Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2a, Double-blind, Parallel Group, Randomised, Placebo Controlled, Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of OBE022 added-on to Atosiban, After Oral Administration in Pregnant Women With Threatened Spontaneous Preterm Labour
Brief Summary: This is a proof-of-concept study in 2 parts.

In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between 28 0/7 and 33 6/7 weeks.

Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre design and will assess the efficacy, safety and pharmacokinetics in pregnant women with threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks.

All patients in part A and part B must receive atosiban infusion for 48 hours as standard of care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.


Options:
A: Inclusion Criteria:

* Pregnancies with intact membranes in confirmed preterm labor;
* 20 - 32 weeks' gestation;
* Cervical dilatation 0 - 3cm versus 4 - 6cm;
* No conditions contraindicating continued pregnancy (severe IUGR, chorioamnionitis, non-reassuring fetal tracing - physician judgement); AND
* Able and willing to consent to the study protocol.

Exclusion Criteria:

* Failure to meet admission criteria;
* Known serious fetal malformations;
* Severe maternal/obstetric disease affecting the mother or fetus (severe cardiac disease, placental abruption/previa, severe diabetes, severe preeclampsia, etc. - physician judgment);
* Allergic to magnesium, antiprostaglandin or calcium channel antagonist;
* Refusal or inability to consent to the study
B: Inclusion Criteria:

* Pregnant women between 24 and 34 weeks of gestation.
* Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less

Exclusion Criteria:

* All contraindications for tocolysis (fetal distress, abruptio placenta).
* Multiple pregnancy.
* All contraindications for the use of any of the two drugs (indomethacin or nifedipine).
C: Key Inclusion Criteria:

Part A

* Pregnant females aged ≥ 18 years
* Patients with a singleton or twin pregnancy
* Gestational age between 28 0/7 and 33 6/7
* Administered or prescribed atosiban for the treatment of preterm labour

Part B

* Pregnant females aged ≥ 18 years
* Patients with a singleton or twin pregnancy
* Gestational age between 24 0/7 and 33 6/7
* Administered or prescribed atosiban for the treatment of preterm labour
* ≥4 uterine contractions per 30 minutes
* Cervical dilatation of 1 to 4 cm inclusive
* At least one of the following signs of preterm labour:

  1. positive IGFBP-1 or fœtal Fibronectin test
  2. cervical length ≤ 25mm
  3. progressive cervical change

Key Exclusion Criteria:

* Fœtal death in utero in current or previous pregnancy after gestational week 24 or expected high risk of fœtal death in the coming days
* Oligohydramnios
* Known pathological Doppler ultrasound of the umbilical artery
* 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:

  1. Premature rupture of membranes
  2. Evidence or suspicion of abruptio placenta
  3. Signs and/or symptoms of chorio-amnionitis
  4. Pre-eclampsia, eclampsia or HELLP-syndrome
* Use of cervical cerclage in the current pregnancy or a pessary in situ
* Current use of anti-hypertensive medication
* Treatment with other tocolytics within specified time before the baseline assessment of uterine contractions
D: Inclusion Criteria:

* Women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old.

Exclusion Criteria:

* Cervical dilatation of ≥ 6 cm
* Maternal contraindication to tocolysis
* Known fetal anomalies
* Suspected chorioamnionitis
* Nonreassuring fetal heart tracing
* Vaginal bleeding due to placenta previa or abruptio placenta
* Preterm premature rupture of membranes
* Prolapsed membranes
* Human immunodeficiency virus positive
* Multiple gestation
* Patients on procardia within 24 hours of po intake
* Magnesium sulfate tocolysis prior to randomization
* Patient refusal

Answer: C