Effect of Tafoxiparin on Cervical Ripening and Induction... | NCT04000438

NCT04000438

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2019-000620-17	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental DF01 high dose	Experimental	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.	Drug: DF01
Experimental: DF01 medium dose	Experimental	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.	Drug: DF01
Experimental: DF01 low dose	Experimental	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.	Drug: DF01
Placebo comparator: PL1	Placebo Comparator	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.	Drug: PL1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DF01	Drug	DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cervical Ripening Rate, Measured by Bishop Score - Slope	Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope. Bishop score is an Assessment of the cervical stage by its: dilatation, position, effacement and consistency. The score was calculated as the sum of the following 5 categories where each category is scored between 0-2: Fetal station (0-2) Cervical diameter at inner meatus (0-2) Cervical effacement (0-2) Consistency at inner meatus (0-2) Cervical position (0-2) Graded from 0-10, Bishop score of ≤ 4 is unripe and ≥ 6 is ripe. Bishop score was measured daily from start of treatment up until 7 days. The cervical ripening rate was calculated from the slope of the curve (score/day) when plotting Bishop score against days of treatment.	Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).

Eligibility Module

Eligibility Criteria

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
Presence of eclampsia
Severe Pre-eclampsia
HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets)
Clinically significant vaginal bleeding in need of hospitalization in the third trimester
Placenta previa
Previously known coagulation disorders (Leiden, heterozygote - OK)
Current use of any drugs that interfere with hemostasis (including heparin /LMWH, direct oral anti-coagulant medication, non-steroidal anti-inflammatory drugs (NSAID) compounds and vitamin K antagonists.)
Current use of acetylsalicylic acid (ASA) compounds or use within the week preceding inclusion
Diagnosed with HIV or Acute hepatitis
Known history of allergy to standard heparin and/or LMWH heparin
History of heparin-induced thrombocytopenia
Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study.
Current participation in other interventional medicinal treatment studies
Subject has a fear of needles which is believed by the Investigator to affect study medication compliance

Name	Affiliation	Role
Gunvor Ekman-Ordeberg, MD, PhD, Study Chair, CMO	CMO	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Naistenklinikka (HUS)		Helsinki		00029	Finland
Tampere University Hospital

Arm/Group Information

ID	Title	Description
FG000	Experimental DF01 High Dose	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
FG001	Experimental: DF01 Medium Dose	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
FG002	Experimental: DF01 Low Dose	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
FG003	Placebo Comparator: PL1	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. PL1: The subject receives sc injections of placebo solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Experimental DF01 High Dose	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Cervical Ripening Rate, Measured by Bishop Score - Slope

Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope.

Bishop score is an Assessment of the cervical stage by its: dilatation, position, effacement and consistency.

The score was calculated as the sum of the following 5 categories where each category is scored between 0-2:

Fetal station (0-2)
Cervical diameter at inner meatus (0-2)
Cervical effacement (0-2)
Consistency at inner meatus (0-2)
Cervical position (0-2) Graded from 0-10, Bishop score of ≤ 4 is unripe and ≥ 6 is ripe.

Bishop score was measured daily from start of treatment up until 7 days. The cervical ripening rate was calculated from the slope of the curve (score/day) when plotting Bishop score against days of treatment.

Posted

Mean

Standard Deviation

Slope (Bishop Score/day)

Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).

ID	Title	Description
OG000	Experimental DF01 High Dose

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Experimental DF01 High Dose	The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.