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 range
18 Years – 64 Years
Sex
FEMALE
See this in plain English?
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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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).