Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04000438

Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix

Labor Onset and Length Abnormalities Clinical Trial

Official title:
Randomized, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy on Cervical Ripening, Safety, Tolerability and Dose Response of SC Administered Tafoxiparin in Term Pregnant, Nulliparous Women With an Unripe Cervix Undergoing Labor Induction

Clinical Trial 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.

Clinical Trial Description

Primary objective: To assess the efficacy of tafoxiparin on cervical ripening. Secondary objective: To assess the maternal and neonatal safety, tolerability and dose response of tafoxiparin as a supplement therapy in term pregnant, nulliparous women with an unripe cervix undergoing labor induction Methodology: Term pregnant, nulliparous women with unripe cervix and planned for labor induction are potential study patients unless enrolled in another study. Subjects may be preinformed about the stuyd through the use of advertisement or information at the physician/midwife visits during pregnancy and at the hospital admission. The whole study includes the following steps: Screening and Baseline including informed consent and randomization Study treatment and Induction of Labor Labor Discharge ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04000438
Study type Interventional
Source Dilafor AB
Contact
Status Completed
Phase Phase 2
Start date June 21, 2019
Completion date March 30, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT06343480 - Misoprostol Versus Oxytocin for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term N/A
Not yet recruiting NCT03985618 - The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity N/A
Not yet recruiting NCT05510310 - Breast Stimulation vs. Low Dose Oxytocin Augmentation for Labor Induction Phase 1/Phase 2
Completed NCT06151925 - Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening N/A
Completed NCT05084326 - Engagement of Fetal Head as a Predictor of a Successful Vaginal Delivery in Primigravidas Presented in Early Labor.
Completed NCT03670836 - Comparison of Misoprostol Ripening Efficacy With Dilapan Phase 4
Terminated NCT04564196 - Breath Metabolomics in the Laboring Parturient
Withdrawn NCT05255263 - Goal-directed Labor Epidural Analgesia Maintenance N/A
Completed NCT05262738 - Misoprostol Dosing in BMI Greater Than 30 Phase 4
Recruiting NCT05489315 - Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor N/A
Not yet recruiting NCT05791630 - The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL) N/A
Completed NCT04933708 - LaPPS: Labor Podcast for Patient Satisfaction N/A
Not yet recruiting NCT03784092 - Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial N/A
Recruiting NCT04271722 - Clinical Evaluation of Cervical Ripening in the Outpatient Setting N/A
Recruiting NCT06164613 - Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial Phase 2
Terminated NCT04504682 - Ambulation With Labor Epidural in Obese Women N/A