OBE022 added-on to atosiban in threatened spontaneous preterm labour, Proof of Concept study.
- Conditions
- oral treatment of threatened spontaneous preterm labour in weeks 24 to 34 of pregnancyMedDRA version: 20.0 Level: LLT Classification code 10075863 Term: Preterm labor System Organ Class: 100000004868Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2017-002579-25-ES
- Lead Sponsor
- ObsEva SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 130
Part A
1. Provision of written informed consent to participate as shown by a signature on the patient consent form
2. Be able and willing to comply with the requirements of the protocol
3. Pregnant females aged > or = 18 years
4. Patients with a singleton or twin pregnancy
5. Gestational age between 28 (0/7) and 33 (6/7), as confirmed by a first trimester ultrasound scan or fertilization date. In situations where this information is not readily available, Investigator may use best clinical judgement or verbal history from the patient to be confirmed through medical records as soon as possible after randomization
6. Administered or prescribed atosiban for the treatment of preterm labour (note that IMP treatment should be initiated ideally simultaneously or at a maximum within 24 h after atosiban start)
Part B
1. Provision of written informed consent to participate as shown by a signature on the patient consent form
2. Be able and willing to comply with the requirements of the protocol
3. Pregnant females aged > or = 18 years.
4. Patients with a singleton or twin pregnancy
5. Gestational age between 24 (0/7) and 33 (6/7), as confirmed by a first trimester US scan or fertilization date. In situations where this information is not readily available, the Investigator may use best clinical judgement or verbal history from the patient to be confirmed through medical records as soon as possible after randomization
6. > or = 4 uterine contractions per 30 minutes, measured by electrohysterography, tocodynamometry or abdominal palpation
7. Cervical dilatation of 1 to 4 cm inclusive
8. At least one of the following consequences of preterm labour:
a) positive IGFBP-1 or fœtal Fibronectin test
b) cervical length < or = 25mm
c) progressive cervical change
9. Administered or prescribed atosiban for the treatment of preterm labour (note that IMP treatment should be initiated ideally simultaneously or at a maximum within 24 h after atosiban start)
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 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
To be eligible for inclusion in this study the patients must not meet any of the following criteria:
1. Fœtal death in utero in current or previous pregnancy after gestational week 24 or expected high risk of fœtal death in the coming days
2. Fœtal weight outside 2 standard deviations for GA based on ultrasound
3. Oligohydramnios
4. Pathological Doppler ultrasound of the umbilical artery
5. Any contraindications for the mother or the fœtus to stop labour or prolong pregnancy or any maternal or fœtal conditions likely to indicate iatrogenic delivery in the next 7 days, including but not limited to:
a) Premature rupture of membranes
b) Evidence or suspicion of abruptio placenta
c) Signs and/or symptoms of chorio-amnionitis
d) Pre-eclampsia, eclampsia or HELLP-syndrome
6. Any condition which in the opinion of the Investigator constitutes a risk or a contraindication for the participation of the patient in the trial or that could interfere with the trial objectives, conduct or evaluation, including:
a) Any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT, alkaline phosphatase or total bilirubin > ×2 ULN for women taking into account gestational age
b) Any clinically significant and trial relevant abnormality in the results of the screening physical examination including a gynaecological examination
7. The patient has known positive results from virology tests for HBsAg (not due to vaccination), HCV or HIV 1 or 2. However, patients who have resolved hepatitis B infection may be enrolled in the study
8. The patient had a BMI > or = 35 kg/m2 prior to start of current pregnancy or had a bariatric surgery
9. Any condition likely to hinder drug absorption
10. Use of cervical cerclage in the current pregnancy or a pessary in situ
11. Current use of anti-hypertensive medication
12. Treatment with other tocolytics within specified time before the baseline assessment of uterine contractions i.e.
a) nifedipine (not long acting) in the previous 6 hours
b) ritodrine, fenoterol, other betamimetics, indomethacin, other oral or injectable NSAIDs, long acting nifedipine, other calcium channel blockers, and nitric oxide donors in the previous 24 hours
c) nicardipine in the previous 2 weeks
13. Known allergy or hypersensitivity to the active substance or any of the ingredients of the study drug
14. History of or current (within the past 12 months) known problem with alcohol or drug abuse
15. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of uncooperative attitude
16. Currently participating or have participated in another clinical trial (investigational drug or medical device) within 30 days prior to screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method