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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Effect of Continuous Infusion of Tafoxiparin as an Adjunct Treatment to Oxytocin for up to 36 Hours in Term Pregnant, Nulliparous Women to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest
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.
Primary objective To assess the dose-response relationship of tafoxiparin on the labor time defined as the time from the start of continuous infusion of tafoxiparin/placebo as an Adjunct Treatment to Oxytocin, until partus in term-pregnant, nulliparous women requiring labor augmentation due to Primary Slow Progress of Labor including prolonged latent phase and Labor Arrest. Secondary objectives To assess the safety and efficacy of tafoxiparin based on the safety and secondary efficacy parameters evaluated in the protocol. PK (pharmacokinetic) response in pregnant women during labor. Methodology All term-pregnant, nulliparous women presenting to the delivery ward are potential study patients unless they have already been enrolled in another clinical study. Subjects may be pre-informed about the study through the use of advertisements or information at the physician/midwife visits during pregnancy and at hospital admission. The whole study includes the following steps: * Screening and Baseline including informed consent and randomization * Labor * Discharge * Follow-up at 8 (+/-1)weeks - End of study * Safety follow up of infant at 6 months, +/-4 weeks, by telephone interview
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
Yes
Hvidovre Hospital, Fødeafdelingen
Hvidovre, Denmark
Naistenklinikka (HUS) Naistentaudit ja synnytykset
Helsinki, Finland
Kätilöopiston Sairaala (HUS)
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Helsingborg Förlossningen, Helsingborgs Lasarett
Helsingborg, Sweden
Länssjukhuset Ryhov
Jönköping, Sweden
Karlstad Kvinnokliniken Centralsjukhuset
Karlstad, Sweden
Kvinnokliniken Universitesjukhuset
Linköping, Sweden
Kvinnokliniken Vrinnevisjukhuset
Norrköping, Sweden
Skaraborgs sjukhus
Skövde, Sweden
Start Date
December 1, 2016
Primary Completion Date
November 1, 2018
Completion Date
May 1, 2019
Last Updated
April 29, 2020
361
ACTUAL participants
DF 01
DRUG
Oxytocin
DRUG
Placebo
DRUG
Lead Sponsor
Dilafor AB
NCT07430358
NCT06980220
Data Source & Attribution
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