Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of History-indicated Early Treatment With Cervical Pessary Versus Expectant Management Treatment With Rescue Cerclage in Cases With Cervical Shortening in Singleton Pregnancies at High-risk for sPTB on Children's Long-term Outcome
Brief Summary: Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well.

The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity \< 34 week of gestation (WoG).

The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.


Options:
A: Arm Label: Cervical Pessary-Group; Type: EXPERIMENTAL; Interventions: Device: cervical pessary | Arm Label: Control-Group; Type: OTHER; Interventions: Other: Control-Group | Intervention Type: DEVICE; Name: cervical pessary; Assigned to Arm(s): Cervical Pessary-Group | Intervention Type: OTHER; Name: Control-Group; Assigned to Arm(s): Control-Group
B: Arm Label: Pessary; Type: EXPERIMENTAL; Interventions: Device: arabin pessary | Arm Label: No Pessary; Type: ACTIVE_COMPARATOR; Interventions: Device: no pessary | Intervention Type: DEVICE; Name: arabin pessary; Assigned to Arm(s): Pessary | Intervention Type: DEVICE; Name: no pessary; Assigned to Arm(s): No Pessary
C: Arm Label: Expectant Management; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Placement of cervical pessary since 23 weeks until 37 weeks; Type: EXPERIMENTAL; Interventions: Device: Device: Silicon ring (Arabin Pessary) | Intervention Type: DEVICE; Name: Device: Silicon ring (Arabin Pessary); Assigned to Arm(s): Placement of cervical pessary since 23 weeks until 37 weeks
D: Arm Label: Vaginal micronized progesterone; Type: EXPERIMENTAL; Interventions: Drug: Vaginal micronized progesterone | Arm Label: Cervical pessary; Type: ACTIVE_COMPARATOR; Interventions: Device: Cervical pessary | Intervention Type: DRUG; Name: Vaginal micronized progesterone; Assigned to Arm(s): Vaginal micronized progesterone | Intervention Type: DEVICE; Name: Cervical pessary; Assigned to Arm(s): Cervical pessary

Answer: A