Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Women with a singleton pregnancy and a history of at least one previous preterm delivery before 34+0 weeks and/or a history of at least one previous cervical surgery
* 12+0 - 16+0 weeks of gestation at time of randomization
* only women with minimum age of 18 and capable of giving consent

Exclusion Criteria:

* major fetal abnormalities
* uterine malformation, placenta previa totalis
* Cerclage prior to randomization
* At randomisation: active vaginal bleeding and/or spontaneous rupture of membranes and/or painful regular uterine contractions
* silicone allergy
* current participation in other RCT
B: Inclusion Criteria:

* Singleton gestations
* Diagnosis of arrested PTL
* 18-50 years of age
* TVU CL ≤25mm at the time of randomization

Exclusion Criteria:

* Multiple gestations
* Rupture of membranes at the time of randomization
* Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
* Fetal death at the time of randomization
* Cerclage in situ at the time of randomization
* Pessary in situ at the time of randomization
* Vaginal bleeding at the time of randomization
* Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years
* Placenta previa and/or accreta
* Ballooning of membranes outside the cervix into the vaginal or TVU CL = 0mm at the time of randomization
* Painful and regular uterine contractions at the time of randomization
C: Inclusion Criteria:

* Minimal age of 18 years
* Episode of threatened preterm labour

Exclusion Criteria:

* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* Spontaneous rupture of membranes at the time of randomization
* Cervical cerclage in situ
* Active vaginal bleeding
* Placenta previa

Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).
D: Inclusion Criteria:

* Pregnant women with short cervix (=\< 25 mm) identified by use of routine transvaginal ultrasonography at 19-22 weeks of gestation.
* Single pregnancy
* Women older than 18 year-old
* Women sign informed consent according GCP and local legislation
* Gestational age at randomization between 20+1 and 23+6 weeks.

Exclusion Criteria:

* Major fetal abnormalities
* Major uterine abnormalities
* Placenta praevia during current pregnancy
* Vaginal bleeding or ruptured membranes in the moment of randomization
* Cervical cerclage in situ
* History of cone biopsy
* Allergic to peanuts
* Contraindication for Progesterone usage.
* Active treatment with Progesterone at randomization.
* History of 3 or more premature labor.
* If in the investigator's opinion, there are findings on physical examination, abnormalities in the results of clinical analyzes or other medical factors, social or psycho-social that could negatively influence.
* Women unable to give the informed consent

Answer: A