Outpatient Foley Cervix Priming

Overview

The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score < 6, gestational age > 41 weeks or medical indication for induction of labor. Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter. The primary outcome will be to compare the variation of Bishop score (difference between Bishop score before and after application of Foley catheter) between outpatient and inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and maternal pain.

Full Title of Study: “Outpatient Versus Inpatient Cervix Priming With Foley Catheter”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Interventions

  • Other: Outpatient Foley cervix priming
    • Outpatient setting for cervix priming with Foley catheter

Arms, Groups and Cohorts

  • Experimental: Outpatient Foley cervix priming
    • Patients randomized to outpatient cervix priming will have the insertion of the catheter in the same conditions defined by the Department protocol for inpatient cervix priming. They will be discharged after a reassuring cardiotocogram following the introduction of the Foley catheter. When discharged, the patients will be instructed to apply manual traction to the catheter every 6 hours and they will be given a written document with all the information that should bring them back to hospital.
  • No Intervention: Inpatient Foley cervix priming
    • The introduction of a deflated catheter (Foley catheter nº 16F) through the outer cervix orifice is preceded by iodine disinfection of the cervix. The intracervical catheter is distended with 40mL of a saline solution. The end of the catheter is taped to the medial portion of the thigh and manual traction is applied to the catheter every 6 hours. If it is not spontaneously extruded it is removed after 24h. Cervix priming occurs in an inpatient setting.

Clinical Trial Outcome Measures

Primary Measures

  • variation of bishop score (difference between bishop score before and after application of foley catheter)
    • Time Frame: up to 24 months

Secondary Measures

  • mode of delivery
    • Time Frame: up to 24 months
  • induction-to-delivery time
    • Time Frame: up to 24 months
  • maternal pain evaluated by visual analog scale for pain
    • Time Frame: up to 24 months

Participating in This Clinical Trial

Inclusion Criteria

  • women with a single fetus in cephalic presentation – Bishop score < 6 – Gestational age > 41 weeks or medical indication for induction of labor submitted to cervix priming with Foley catheter Exclusion Criteria:

  • women with a fetus in noncephalic presentation – an indication for elective cesarean delivery – spontaneous labor – hydramnios (amniotic fluid index ≥ 25) – nonreassuring cardiotocogram – multiple pregnancy – rupture of membranes – active vaginal bleeding – indication for prophylaxis of Streptococcus group B infection – HIV infection – cervical injury – previous cesarean section with recurrent indication

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital de Santa Maria, Portugal
  • Provider of Information About this Clinical Study
    • Principal Investigator: Catarina Policiano, Dr. Catarina Policiano – Hospital de Santa Maria, Portugal
  • Overall Official(s)
    • Catarina Policiano, MD, Principal Investigator, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte

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