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

Dilafor

Status and phase: Completed; Phase 2

Conditions: Labor, Obstetric

Treatments: Drug: Oxytocin; Drug: Placebo; Drug: DF 01

Study type: Interventional

Funder types: Industry

Identifiers

NCT03001193

PPL07

Details and patient eligibility

About

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.

Full description

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

Enrollment: 361 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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361 participants in 4 patient groups, including a placebo group

DF01 low dose

Experimental group

Description:

The subjects will receive intravenous infusion of DF01 (tafoxiparin) in low dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery

Treatment:

Drug: DF 01

Drug: Oxytocin

DF01 medium dose

Experimental group

Description:

The subjects will receive intravenous infusion of DF01 (tafoxiparin) in medium dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery

Treatment:

Drug: DF 01

Drug: Oxytocin

DF01 high dose

Experimental group

Description:

The subjects will receive intravenous infusion of DF01 (tafoxiparin) in high dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery

Treatment:

Drug: DF 01

Drug: Oxytocin

PL1

Placebo Comparator group

Description:

The subjects will receive intravenous infusion of placebo as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery

Treatment:

Drug: Placebo

Drug: Oxytocin