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

NCT03001193 | Completed Phase 2

• 1 other identifier: PPL07
• Study Type: interventional
• Target: 361
• Locations: 3 countries
• Sites: 12

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.

Conditions

Labor, Obstetric

Keywords

Primary slow progress; Prolonged latent phase; Labor arrest

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (13)

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

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

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

  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 )

  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

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

• Proportion of women with caesarean sections

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

Study Arms (4)

DF01 low dose

EXPERIMENTAL

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

Drug: DF 01; Drug: Oxytocin

DF01 medium dose

EXPERIMENTAL

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

Drug: DF 01; Drug: Oxytocin

DF01 high dose

EXPERIMENTAL

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

Drug: DF 01; Drug: Oxytocin

PL1

PLACEBO COMPARATOR

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

Drug: Oxytocin; Drug: Placebo

Interventions

DF 01 DRUG

Also known as: Tafoxiparin

DF01 high dose; DF01 low dose; DF01 medium dose

Oxytocin DRUG

DF01 high dose; DF01 low dose; DF01 medium dose; PL1

Placebo DRUG

Also known as: PL1

PL1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dilafor AB: lead

Study Sites (12)

Hvidovre Hospital, Fødeafdelingen

Hvidovre, 2650, Denmark

Location

Naistenklinikka (HUS) Naistentaudit ja synnytykset

Helsinki, 00029, Finland

Location

Kätilöopiston Sairaala (HUS)

Helsinki, 00610, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Helsingborg Förlossningen, Helsingborgs Lasarett

Helsingborg, 25187, Sweden

Location

Länssjukhuset Ryhov

Jönköping, 55305, Sweden

Location

Karlstad Kvinnokliniken Centralsjukhuset

Karlstad, 65230, Sweden

Location

Kvinnokliniken Universitesjukhuset

Linköping, 58185, Sweden

Location

Kvinnokliniken Vrinnevisjukhuset

Norrköping, 60182, Sweden

Location

Skaraborgs sjukhus

Skövde, 54185, Sweden

Location

Norra Älvsborgs Länssjukhus

Trollhättan, 46173, Sweden

Location

Akademiska sjukhuset

Uppsala, 75185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38462256 DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Gunvor Ekman-Ordeberg, MD, PhD

  Dilafor AB

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 22, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: May 1, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (8); DK (1); FI (3)