Outpatient Foley Cervix Priming

Not Applicable

Completed

• Conditions: Outpatient Mechanical Cervix Priming
• Interventions: Other: Outpatient Foley cervix priming

• Registration Number: NCT02842879
• Lead Sponsor: Hospital de Santa Maria, Portugal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-20
• Study First Posted: 2016-07-25
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient Foley cervix priming	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
mode of delivery	up to 24 months
maternal pain evaluated by visual analog scale for pain	up to 24 months
induction-to-delivery time	up to 24 months