Outpatient Foley Cervix Priming

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Outpatient Mechanical Cervix Priming

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Outpatient Foley cervix priming

Intervention Type OTHER

Outpatient setting for cervix priming with Foley catheter

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Outpatient Foley cervix priming

Outpatient setting for cervix priming with Foley catheter

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes