Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an … (NCT04000438) | Clinical Trial Compass
CompletedPhase 2
Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix
Finland, Sweden365 participantsStarted 2019-06-21
Plain-language summary
The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe cervix undergoing Labor Induction. If the efficacy and safety profiles of Section A are conclusive in favor of tafoxiparin, the study will continue by adding two additional tafoxiparin dose groups in Section B.
Who can participate
Age range18 Years – 64 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant women of ≥18 and ≤ 64 years of age
* Nulliparous
* Unripe cervix with ≤ 4points according to Bishop/Westin score (0-10 points scale)
* Planned for labor induction after 4-7 days of IMP treatment
* Examples of diagnosis as a basis for induction:
* Post term pregnancy (40-41 weeks of gestation)
* Gestational diabetes
* Diabetes type 1 - well controlled
* Pre-eclampsia (BP diastolic \<100, systolic \<140)
* Hypertension - well controlled
* Hepatosis (without clinically significantly elevated serum bile acids)
* Maternal age ≥ 40 years
* Humanitarian-psycho social reasons
* Oligohydramnios
* Gestational age \> 37 weeks confirmed by ultrasound before 21 weeks of gestation
* Singleton pregnancy
* Subject is, as per the discretion of the Investigator, able to comply with the requirements of the protocol including an ability to be present at all required controls
* Subject can understand and sign an informed form
* Provision of written informed consent
Exclusion Criteria:
* Subjects who are unable to understand the written and verbal instructions in local language
* Breech presentation and other abnormal fetal presentations
* Previous uterine scar
* Spontaneous rupture of membranes at inclusion
* Pathologic CTG at inclusion
* Fetal estimated weight \> 2SD of normal fetal estimated weight earlier diagnosed by ultrasound and documented in patient record
* Mother's BMI \> 35 at early pregnancy
* Known IUGR defined as ≤ 2SD of normal
*…
What they're measuring
1
Cervical Ripening Rate, Measured by Bishop Score - Slope
Timeframe: Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).