Conditions: Labor Onset and Length Abnormalities
Keywords: Priming of labor Unripe cervix Home treatment Cervical ripening Labor induction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 365
Healthy volunteers: yes

Brief 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.

Detailed 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 study 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

Arms:
arm 1: The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. arm 2: The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. arm 3: The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. arm 4: The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.

Interventions: intervention 1: DF01 intervention 2: PL1
Intervention descriptions: intervention 1: 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 intervention 2: DF01: 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

Protocol document:
Prot_SAP_000.pdf: 
Conﬁdenal/Clinical Study Protocol PPL17 – Dilafor 
Version 1.7 Final/ January/15th 2022_Sweden/Finland 
 
1 
PROTOCOL SYNOPSIS PPL17 
 
Working title 
A Randomized, Double-Blind, Placebo-Controlled, Parallel-
Group Proof of Concept Study (Part A (Section A)) with a 
conditional dose finding follow up (Part A (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.  
Sponsor Protocol No. PPL17 
Eudract number: 2019-000620-17 
Coordinating Investigator:  
Dr Maria Jonsson 
Förlossningsavdelningen 
Akademiska sjukhuset  
751 85 Uppsala  
 
National coordinator - Finland: 
Dr Leena Rahkonen 
Naistenklinikka  (HUS)  
Naistentaudit ja synnytykset  
PL 140 00029 Helsinki 
 
Trial period 
First subject to be enrolled in Q-2 2019 
Last subject’s last visit Q-2 2021 (POC) 
Last subject’s last visit Q-2 2022 (Dose-finding) 
Phase of development - II 
 
Objectives 
Primary: To assess the Efficacy of tafoxiparin on cervical 
ripening.  
Secondary: 
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  
Study design 
A randomized, double-blind, placebo-controlled, parallel-group, 
multi-center Proof of Concept study (Part A) with a conditional 
dose-finding add-on (Part B).  
 
Part B will be added conditional to both statistically significant 
difference between the treatment groups and a satisfactory safety 
profile of tafoxiparin in Part A. 
See also Flow Charts in appendix 14.1 of the protocol 


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2 
Endpoints  
 Efficacy  
Primary Efficacy endpoint: 
Cervical ripening rate during up to the first seven days of 
treatment, measured by Bishop score 
 
Secondary Efficacy endpoints include: 
i) 
Time from start of treatment to increase in Bishop score 
of ≥ 2 points or spontaneous onset of labor, whichever 
comes first 
ii) 
Time from start of treatment to increase in Bishop score 
of ≥ 3 points or spontaneous onset of labor, whichever 
comes first 
iii) 
Time from start of treatment to increase in Bishop score 
of ≥ 4 points or spontaneous onset of labor, whichever 
comes first 
iv) 
Cervical ripening as measured by change from baseline 
to end of treatment in Bishop Score 
v) 
Time from onset of labor to partus. Onset of labor is 
defined as last record of 4 cm cervical dilatation 
visualized in the partogram and progress of labor or last 
record of 4 cm of cervical dilatation in combination 
with amniotomy and intravenous administration 
oxytocin 
vi) 
Proportion 
of 
women 
with 
established 
labor 
≤ 6 hours  
vii) 
Proportion of women with labor time ≤ 8 hours 
viii) 
Proportion 
of 
women 
with 
established 
labor 
≥ 12 hours 
ix) 
Total dosages of study drug (IMP) 
x) 
Proportion of women with spontaneous labor (response 
group I)  
xi) 
Proportion of women with a ripe cervix (response group 
I+II)  
xii) 
Proportion of women in response groups (I-IV)
 
Safety and 
tolerability 
Secondary Safety and tolerability endpoints include: 
Safety and tolerability 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 and by 
the following safety variables: 


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3 
i) 
Proportion of patients undergoing caesarean sections 
(CS) 
ii) 
Indications for CS  
iii) 
Proportion of patients undergoing instrumental 
deliveries (vacuum extraction (VE)/forceps delivery) 
iv) 
Indications for VE and forceps deliveries 
v) 
Fetal outcome measured as Birth weight, Apgar score, 
Acidosis (pH<7.10) and/or Base Excess < -12 mmol/L 
arterial or venous in umbilical cord blood  
vi) 
Indication for referral to neonatal intensive care unit 
(NICU) 
vii) 
Proportion of infants staying in the NICU for > 48 
hours. 
viii) 
Uterine hyper stimulation in demand of tocolytic 
treatment  
ix) 
Proportion of patients with Postpartum Hemorrhage 
(PPH) > 2000 ml 
 
Selection 
criteria  
Inclusion 
In order to participate in this study, the subjects must meet all of 
the following inclusion criteria: 
i) 
Pregnant women of ≥18 and ≤ 64 years of age 
ii) 
Nulliparous  
iii) 
Unripe 
cervix 
with 
≤ 
4points 
according 
to 
Bishop/Westin score (0-10 points scale) 
iv) 
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 
v) 
Gestational age > 37 weeks confirmed by ultrasound 
before 21 weeks of gestation  
vi)    Singleton pregnancy 
vii)   Subject is, as per the discretion of the Investigator,
    able 
to 
comply 
with 
the


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4 
   requirements of the protocol including an ability to
   be present at all required controls 
viii) Subject can understand and sign an informed form 
ix) 
Provision of written informed consent 
 
Exclusion 
i) Subjects who are unable to understand the written and 
verbal instructions in local language 
ii) Breech presentation and other abnormal fetal presentations
iii) 
Previous uterine scar 
iv) Spontaneous rupture of membranes at inclusion 
v) Pathologic CTG at inclusion  
vi) Fetal estimated weight > 2SD of normal fetal estimated 
weight 
earlier 
diagnosed 
by 
ultrasound 
and 
documented in patient record  
vii) Mother’s BMI > 35 at early pregnancy 
viii) Known IUGR defined as ≤ 2SD of normal 
ix) Presence of eclampsia  
x) Severe Pre-eclampsia  
xi) HELLP syndrome (hemolysis, elevated liver enzymes, and 
low platelets) 
xii) Clinically significant vaginal bleeding in need of 
hospitalization in the third trimester  
xiii) Placenta previa  
xiv) Previously known coagulation disorders (Leiden, 
heterozygote - OK) 
xv) Treatment with a heparin/LMWH product during the 
previous six months 
xvi) Current use of any drugs that interfere with hemostasis 
such as oral anti-coagulant medication, non-steroidal 
anti-inflammatory drugs (NSAID) compounds and 
vitamin K antagonists. 
xvii) Current use of acetylsalicylic acid (ASA) compounds 
or use within the week preceding inclusion  
xviii) Diagnosed with HIV or Acute hepatitis 
xix) Known history of allergy to standard heparin
   and/or LMWH heparin 
xx) History of heparin-induced thrombocytopenia 
xxi) Current drug or alcohol abuse which in the opinion
of the Investigator should preclude participation in
the study.  


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5 
xxii) Current participation in other interventional medicinal 
treatment studies 
xxiii) Subject has a fear of needles which is believed by the 
 
Investigator to affect study medication compliance 
xxiv) Any 
relevant 
condition, 
laboratory 
value 
or 
concomitant medication which, in the opinion of the 
investigator, makes the subject unsuitable for entry into 
the 
study
 
Methods & procedures 
Subjects who enter into ≥ 37 weeks of gestation may be subject 
to the informed consent procedure. 
 
If the subject is found to be eligible for the study, she will be 
randomized to study treatment with the Investigational Medicinal 
Product (IMP)  
Part A - a proof of concept study 
The daily study treatment will be 300 mg of tafoxiparin or 
placebo for at least 4 days and up to 7 days 
 
Part B - to be initiated after a positive result from Part A study 
The daily study treatment will be 150 mg tafoxiparin or 75 mg of 
tafoxiparin/placebo for up to at least 4 days and up to 7 days  
 
After Randomization/inclusion in the study the following must 
be recorded at any stage during the study: 
• new adverse event or changes to pre-existing adverse 
events according to instructions 
• concomitant medications according to instructions 
 
Screening and Baseline  
Upon the provision of informed consent, the subject will undergo 
the study-specific screening procedures where cervical palpation, 
vital signs (BP and HR) will be recorded.  
Data regarding demographics and habits, expected date of 
delivery and gestational age, medical history and 
previous/concomitant medication will be collected by interview 
and from subject’s records.  
The Investigator will perform a review of the eligibility criteria. 
Blood samples will be collected for laboratory determination of 
hematology and clinical chemistry  
A cardiotocographic (CTG) tracing according to clinical practice 
should be carried out. 
The subject will be randomized to study treatment, included in 
the study and given the first dose of IMP (tafoxiparin/placebo)


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6 
If more than 24 hours has passed between screening and 
randomization, a CTG tracing, cervical palpation and BP and HR 
recordings will be repeated prior to treatment with IMP. 
The subject is included in the study when study treatment is 
initiated by the first injection of the IMP 
 
Study treatment and Induction of Labor 
Before every daily dosing instance, a cardiotocographic (CTG) 
tracing according to clinical practice should be carried out and 
BP and HR recordings performed. 
Thereafter the subject will receive the SC injections of the IMP.  
Cervical palpation should be performed daily. 
Membrane sweeping to initiate labor should not be done. 
 
