Double lumen foley catheter12/1/2023 ![]() ![]() The primary outcome will be time from foley bulb placement to time of delivery. Data collection of independent fetal variables will include gestational age and estimated fetal weight. As per usual protocol, additional cervical ripening and labor induction will proceed per managing obstetric team.ĭata collection will include the independent variables of maternal age, parity, BMI, race (Caucasian, African American, Hispanic, Asian, other), Bishop Score, use of magnesium and epidural use. At the time of manual removal or expulsion of the foley balloon, the patient's cervix will be checked by an experienced obstetric provider. If the patient's foley bulb does not spontaneously expel within the maximum allotted time, they will be manually removed at six or twelve hours. The use of concomitant low dose pitocin with the foley bulb will be at the discretion of the admitting obstetric team. In accordance with the standard of care, sterile saline will be placed in the intrauterine and vaginal balloon as tolerated by the patient for no more than a maximum of 80 cc in each balloon. Foley bulb will be inserted with or without speculum technique and with or without use of a stylet. A foley bulb will then be placed by a qualified obstetric provider. The randomization will be stratified based on parity (i.e., women who have had any prior vaginal delivery above 20 weeks gestation v. Patients will be randomized to the two groups using computer generated random numbers. Enrollment and randomization in the study will then occur. Consent will be obtained and witnessed from patients who elect to participate. Type of Study: This study will be a prospective, randomized clinical control trial with human subjects.Ī qualified obstetric provider will provide eligible women with details of the study, including study objectives and methods. Patients with a Bishop score ≤ 6 are thought to benefit from a cervical ripening agent and the participants will be randomized based on parity at this point. A digital cervical examination will be performed and a Bishop score assigned. Upon admission to Labor and Delivery, women will be assessed for eligibility by an obstetric physician. Medical indications for induction prior to 39 weeks include but are not limited to preeclampsia, oligohydramnios and growth restriction. As per the American College of Obstetricians and Gynecologists (ACOG) guidelines, all inductions performed prior to 39 weeks are medically indicated. Overview: All eligible patients with a singleton pregnancy at 37 weeks gestational age or greater who are presenting for a clinically/ medically indicated induction with an unfavorable cervical exam will be invited to participate. It is the hypothesis that the maximum cervical dilation and benefits of a double lumen foley catheter are achieved within the initial six hours after placement. Objective: To determine whether a double-lumen balloon catheter requires twelve hours in the cervical canal to achieve its maximal cervical dilation. ![]() Why Should I Register and Submit Results?.SUCH 40 POLY POUCHES IN A CORRUGATED CARTON BOX. Packaging Details : MEDICATED PAPER POUCH PACKING “STRAIGHT TYPE” PACKED IN A POLY POUCH OF 25 PIECES.Pay Mode Terms : L/C (Letter of Credit),T/T (Bank Transfer).Specifications of Foley Balloon Catheter: Non return valves help easy inflation & deflation of balloon.Biologically tested and ready for single use. ![]()
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