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

Dilafor AB361 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

361

Conditions

Labor, Obstetric

Interventions

DF 01DRUG

OxytocinDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Pregnant women of ≥18 to ≤45 years of age 2. Nulliparous 3. Gestational age \> 36 weeks + 6 days confirmed by ultrasound 4. Experience slow progress of labor including prolonged latent phase and labor arrest (according to the respective definitions) etc Exclusion Criteria: 1. Subjects with secondary slow progress or secondary labor arrest 2. BMI≥35 during first trimester of pregnancy 3. Breech presentation or other abnormal presentations etc

Locations (12)

Hvidovre Hospital, Fødeafdelingen

Hvidovre, Denmark

Naistenklinikka (HUS) Naistentaudit ja synnytykset

Helsinki, Finland

Kätilöopiston Sairaala (HUS)

Helsinki, Finland

Outcomes

Primary Outcomes

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

The primary endpoint (time from first infusion to vaginal partus) will be summarized graphically for each treatment group using Kaplan-Meier estimates. In addition to this statistical comparison between the treatments will be performed using the analysis of variance technique.

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

Secondary Outcomes

Safety will be evaluated through rate and frequency of adverse events and serious adverse events

Safety will be evaluated through rate and frequency of adverse events and serious adverse events, complete and symptom-directed physical evaluations, vital signs, safety blood samples (hematology and clinical chemistry), and rate of withdrawals from the study and/or the study medication

Time frame: Through study completion ( 6 months, +/-4 weeks after delivery)

Time from cervical dilatation of 4 cm and progress of labor until vaginal partus

Time frame: Interval from 4 cm of cervical dilatation to vaginal delivery (hours, up to 36 hours )

Proportion of women with dystocia/protracted labor defined as ≥8, 10, 12 and 14 hours of established labor (4 cm of cervical dilation to vaginal partus )

Time frame: Interval from 4 cm of cervical dilatation to vaginal delivery (hours, up to 36 hours )

Proportion of women with dystocia/protracted labor defined as ≥8, 10, 12 and 14 hours from start of study drug infusion to vaginal partus

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

Proportion of women with caesarean sections

Time frame: From start of study drug administration to caesarean section (hours, up to 36 hours)

Data from ClinicalTrials.gov

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