Part A 
The daily dose of tafoxiparin will be 300 mg   
 
Part B 
The daily dose of tafoxiparin will be 150 mg tafoxiparin or 75 
mg of tafoxiparin  
 
The study medication will be administered subcutaneously in the 
abdominal or hip region for up to a total of 7 days or until partus. 
 
After the fifth dose of IMP has been given, prior to labor 
induction and immediately prior to any epidural anesthesia, a 
blood sample for hematology status, including thrombocyte 
count, should be taken.  
 
The result from the fifth dose sample should be reviewed before 
the next dose is given. If one of the following two criteria are 
fulfilled, the IMP treatment should be terminated: 
1. The thrombocyte count value is reduced by 50% or more 
from the screening/baseline value. 
2. The actual thrombocyte count value is below 70x109/L. 
 
The result from the blood sample taken prior to epidural 
anesthesia should be reviewed before the epidural anesthesia 
procedure is initiated. 
 
In a situation where HIT is suspected, a HIT antibody test should 
be performed, and if positive, a hematologist shall be contacted 
for further testing and appropriate treatment 
 
If the HIT test is positive, the event should be classified and 
reported as a SAE. 
 


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Response group I 
Subjects who enter into spontaneous labor after 1-7 doses of IMP 
should be managed according to clinical practice 
Response group II 
Subjects who are given 4-7 doses without entering into 
spontaneous labor, but with a ripe cervix (Bishop/Westin score 
≥6) should be induced into labor by amniotomy and oxytocin 
treatment, but preferably not before 4 treatment doses have been 
given. 
Response group III 
Subjects who are given 7 doses of IMP without entering into 
spontaneous labor and with an unripe cervix shall be treated with 
a cervical balloon catheter provided by the hospital according to 
instructions provided by the sponsor. The balloon should stay in 
the cervix until it is expelled or up to 24 hours. If the cervix is 
still unripe after 24 hours of balloon treatment, the subject should 
be given PGE-1 treatment orally according to clinical routine. 
When the cervix is ripe (Bishop/Westin score ≥6), they should be 
induced into labor according to clinical practice. If they do not 
enter into labor after PGE-1 and oxytocin treatment they should 
be managed at the discretion of the treating physician.  
A CTG recording should be performed in relation to PGE-1 
treatment according to clinical practice. 
Abnormal CTG with signs of hypercontractility will be treated 
according to clinical routines and with tocolytics if needed. 
Response group IV 
The subject must be induced into labor due to medical reasons or 
subjects demand before 7 doses of IMP have been given and the 
cervix is still unripe. They should be managed according to 
clinical practice. 
 
Labor  
Onset of labor is defined as last record of 4 cm cervical dilatation 
visualized in the partogram and progress of labor or last record 
of 4 cm of cervical dilatation in combination with amniotomy 
and intravenous administration oxytocin 
CTG registration will be performed continuously during 
established labor according to clinical practice. 
If slow progress of labor (cervical dilation < 1cm per/hour during 
3 hours) or labor arrest (no progress during 3 hours) occur in 
patients who are not yet on oxytocin treatment, they should be 
given oxytocin treatment according to clinical practice. 
The characteristics of the new-born baby will be evaluated and 
recorded.  
Blood sample from arterial or venous umbilical cord will be 
collected for analyses of pH and/or Base Excess. 
After labor, the subject will remain at the clinic as per clinical 
practice until the Discharge. 


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8 
Study drug injection site reactions (Skin discoloration < 3 cm in 
diameter should not be reported as AE)  
 
Discharge  
At discharge, evaluations specific for the Discharge shall be 
performed.  
Any changes to, or new concomitant medications or the 
occurrence or changes to any pre-existing adverse events for 
both the mother and the infant will be evaluated and reported.  
The mother’s BP and HR should be recorded 
 
A blood sample for hematology status including thrombocyte 
count should be taken.  
 
