Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Multifetal Gestation (STTARS)
Brief Summary: Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a treatment that substantially reduces the rate of preterm birth in women at high risk for preterm delivery (i.e. progesterone therapy). Preterm birth was reduced by 35% among progesterone-treated women with a singleton pregnancy when compared with women receiving placebo. The current trial compares weekly treatment by injection of progesterone with placebo in women pregnant with twins or triplets.


Options:
A: Inclusion Criteria:

* Pregnancy 20 - 34 weeks; cervical dilation \<4 cm; risk for preterm birth; multifetal gestation; diagnosis of preterm labor during the current pregnancy effectively tocolyzed); preterm rupture of the fetal membranes (24 - 34 weeks); willing and able to sign Informed Consent Form

Exclusion Criteria:

* Failure to meet inclusion criteria as noted above; contraindication to pregnancy continuation; severe medical diseases such as sickle cell disease with crises, diabetes mellitus (F/R/H), severe preeclampsia etc., (physician judgment; severe fetal/obstetric criteria such as intrauterine growth restriction (\<5th percentile, placental abruption,placental previa, etc., (physician judgment); non reassuring fetal assessment; allergy to progesterone compounds; refusal to participate
B: Inclusion Criteria:

1. Participant is 18 years old or older
2. Gestational Age (GA) 23w0d and 30w6d @ time of enrollment
3. Singleton pregnancy
4. PROM defined as either (a) or (b) or (c) below (a) Documentation of vaginal leakage of indigo carmine dye instilled via amniocentesis (b) Positive Amnisure® test (c) Two or more of (i) through (iv): i. Nitrazine test with pH of 7 or more ii. Positive fern test iii. Gross pooling of clear fluid iv. US exam showing oligohydramnios

Exclusion Criteria:

1. Any contraindication to expectant management
2. Any fetal condition likely to cause serious neonatal morbidity independent of gestational age
3. History of allergy to 17P
4. Any contraindications to 17P use (e.g. Thrombosis, Breast CA, abnormal vaginal bleeding unrelated to pregnancy, jaundice, liver disease, uncontrolled HTN)
5. Any medical condition currently treated with systemic steroid medications
6. Cervical cerclage present at the time of PROM
7. Informed consent not obtained.
C: Inclusion Criteria:

* Twin or triplet pregnancy. Quadruplets reduced to triplets may be included, but no other prior reductions.
* Gestational age between 16 weeks 0 days to 20 weeks 6 days based on clinical information and evaluation of the first ultrasound.
* Signed patient authorization and consent form.

Exclusion Criteria:

* Prior elective fetal reduction in the current pregnancy, except in the case of a quadruplet gestation reduced to triplets.
* Planned fetal reduction or planned termination
* Monoamniotic gestation
* Twin-twin transfusion syndrome
* Fetal death or imminent fetal demise
* Major fetal anomaly (e.g., gastroschisis, spina bifida, serious karyotypic abnormalities). An ultrasound examination from 12 weeks 0 days to 20 weeks 6 days by project estimated date of confinement (EDC) must be performed to rule out fetal anomalies
* Discordance in fetal size, defined as a discrepancy of 3 or more weeks in gestational age by ultrasound between the largest and the smallest fetus. Diagnosis is based on measurements made at the ultrasound done between 12 weeks 0 days and 20 weeks 6 days gestation
* Progesterone treatment used or planned after 14 weeks gestation
* Heparin therapy at a dose ≥ 10,000 units per day of unfractionated heparin, or any low molecular weight heparin during the current pregnancy, or thromboembolic disease for which such heparin treatment is planned (because of contraindication to intra-muscular injections)
* Current or planned cervical cerclage
* Uterine anomaly (uterine didelphys, bicornate uterus)
* Contraindication to intra-muscular injections
* Maternal medical conditions, such as: known idiopathic thrombocytopenia purpura (ITP) or a known platelet count less than 100,000 per cubic millimeter (because of contraindication to intra-muscular injections), hypertension requiring medication, diabetes managed with insulin or oral hypoglycemic agents
* Inability to arrange a pre-randomization ultrasound between 12 weeks 0 days and 20 weeks 6 days gestation
* Participation in another interventional study that influences gestational age at delivery or neonatal morbidity or mortality
* Prenatal follow-up or delivery planned elsewhere (unless the study visits can be made as scheduled and complete outcome information can be obtained)
* Participation in this trial in a previous pregnancy.
D: Inclusion Criteria:

* Twin pregnancy
* Informed consent
* 18-23 weeks' gestation
* Participants must be fluent in the language spoken in the respective centres

Exclusion Criteria:

* Age \< 18 years
* Known allergy to progesterone or peanuts
* Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders
* Rupture of membranes at the time of inclusion
* Monoamniotic twins
* Pregnancies treated for or with signs of twin-to-twin transfusion syndrome at inclusion
* Multiple pregnancies reduced to twin pregnancies
* Known significant structural or chromosomal fetal abnormality
* Chorionicity not assessed before 15 weeks
* Known or suspected malignancy in genitals or breasts
* Known liver disease

Answer: C