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

Labor, Obstetric Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001193
• Other study ID #: PPL07
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: May 2019

Study information

• Verified date: April 2020
• Source: Dilafor AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: May 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor, Obstetric

Intervention

Drug:
• DF 01

• Oxytocin

• Placebo

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital, Fødeafdelingen	Hvidovre
Finland	Kätilöopiston Sairaala (HUS)	Helsinki
Finland	Naistenklinikka (HUS) Naistentaudit ja synnytykset	Helsinki
Finland	Tampere University Hospital	Tampere
Sweden	Helsingborg Förlossningen, Helsingborgs Lasarett	Helsingborg
Sweden	Länssjukhuset Ryhov	Jonkoping
Sweden	Karlstad Kvinnokliniken Centralsjukhuset	Karlstad
Sweden	Kvinnokliniken Universitesjukhuset	Linkoping
Sweden	Kvinnokliniken Vrinnevisjukhuset	Norrkoping
Sweden	Skaraborgs sjukhus	Skovde
Sweden	Norra Älvsborgs Länssjukhus	Trollhattan
Sweden	Akademiska sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Dilafor AB

Countries where clinical trial is conducted

Denmark,  Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety will be evaluated through rate and frequency of adverse events and serious adverse events	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	Through study completion ( 6 months, +/-4 weeks after delivery)
Secondary	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 )
Secondary	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 )
Secondary	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 )
Secondary	Proportion of women with caesarean sections		From start of study drug administration to caesarean section (hours, up to 36 hours)
Secondary	Proportion of women undergoing instrumental deliveries		From start of study drug administration to instrumental delivery (hours, up to 36 hours)
Secondary	Use of analgesia (N2O, epidural, pudendal nerve block)		From start of study drug administration to any delivery (hours, up to 36 hours)
Secondary	Proportion of women with postpartum hemorrhage > 1000 ml		From start of study drug administration and up to 7 days or discharge whichever comes first (days)
Secondary	Fetal outcome measured as Apgar score (5 min) = 7 points, Base Excess > -12 and referral to NICU (neonatal intensive care unit) (for > 48 hours		From start of study drug administration and up to 7 days or discharge whichever comes first (days)
Secondary	Uterine hyperstimulation with fetal heart rate changes		From start of study drug administration to any delivery (hours, up to 36 hours)
Secondary	Indication for referral to NICU		From start of study drug administration through study completion (6 months +- 4 weeks after delivery)
Secondary	Use of Oxytocin (no. of mls. according to instructions)		From start of study drug administration to any delivery (hours, up to 36 hours)
Secondary	Pharmacokinetic response	Measurement of study drug in plasma at one time point	From start of study drug administration to any delivery (hours, up to 36 hours)