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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03001193
Other study ID # PPL07
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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