Please select the eligibility criteria that correspond 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: Inclusion Criteria:

1. Women aged: 20-38 years old.
2. Single living fetus.
3. The patient does not have history of preterm labor (before 37 weeks of gestation)
4. No history of cervical or uterine anomalies.

Exclusion Criteria:

1. Congenital anomalies in the fetus discovered during the follow up.
2. History of spontaneous preterm births.
3. Evidence of imminent delivery, or uterine contractions.
4. Evidence of rupture of membranes, or intra amniotic infection.
5. Intra uterine fetal death.
6. Uterine or cervical anomalies.
B: Inclusion Criteria:

* Documented history of previous singleton spontaneous birth
* Singleton pregnancy
* Gestational age at randomization between 16 and 22 weeks

Exclusion Criteria:

* Major fetal anomaly or demise
* Regular intake of fish oil supplements
* Daily use of nonsteroidal anti-inflammatory agents
* Allergy to fish or fish products
* Gluten intolerant
* Heparin use or known thrombophilia
* Hemophilia
* Planned termination
* Current hypertension or current use of antihypertensive medications
* Type D, F or R diabetes
* Maternal medical complications
* Current or planned cerclage
* Illicit drug or alcohol abuse during current pregnancy
* Delivery at a non-Network hospital
* Participation in another pregnancy intervention study
* Participation in this trial in a previous pregnancy
C: Inclusion Criteria:

* 18-50 years of age
* Singleton gestations
* Women with prior preterm birth and with short cervical length (TVU CL \<25 mm) who underwent UIC

Exclusion Criteria:

* multiple gestation
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina
* Painful regular uterine contractions
* Labor
* Placenta previa
D: Inclusion Criteria:

* GA 16+0 to 23+6 weeks
* Singleton gestation
* Presence of cervical dilation as diagnosed on digital examination
* Intact membranes

Exclusion Criteria:

* Age \<18 years
* Allergy to NSAIDs
* Renal disease
* Allergy to penicillins AND clindamycin
* Currently on antibiotics or indomethacin for any reason
* HIV positive
* Pregnancies complicated by fetal congenital anomalies
* Preterm premature rupture of membranes
* Fever of 100.4 degrees Fahrenheit or higher
* Any patient having received a therapeutic cerclage during the current pregnancy

Answer: C