Cervical Ripening, Pregnancy, High-Risk
Conditions
Brief summary
The objective of this study is to compare pregnancy results which were used foley catheter or double-balloon catheter for cervical ripening among high-risk pregnant women.
Detailed description
This is a prospective observational study. The planned sample size was calculated as 109 patients per group with 80% power and 0.05 alpha error. The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score \<6, using a foley catheter or cook balloon for cervical ripening and high-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders). The exclusion criteria are being younger than 18 or over 40, communication problems, bishop score \>6, being at active labor, multifetal pregnancy, non-vertex presentation, scarred uterus (cesarean or myomectomy), fetal structural or chromosomal anomaly, non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage. The primary outcomes are the rate of bishop score \>6 after ripening, vaginal delivery rate and vaginal delivery within 24 hours of the initiation of ripening.
Interventions
mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon
Sponsors
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 40 * Singleton pregnancy * Vertex presentation * Bishop score \<6 * Using a Foley catheter or cook balloon for cervical ripening * High-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders)
Exclusion criteria
* Being younger than 18 or over 40 * Communication problems (foreign national) * Bishop score \>6 * Being at active labor * Multifetal pregnancy * Non-vertex presentation * Scarred uterus (cesarean or myomectomy) * Fetal structural or chromosomal anomaly * Non-reassuring fetal cardiotocography before cervical ripening * Regional anesthesia during the first stage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bishop score | at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously | bishop score \>6 is accepted as successful ripening. (max. 10, and the higher bishop score means better ripening has been occurred.) |
| vaginal delivery rate | until the patient gives birth | the difference in vaginal birth rate between groups |
| vaginal delivery within 24 hours | from the time of cervical ripening catheter insertion to the 24 hours | the difference in vaginal delivery within 24 hours rate between groups |
Countries
Turkey (Türkiye)
Outcome results
None listed