Maternal care for cervical incompetence
Conditions
Interventions
Control Group
33 singleton pregnancies with a short cervix (less than 25mm) will receive vaginal progesterone, 200 mg per day, after study inclusion to 37 weeks of gestation.
TOTAL CONTROL GROUP 33
The Control Group will be sustained
the Study Group will be divided in Group before LC-CUSUM analysis, and Group After LC-CUSUM analysis.
TOTAL STUDY GROUP 95
TOTAL NUMBER OF INTERVENTION 128
Drug
Device
Sponsors
Universidade Federal de São Paulo - UNIFESP
Universidade Federal de São Paulo - UNIFESP
Eligibility
Sex/Gender
Female
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnant women between 18th to 24th week of gestation with cervical length lower or equal 25 mm
Exclusion criteria
Exclusion criteria: Cervical cerclage in current pregnancy; Greater than 1 cm cervical dilatation; Painful uterine activity; Labor; Rupture of membranes; Protrusion of membranes in the gynecological examination; Active vaginal bleeding; Placenta previa; Severe hepatic disease; Cholestasis during pregnancy; Thromboembolic event during pregnancy; multiple pregnancies; Major fetal abnormalities; Fetal death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of rate of preterm birth below 34 weeks, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum, determining the learning curve. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the increase of the gestational age at birth, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum. ;Evaluate the increase of the birthweigth, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum.;Evaluate the difference in individual performance of responsible researchers, regarding gestational age at inclusion, cervical length at inclusion and gestational age at delivery, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum.;Evaluate the Odds Ratio for preterm birth below 34 weeks, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum.;Evaluate the Kaplan-Meyer Survival analysis for preterm birth below 34 weeks, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum. | — |
Countries
Brazil
Contacts
Public ContactMarcelo França
Universidade Federal de São Paulo - UNIFESP
Outcome results
None listed