Please select the arm or intervention descriptions that belong 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: Arm Label: Lipoic acid; Type: EXPERIMENTAL; Interventions: Device: Lipoic acid | Arm Label: Progesterone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Progesterone | Intervention Type: DEVICE; Name: Lipoic acid; Assigned to Arm(s): Lipoic acid | Intervention Type: DRUG; Name: Progesterone; Assigned to Arm(s): Progesterone
B: Arm Label: Dydrogesterone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dydrogesterone | Arm Label: Placebo pill; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Dydrogesterone; Assigned to Arm(s): Dydrogesterone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo pill
C: Arm Label: mifepristone+misoprostol; Type: EXPERIMENTAL; Interventions: Drug: mifepristone+misoprostol | Arm Label: misoprostol; Type: ACTIVE_COMPARATOR; Interventions: Drug: misoprostol+placebo | Intervention Type: DRUG; Name: mifepristone+misoprostol; Assigned to Arm(s): mifepristone+misoprostol | Intervention Type: DRUG; Name: misoprostol+placebo; Assigned to Arm(s): misoprostol
D: Arm Label: 17 alfa hydroxy Progesterone caproate; Type: ACTIVE_COMPARATOR; Interventions: Drug: 17 alpha-hydroxy progesterone caproate | Arm Label: Micronized Progesterone; Type: ACTIVE_COMPARATOR; Interventions: Drug: micronized Progesterone | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Control | Intervention Type: DRUG; Name: 17 alpha-hydroxy progesterone caproate; Assigned to Arm(s): 17 alfa hydroxy Progesterone caproate | Intervention Type: DRUG; Name: micronized Progesterone; Assigned to Arm(s): Micronized Progesterone | Intervention Type: PROCEDURE; Name: Control; Assigned to Arm(s): Control

Answer: D