If one of the following two criteria are fulfilled, a HIT antibody 
test should be performed. 
1. 
The thrombocyte count value is reduced by 50% or more 
            from the baseline value. 
2. 
The actual thrombocyte count value is below 70 109/L. 
 
In a situation where HIT is suspected, a HIT antibody test should 
be performed, and if positive, a hematologist shall be contacted 
for further testing and appropriate treatment. 
 
If the HIT test is positive, the event should be classified and 
reported as a SAE. 
 
Any potential events requiring NICU admission and neonatal 
diagnoses will be specifically recorded.  
Permission to review the infant’s hospital charts from the 
pediatric and other relevant departments will be requested. 
 
Withdrawal from Treatment and Study 
There will be two types of withdrawals from the study:  
• complete withdrawal (e.g., due to withdrawal of informed 
consent or lost to follow-up) or  
• withdrawal from study medication (e.g., unacceptable 
adverse events or Investigator’s discretion). 
The adherence to the protocol may be aborted if there is 
significant deterioration in the condition of the mother or the 
fetus that would make it unwise to continue the induction 
attempt.  
All subjects who prematurely discontinue participation in the 
study (complete withdrawal) should not receive any additional 
doses of study medication or perform any subsequent clinic 
visits. The Investigator should, however, make an effort to 
contact the patient and obtain the reason for discontinuation from 


Conﬁdenal/Clinical Study Protocol PPL17 – Dilafor 
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9 
the study. All subjects who prematurely discontinue the study for 
whichever reason (withdrawals from investigational product), 
shall not receive any additional doses of study medication, 
independent of the reason for withdrawal. However, they will be 
asked to complete all subsequent planned safety and efficacy 
evaluations.   
Subjects who are withdrawn for whichever reason after 
randomization but prior to receiving the first dose of study drug 
may be replaced at the discretion of the Sponsor.  
 
Medications and Procedures Excluded during the Study 
The medications, devices and procedures which are prohibited 
from use during the study include, but are not limited to, the 
following: 
• Use of drugs that interfere with hemostasis, including 
heparin / LMWH, direct oral anti-coagulant drugs, non-
steroidal anti-inflammatory drugs (NSAID) compounds 
and vitamin K antagonists 
• Use of acetylsalicylic acid (ASA) from one week prior to 
Screening until partus. 
NSAID and heparin/LMWH may be used postpartum according 
to clinical practice. 
Medication 
(dose, route,  
duration) 
Test/ 
placebo 
Part A 
Tafoxiparin/Placebo will be supplied to the site as kits designed 
to constitute 300 mg of tafoxiparin or placebo to be given as SC 
injection daily for up to 7 days. The active substance will be 
delivered in 2 ml vials containing a minimum extractable volume 
of 1.6 ml of 150mg/ml of tafoxiparin. Apart from tafoxiparin, 
each ml of study drug will constitute 0.015 M phosphate buffer. 
The study medication kit for each patient will contain 8 doses (2 
vials per dose) with one dose labeled reserve dose in case a dose 
is rendered unusable. The investigational product will be 
administered subcutaneously every 24±3 hours by the site staff 
for up to 7 days. At each dosing time 1.0 ml of the drug will be 
extracted from each of the two vials and injected as separate s.c. 
injections.  
Test/ 
placebo 
Part B 
Tafoxiparin/Placebo will be supplied to the site as kits designed 
to constitute 150 mg or 75 mg of tafoxiparin or placebo to be 
given daily by SC injection.  The active substance will be 
delivered in 2 ml vials containing a minimum extractable volume 
of 1.6 ml of 150mg/ml of tafoxiparin. Apart from the active 
substance, each ml of study drug will constitute 0.015 M 
phosphate buffer. The study medication kit for each patient will 
contain 8 doses (2 vials per dose). For the subjects randomized to 
150 mg of tafoxiparin per day the IMP kits will contain two vials 
of tafoxiparin. For the subjects randomized to 75 mg of 


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10 
tafoxiparin per day the IMP kits will contain one vial of 
tafoxiparin and one vial of placebo. The investigational product 
will be administered subcutaneously every 24±3 hours by the site 
staff for up to 7 days. At each dosing occasion 0.5 ml of the drug 
will be extracted from each of the vial and injected as separate 
s.c. injections.  
Comparator 
Matching placebo saline solution will be supplied to the site 
containing of 9 mg/ml of sodium chloride (NaCl) solution. The 
placebo saline solution will be indistinguishable from the active 
solutions in appearance, smell and packaging.  
Non- 
investigatio
nal product 
PGE-1 medications for oral administration will be supplied by 
the investigators. The treatment will be given according to 
clinical practice. Cervical balloon catheters will be supplied by 
the hospital and used as described in the protocol. 
Statistics 
Sample size 
The sample size estimation for the PPL17 study is based on a 
parallel-group comparison of effect between placebo and 
tafoxiparin on the primary endpoint. Thus, the sample size is 
based on Part A (the efficacy part of the study).     
  
