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NCT07935681
Foley Catheter vs. Foley + Extra-amniotic Saline Infusion for Labor Induction at 41 Weeks and Beyond
Conditions: Labor Induction, Post-term Pregnancy, Cervical Ripening, Nulliparity
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: Ankara City Hospital Bilkent
Location: Bilkent City Hospital Ankara ÇANKAYA
Summary
This study is a prospective, randomized controlled trial conducted at Ankara Bilkent City Hospital to compare two mechanical methods for labor induction in post-term pregnancies. The research evaluates the efficacy and safety of a Foley catheter alone versus a Foley catheter combined with extra-amniotic saline infusion (EASI). The study specifically targets primiparous women with a gestational age greater than or equal to 41+0 weeks and an unfavorable cervix, defined as an initial Bishop score less than or equal to 6. The primary objective is to determine the change in the Bishop score within the first 6 hours to identify which method more effectively promotes cervical ripening and successful labor induction.
Eligibility Criteria
Inclusion Criteria:
Primiparous women (First-time mothers).
Gestational age greater than or equal to 41+0 weeks.
Singleton pregnancy in cephalic presentation.
Unfavorable cervix, defined as a Bishop score less than or equal to 6.
Reactive Non-Stress Test (NST) and a biophysical profile score greater than or equal to 8/10.
Aged greater than or equal to 18 years.
Willingness to provide written informed consent. -
Exclusion Criteria:
Multiple pregnancies (e.g., twins, triplets).
Previous uterine surgery (e.g., prior Cesarean section or myomectomy).
Premature Rupture of Membranes (PROM).
Presence of placenta previa or vasa previa.
Fetal growth restriction (IUGR).
Active genital herpes infection.
Known hypersensitivity to the materials used (e.g., latex allergy if applicable).
Serious maternal systemic diseases (e.g., severe heart disease, uncontrolled diabetes, or preeclampsia).
Fetal anomalies or non-reassuring fetal heart rate patterns.
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Source: ClinicalTrials.gov (NCT07935681). StuddyBuddy aggregates publicly available trial information.