Outpatient Foley Cervix Priming

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Outpatient Versus Inpatient Cervix Priming With Foley Catheter

Conditions
-----------------
Outpatient Mechanical Cervix Priming

Intervention / Treatment
-----------------
* Other: Outpatient Foley cervix priming


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient Foley cervix priming<br>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. | Other: Outpatient Foley cervix priming<br>* Outpatient setting for cervix priming with Foley catheter<br>|
| No Intervention: Inpatient Foley cervix priming<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of bishop score (difference between bishop score before and after application of foley catheter) |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mode of delivery |  | up to 24 months | 
| induction-to-delivery time |  | up to 24 months | 
| maternal pain evaluated by visual analog scale for pain |  | up to 24 months |