Outpatient Foley Cervix Priming

Outpatient Versus Inpatient Cervix Priming With Foley Catheter

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02842879

Enrollment

120

Registered

2016-07-25

Start date

2014-01-31

Completion date

2015-12-31

Last updated

2016-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outpatient Mechanical Cervix Priming

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.

Interventions

OTHEROutpatient Foley cervix priming

Outpatient setting for cervix priming with Foley catheter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
variation of bishop score (difference between bishop score before and after application of foley catheter)	up to 24 months

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026