Labor, Obstetric
Conditions
Keywords
Primary slow progress, Prolonged latent phase, Labor arrest
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.
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
Interventions
DRUGDF 01
DRUGOxytocin
DRUGPlacebo
Sponsors
Dilafor AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from start of infusion of tafoxiparin/placebo until vaginal partus | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Proportion of women undergoing instrumental deliveries | From start of study drug administration to instrumental delivery (hours, up to 36 hours) | — |
| Use of analgesia (N2O, epidural, pudendal nerve block) | From start of study drug administration to any delivery (hours, up to 36 hours) | — |
| Safety will be evaluated through rate and frequency of adverse events and serious adverse events | 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 |
| 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) | — |
| Uterine hyperstimulation with fetal heart rate changes | From start of study drug administration to any delivery (hours, up to 36 hours) | — |
| Indication for referral to NICU | From start of study drug administration through study completion (6 months +- 4 weeks after delivery) | — |
| Use of Oxytocin (no. of mls. according to instructions) | From start of study drug administration to any delivery (hours, up to 36 hours) | — |
| Pharmacokinetic response | From start of study drug administration to any delivery (hours, up to 36 hours) | Measurement of study drug in plasma at one time point |
| 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) | — |
Countries
Denmark, Finland, Sweden
Outcome results
None listed