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NCT Number: NCT03001193

Effect of Tafoxiparin 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.

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Key information

Conditions

Labor, Obstetric

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hvidovre Hospital, Fødeafdelingen, Hvidovre, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

DF 01

Drug

Other names: Tafoxiparin

Oxytocin

Drug

Placebo

Drug

Other names: PL1

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    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

  2. 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 )

  3. 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 )

  4. 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 )

  5. Proportion of women with caesarean sections

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

  6. Proportion of women undergoing instrumental deliveries

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

  7. Use of analgesia (N2O, epidural, pudendal nerve block)

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

  8. Proportion of women with postpartum hemorrhage > 1000 ml

    Time frame: From start of study drug administration and up to 7 days or discharge whichever comes first (days)

  9. Fetal outcome measured as Apgar score (5 min) ≤ 7 points, Base Excess > -12 and referral to NICU (neonatal intensive care unit) (for > 48 hours

    Time frame: From start of study drug administration and up to 7 days or discharge whichever comes first (days)

  10. Uterine hyperstimulation with fetal heart rate changes

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

  11. Indication for referral to NICU

    Time frame: From start of study drug administration through study completion (6 months +- 4 weeks after delivery)

  12. Use of Oxytocin (no. of mls. according to instructions)

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

  13. Pharmacokinetic response

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

    Measurement of study drug in plasma at one time point

Sponsors and collaborators

Lead sponsor

Dilafor AB

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 22, 2016
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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