of pregnancy
✕. Breech presentation or other abnormal presentations etc

What they're measuring

Time from start of infusion of tafoxiparin/placebo until vaginal partus

Timeframe: Interval from start of study drug administration to vaginal delivery (hours, up to 36 hours )

Trial details

NCT IDNCT03001193

SponsorDilafor AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11

View on ClinicalTrials.gov More Labor, Obstetric trials