Sample size calculation is based on the following: 
Totally 170 patients (85 in each group) are required to have an 
80% power of detecting, as significant at the 5% level, an 
increase in the primary endpoint from 0.5 Bishop score points 
per 7 days in the placebo group to 1.5 Bishop score points per 7 
days in the tafoxiparin group assuming a common standard 
deviation (SD) of 2.3 Bishop score points.  
 
If the efficacy and safety profiles of Part A are conclusive in 
favor of tafoxiparin, 82 women will be included in each of two 
additional tafoxiparin dose groups in Part B. 
Methods 
The main analysis is planned when all patients have completed 
the study, all data have been entered, verified and validated, and 
the database has been locked. 
  
Primary analyses (Efficacy): 
The primary efficacy endpoint is “Cervical ripening rate during 
up to the first seven days of treatment, measured by Bishop 
score” 
 
The primary efficacy endpoint will be analyzed using a linear 
mixed effects model with random intercept and random slope.  
Time-to-event outcomes will be analyzed using a Weibull model 
with treatment and stratification factors as independent factors. 
Kaplan-Meier plots of the time from onset of labor to partus for 


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11 
each treatment group will be presented. Cox regression will also 
be performed as sensitivity analyses. 
Dichotomous endpoints will be analyzed using logistic 
regression.  
Other efficacy and safety variables will be presented with 
descriptive statistics such as mean, standard deviation, median, 
minimum and maximum for continuous variables, and number 
and percentages for discrete variables. 
 
Secondary analysis (Safety and Tolerability): 
Safety and tolerability will be analyzed using descriptive 
statistics on the primary endpoints. No formal statistical tests will 
be performed. Means, medians, ranges and standard deviations 
will be presented by treatment group for continuous endpoints, 
while counts and percentages will be presented for categorical 
endpoints.  
 
Statistical Analysis Plan 
In addition to the summarized analysis plan outlined above, a 
separate document - Statistical Analysis Plan for PPL17 - will 
detail all analysis to be performed.  
 
Subgroup analyses: 
The subgroups and the analyses performed on the subgroups will 
be elaborated in the Statistical Analysis Plan. 


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Schedule of events 
Control/visit 
Screening  
- 24-0h 
Baseline 
0h 
Day 5 
IMP treatment for up to 7 
days 
Induction  
(if relevant) 
EDA if relevant 
 
Established Labor 
 
Discharge 
 
Informed Consent 
X 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
Xa 
 
 
 
 
 
Medical History and Concomitant Diseases 
X 
 
 
 
 
 
 
Vital Signs  
X 
Xa 
 
X 
X 
X 
X 
Cervical Palpation 
X 
Xa 
 
X 
X 
X 
 
Randomization 
 
X 
 
 
 
 
 
Study Drug Administration 
 
X 
 
X 
 
 
 
Injection site reactions 
 
 
 
X 
X 
 
X 
Induction of Labor 
 
 
 
 
X 
 
 
Labor Characteristics - Partogram 
 
 
 
 
 
X 
 
Fetus/Infant Status including CTG 
X 
Xa 
 
Xc 
X 
X 
Xb 
Hematology and Clinical Chemistry 
X 
 
Xd 
 
X, Xe 
 
Xd 
Umbilical cord blood  
 
 
 
 
 
X 
 
Concomitant Medication (Mother) 
X 
Xa 
 
X 
X 
X 
X 
Concomitant Medication (Infant) 
 
 
 
 
 
X 
X 
Adverse Events (Mother and Fetus/Infant) 
 
 
 
X 
X 
X 
X 
a If Baseline occurs ≤ 24 hours after Screening, these data will not be re-checked, b No CTG, c Prior to dosing d Hematology status including thrombocyte count e Only 
hematology prior to labor induction and immediately prior to epidural anesthesia