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.
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.
Study Type
OBSERVATIONAL
Enrollment
222
mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon
University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
Ankara, Turkey (Türkiye)
bishop score
bishop score \>6 is accepted as successful ripening. (max. 10, and the higher bishop score means better ripening has been occurred.)
Time frame: at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously
vaginal delivery rate
the difference in vaginal birth rate between groups
Time frame: until the patient gives birth
vaginal delivery within 24 hours
the difference in vaginal delivery within 24 hours rate between groups
Time frame: from the time of cervical ripening catheter insertion to the 24 hours
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