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Trial record 1 of 1 for:    PPL07
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Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest

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ClinicalTrials.gov Identifier: NCT03001193
Recruitment Status : Active, not recruiting
First Posted : December 22, 2016
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dilafor AB

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.

Condition or disease Intervention/treatment Phase
Labor, Obstetric Drug: DF 01 Drug: Oxytocin Drug: Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: 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
Drug: DF 01
Other Name: Tafoxiparin

Drug: Oxytocin
Experimental: 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
Drug: DF 01
Other Name: Tafoxiparin

Drug: Oxytocin
Experimental: 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
Drug: DF 01
Other Name: Tafoxiparin

Drug: Oxytocin
Placebo Comparator: 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
Drug: Oxytocin
Drug: Placebo
Other Name: PL1




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001193


Locations
Denmark
Hvidovre Hospital, Fødeafdelingen
Hvidovre, Denmark, 2650
Finland
Naistenklinikka (HUS) Naistentaudit ja synnytykset
Helsinki, Finland, 00029
Kätilöopiston Sairaala (HUS)
Helsinki, Finland, 00610
Tampere University Hospital
Tampere, Finland, 33521
Turun Yliopistollinen Sairaala
Turku, Finland, Turku
Sweden
Helsingborg Förlossningen, Helsingborgs Lasarett
Helsingborg, Sweden, 25187
Länssjukhuset Ryhov
Jonkoping, Sweden, 55305
Karlstad Kvinnokliniken Centralsjukhuset
Karlstad, Sweden, 65230
Kvinnokliniken Universitesjukhuset
Linkoping, Sweden, 58185
Kvinnokliniken Vrinnevisjukhuset
Norrkoping, Sweden, 60182
Skaraborgs sjukhus
Skovde, Sweden, 54185
Norra Älvsborgs Länssjukhus
Trollhattan, Sweden, 46173
Akademiska sjukhuset
Uppsala, Sweden, 75185
Västerås Förlossningsavdelning Västmanlands Sjukhus
Västerås, Sweden, 72189
Sponsors and Collaborators
Dilafor AB
Investigators
Study Chair: Gunvor Ekman-Ordeberg, MD, PhD Dilafor AB

Responsible Party: Dilafor AB
ClinicalTrials.gov Identifier: NCT03001193     History of Changes
Other Study ID Numbers: PPL07
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dilafor AB:
Primary slow progress
Prolonged latent phase
Labor arrest

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs