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

NCT ID: NCT03001193

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 361 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-05-31

Brief 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.

Detailed 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

Conditions

Labor, Obstetric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DF01 low dose

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

Group Type: EXPERIMENTAL

DF 01

Intervention Type: DRUG

Oxytocin

Intervention Type: DRUG

DF01 medium dose

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

Group Type: EXPERIMENTAL

DF 01

Intervention Type: DRUG

Oxytocin

Intervention Type: DRUG

DF01 high dose

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

Group Type: EXPERIMENTAL

DF 01

Intervention Type: DRUG

Oxytocin

Intervention Type: DRUG

PL1

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

Group Type: PLACEBO_COMPARATOR

Oxytocin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

DF 01

Intervention Type: DRUG

Oxytocin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Tafoxiparin; PL1

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dilafor AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunvor Ekman-Ordeberg, MD, PhD

Role: STUDY_CHAIR

Dilafor AB

Locations

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

Norra Älvsborgs Länssjukhus

Trollhättan, , Sweden

Akademiska sjukhuset

Uppsala, , Sweden

Countries

Denmark; Finland; Sweden

References

Ekman-Ordeberg G, Hellgren-Wangdahl M, Jeppson A, Rahkonen L, Blomberg M, Pettersson K, Bejlum C, Engberg M, Ludvigsen M, Uotila J, Tihtonen K, Hallberg G, Jonsson M. Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from 2 randomized, placebo-controlled studies. Am J Obstet Gynecol. 2024 Mar;230(3S):S759-S768. doi: 10.1016/j.ajog.2022.10.013. Epub 2023 May 17.

Reference Type: DERIVED

PMID: 38462256 (View on PubMed)

Other Identifiers

PPL07

Identifier Type: -

Identifier Source: org_study_id