Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth
Brief Summary: Cervical cerclage was devised in the 1950's for women with prior early preterm births (PTB) who developed a dilated cervix detected by manual exam in the second trimester. In contemporary practice, there are three possible indications for cerclage. History-indicated cerclage (HIC) is defined as a cerclage placed usually between 12-15 weeks based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. Ultrasound-indicated cerclage (UIC) is defined as a cerclage placed usually between 16-23 weeks for transvaginal ultrasound (TVU) cervical length (CL) \< 25mm in a woman with a prior spontaneous PTB. Physical-exam indicated is defined as a cerclage placed usually between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected on physical (manual) examination.

Randomized trials and meta-analysis of these have shown that UIC is associated with significant reduction in PTB and improved neonatal outcome, whereas evidence of efficacy for history-indicated cerclage and physical exam-indicated cerclage is limited. In the United States, the national data shows that the rate of cerclage has decreased in the last few years. The indications of placement of cerclage have recently changed, and so it is important to evaluate how many women are getting this procedure. With the recent completion of clinical trials, it is plausible that obstetricians and perinatologists may have become more selective in terms of the best candidates for cerclage.

The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB as adjuctive therapy in women with UIC


Options:
A: Arm Label: Vaginal progesterone only; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Cervical cerclage plus vaginal progesterone; Type: EXPERIMENTAL; Interventions: Procedure: Cerclage | Intervention Type: PROCEDURE; Name: Cerclage; Assigned to Arm(s): Cervical cerclage plus vaginal progesterone
B: Arm Label: 17P plus Omega-3 Supplement; Type: ACTIVE_COMPARATOR; Interventions: Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement | Arm Label: 17P plus Placebo Supplement; Type: PLACEBO_COMPARATOR; Interventions: Drug: 17 alpha-hydroxy progesterone caproate and Placebo supplement | Intervention Type: DRUG; Name: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement; Assigned to Arm(s): 17P plus Omega-3 Supplement | Intervention Type: DRUG; Name: 17 alpha-hydroxy progesterone caproate and Placebo supplement; Assigned to Arm(s): 17P plus Placebo Supplement
C: Arm Label: Cervical Pessary; Type: EXPERIMENTAL; Interventions: Device: Cervical pessary | Arm Label: No intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Cervical pessary; Assigned to Arm(s): Cervical Pessary
D: Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: indomethacin and antibiotics; Type: EXPERIMENTAL; Interventions: Drug: Indomethacin and antibiotics (cefazolin or clindamycin) | Intervention Type: DRUG; Name: Indomethacin and antibiotics (cefazolin or clindamycin); Assigned to Arm(s): indomethacin and antibiotics

Answer: C