Please select the eligibility criteria that correspond to the clinical trial below.
Title: Progestagens for the Tertiary Prophylaxis of Preterm Delivery in Women With Short Cervix. A Randomized Multicentre Trial
Brief Summary: Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and 17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of cervical shortening, in the present pregnancy.

Main outcome: Delivery before 37 weeks.

Secondary outcomes: Gestational age at delivery, Delivery \<32, \<35 wks, hospital admissions before delivery, birth-weight centile, NICU admission, days of NICU admission, days of oxygen supply, composite neonatal complications, congenital neonatal malformations and anomalies.

Allocated treatments will be:

Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical observation

Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg repeated once 24 hours apart) will be permitted. Is not allowed the treatment with tocolytics per os. Any treatment will be recorded.

Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit will be competitively assigned later. Results are expected 20-24 months from starting.

Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50% (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160 patients/arm, with a total of 480 patients.

Data analysis: Methodological Unit will assign randomized treatment through a web site and it will collect data through the same way.


Options:
A: Inclusion Criteria:

* Age: 24-37
* Gestational week: 7- 12
* Evidence of threatened miscarriage (pelvic pain with or without vaginal bleeding)
* Ultrasound evidence of subchorionic hematoma

Exclusion Criteria:

* Lack of fetus
* Absence of fetal heart tone
* Uterine anomaly or fetal anomaly
* Presence of multiple pregnancy
* Gestation pathology
* Therapies with anti-coagulants or anti-hypertensive drugs
B: Inclusion Criteria:

* Age of women from 18-40 years at the time of recruitment (not beyond 40th birthday)
* Absence of fever
* Gestation less than 12 completed weeks as defined by pelvic ultrasound
* Presence of intrauterine gestational sac(s) if an urine pregnancy test is first positive within past 2 weeks
* Presence of intrauterine fetus(es) with crown-rump length of \<7mm and no fetal pulsation, or presence of intrauterine fetus(es) with positive fetal heart pulsation confirmed on pelvic scanning

Exclusion Criteria:

* Age of women \>40 years at the time of recruitment
* History of recurrent miscarriage defined as at least three consecutive spontaneous miscarriages
* History of known parental chromosomal abnormalities
* Heavy vaginal bleeding requiring surgical intervention
* Severe abdominal pain requiring surgical intervention
* Absence of cardiac pulsation in a fetal pole with crown-rump length of \>=7mm on transvaginal scanning
* Use of hCG or progesterone treatment for threatened miscarriage prior to recruitment
C: Inclusion Criteria:

* 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
* Meet legal criteria to obtain abortion
* Present with closed cervical os and no vaginal bleeding
* Live fetus at time of presentation for service
* Have no contraindications to study procedures, according to provider
* Be able to consent to procedure, either by reading consent document or by having consent document read to her
* Be willing to follow study procedures

Exclusion Criteria:

* Known previous transmural uterine incision
* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery, including placenta previa
* Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
D: Inclusion Criteria:

* Women with singleton pregnancy at 22+0nd to 31+6nd week of gestation presenting with a cervical length ≤25 mm, after an episode of preterm labour.

Exclusion Criteria:

* Women with previous spontaneous PTD, multiple pregnancy, rupture of membranes, feto-maternal conditions indicating delivery, mullerian malformations, cervical surgery (cervical cerclage etc), presence of regular uterine contractions

Answer: D