Outpatient Foley Cervix Priming

Outpatient Versus Inpatient Cervix Priming With Foley Catheter

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.

Study Overview

• Status: Completed
• Conditions: Outpatient Mechanical Cervix Priming
• Intervention / Treatment: Other: Outpatient Foley cervix priming

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Outpatient Foley cervix priming; Outpatient setting for cervix priming with Foley catheter
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospital de Santa Maria, Portugal
• Investigators: Principal Investigator: Catarina Policiano, MD, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte

Publications and helpful links

General Publications

• Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
• Policiano C, Pimenta M, Martins D, Clode N. Outpatient versus inpatient cervix priming with Foley catheter: A randomized trial. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:1-6. doi: 10.1016/j.ejogrb.2016.11.026. Epub 2016 Nov 27.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 25, 2016

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: SantaMariaPortugal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No