Study to Evaluate the Effect of continuous infusion of Tafoxiparin to treat Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest

Phase 1

• Conditions: Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest; MedDRA version: 20.0 Level: LLT Classification code 10023539 Term: Labor abnormal System Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-002118-40-FI
• Lead Sponsor: Dilafor AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-16
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

1.Pregnant women of =18 to =45 years of age
2.Nulliparous
3.Gestational age > 36 weeks + 6 days confirmed by ultrasound
4.Experience slow progress of labor including prolonged latent phase and Primary labor arrest (according to the respective definitions)
5.Normal CTG at inclusion
6.Singleton pregnancy
7.Subject is as per the discretion of the Investigator, considered healthy and able to comply with the requirements of the protocol
8.Provision of written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects with secondary slow progress or secondary labor arrest
2.BMI=35 during first trimester of pregnancy
3.Breech presentation or other abnormal presentations
4.LGA (Large for Gestational Age) defined as = to normal weight earlier diagnosed by ultrasound and documented in patient record
5.Small for gestational age (SGA) defined as =-2SD to normal weight earlier diagnosed by ultrasound and documented in patient record
6.Presence of eclampsia
7.Severe preeclampsia, defined as severe by the [ACOG Committee Preeclampsia and Eclampsia (2002)] as preeclampsia with any or more of the following characteristics present:
- Blood pressure of =160 mmHg systolic or =110 mmHg diastolic on two occasions at least 6 hours apart while the patient is on bed rest
- Proteinuria of 5 g or higher in a 24-hour urine specimen or 3+ greater on two random urine samples collected at least 4 hours apart
- Oliguria of less than 500 mL in 24 hours
- Cerebral or visual disturbances
- Pulmonary edema or cyanosis
- Epigastric or right upper-quadrant pain
- Impaired liver function
- Thrombocytopenia
8.HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets)
9.Clinically significant vaginal bleeding in the third trimester
10.Diagnosed renal insufficiency
11.Previously known coagulation disorders, including but not limited to:
- Von Willebrand’s disease
- Haemophilia A/B
- Antithrombin deficiency
- Vitamin K deficiency
12.Previously known coagulation defects, including but not limited to:
- Prolonged activated partial thromboplastin time (APTT)
- Thrombocytes <100 x 109/L
13.Current use of any drugs that interfere with hemostasis, including heparin / LMWH, non-steroidal anti-inflammatory drugs (NSAID) compounds, warfarin and vitamin K antagonists
14.Current use, or use within the week preceding screening, of acetylsalicylic acid (ASA) compounds
15.Previously known current infections (HIV or hepatitis)
16.Any known history of allergy to standard heparin and/or LMWH heparin
17.History of heparin-induced thrombocytopenia
18.Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study
19.Current participation in other clinical treatment studies
20.Previous uterine scar (e.g. myomectomy)
21.Labor induction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified