Preterm delivery, Maternal care for cervical incompetence, Maternal care for other abnormalities of cervix, Uterine Cervical Incompetence
Conditions
Interventions
Control group:
Progesterone
234 pregnant women with cervical measure below 30 mm and 234 pregnant women with cervical measure below 25 mm receive micronized progesterone, 200 mg per day to be administ
Drug
Device
E04.520.100
D05.750.900.850.900
Sponsors
UNIVERSIDADE ESTADUAL DE CAMPINAS
UNIVERSIDADE ESTADUAL DE CAMPINAS
Faculdade de Medicina de Jundiaí
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Hospital das Clínicas da Universidade Federal do Rio Grande do Sul
Hospital Dom Malan
Hospital Maternidade Vila Nova Cachoeirinha
Hospital Universitário Lauro Wanderley daUniversidade Federal da Paraíba
Instituto de Medicina Integral Prof. Fernandes Figueira IMIP
Instituto Fernandes Figueira
Eligibility
Sex/Gender
Female
Age
10 Years to No maximum
Inclusion criteria
Inclusion criteria: pregnant women between 18 weeks and 0 days and 22 weeks and 6 days of gestation with cervical length lower or equal 30 mm
Exclusion criteria
Exclusion criteria: Placenta previa diagnosed by US second or third quarter; greater than 1 cm cervical dilatation; painful uterine activity; active vaginal bleeding; cervical cerclage in the current pregnancy; cervical length <5 mm; Rupture of Membranes; severe liver disease; cholestasis occurred while current pregnancy; History or thromboembolic event during the pregnancy; monoamniotic Twin pregnancy; Multiple pregnancies with 3 or more fetuses; ultrasonographic signs of fetal-fetal transfusion; selective growth restriction diagnosis of type 2 or 3 Gratacós; Major fetal anomalies; Fetal death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal morbimortality of pregnant women using cervical pessary plus progesterone versus progesterone only. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gestational age at birth; mode of delivery; weight adequacy for gestational age; newborn vitality; sex of the newborn; preterm birth before 28, 32, 34 and 37 weeks of gestational age; days of neonatal intensive care unit admission; days of maternal admissions during pregnancy; screening, neonatal and maternal admissions costs; pessary use symptoms; spontaneous preterm birth and preterm rupture of membranes rates; imemdiate neonatal outcomes | — |
Countries
Brazil
Contacts
Public ContactRodolfo Pacagnella
UNIVERSIDADE ESTADUAL DE CAMPINAS
Outcome results
None listed