Please select the eligibility criteria that correspond to the clinical trial below.
Title: ADMINISTRATION OF NIFIDEPINE VERSUS ATOSIBAN IN PREGNANT WOMEN WITH A THREAT OF PREMATURE LABOR
Brief Summary: This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The principal aim of this study is to compare the efficacy and safety of Nifedipine treatment versus Atosiban treatment over these patients' newborn babies.


Options:
A: Inclusion Criteria:

* Patients between 240/7-320/7 weeks gestation with findings consistent with preterm labor defined by at least one of the following criteria in accordance with regular uterine contractions (\>4 uterine contractions in 20 minutes):

  1. Cervix \> 2 cm in dilation or 80% effaced
  2. Positive fetal fibronectin (if performed).
  3. Demonstrated cervical change between two exams within 90 minutes.

Exclusion Criteria:

* Negative fetal fibronectin
* \> 5cm dilatation
* Multiple gestations
* Known fetal anomalies or chromosomal abnormalities
* Ruptured membranes
* Significant vaginal bleeding
* Suspected chorioamnionitis
* Preeclampsia or uncontrolled hypertension
* Non-reassuring fetal heart tracing
* Placenta previa and/or accreta
* Placenta abruption
* Intrauterine growth restriction
* Maternal renal disease
* Underlying maternal cardiac condition
* Symptomatic hyperthyroidism
* Significant maternal disease
* Contraindication to nifedipine or magnesium
* Cerclage presence
* Tocolytic use within the last 12 hours
* Hypotension (defined as average blood pressure of \<70/40's unresponsive to 1000 cc fluid bolus
B: 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
C: Inclusion Criteria:

The study population and the inclusion criteria is established by patients between the 24th and 33+6th weeks of pregnancy, fixed by an ecography during the first three-month period, and with a threat of preterm labor (TLP), by the American College of Obstetricians and Gynecologists (ACOG's) criteria:

* Four contractions or more with a duration of at least 30 seconds during 30 minutes
* Documented cervix changes:

  * The cervix changes in a nulliparous woman are: both cervix tact with 0 to 4 cm of dilatation and cervical effacement of at least a 50% (vaginal ultrasound alternative with cervix length two standard curvatures under the average for the gestational age)
  * The cervix changes in a multiparous woman are: 1 to 4 cm of dilatation and cervical effacement of at least a 50% (same ecographic alternative as the nulliparous).
* Patient who had signed the informed consent.

Exclusion Criteria:

Exclusion criteria of the pregnant mother and intrauterine fetal:

* Prior treatment with a different tocolytic from the ones in the protocol.
* Chorioamnionitis.
* Premature rupture of membranes.
* Vaginal Bleeding.
* Major fetal malformations.
* Intrauterine growth retardation (IGR): IGR\<percentile 5.
* Cardiopathies (aortic stenosis, congestive heart failure).
* Blood Pressure lower than 100/60 mmHg.
* High transaminase levels.
* Uterine malformations.
* Use of magnesium sulphate.
* Severe hypertensive disorder, defined as blood pressure equal to or greater than 160/100 mmHg or any figure associated with severe preeclampsia.
* Non-reassuring cardiac frequency tracing defined as category II and III of National Institute of Child Health and Human Development (NICHD).
* Asthmatic patients treated with betamimetics.
* Hypertensive patients treated with vasodilators.
* Patient in treatment or treated with another product/s in investigation during the four weeks prior to randomization.
* Hypersensitivity to any drug of the study.
D: Inclusion Criteria:

* Singe fetus
* Gestational age between 24+0/7 and 31+6/7
* At least one uterine contraction in ten minutes for at least 20 minutes upon tocography admission
* Cervical parameters: 1 cm dilation or more or 80% cervical effacement or cervical length 20mm or less

Exclusion Criteria:

* Rupture of membranes
* Vaginal bleeding
* Cervical dilation ≥5cm
* Known fetal malformations
* Fetal heart rate abnormalities
* Suspected placental abruption of adherent placental syndrome
* Known sensitivity to one of the drugs used in the study (Indometacin and nifedipine)
* Maternal hypotension and known aortic or mitral stenosis
* Presence of cervical cerclage
* Previous administration of tocolytic drugs in current pregnancy

Answer: C