## Protocol Section
### Identification Module
**NCT ID:** NCT02842879

**Brief Title:** Outpatient Foley Cervix Priming

**Official Title:** Outpatient Versus Inpatient Cervix Priming With Foley Catheter

#### Organization Study ID Info
**ID:** SantaMariaPortugal
#### Organization
**Class:** OTHER
**Full Name:** Hospital de Santa Maria, Portugal
### Status Module
#### Completion Date
**Date:** 2015-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-07-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-07-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-12

**Type:** ACTUAL

#### Start Date
**Date:** 2014-01

**Status Verified Date:** 2016-07

#### Study First Post Date
**Date:** 2016-07-25
**Type:** ESTIMATED
**Study First Submit Date:** 2016-07-15
**Study First Submit QC Date:** 2016-07-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital de Santa Maria, Portugal

#### Responsible Party

**Investigator Affiliation:** Hospital de Santa Maria, Portugal

**Investigator Full Name:** Catarina Policiano

**Investigator Title:** Dr. Catarina Policiano

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Outpatient Mechanical Cervix Priming

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Outpatient Foley cervix priming

**Label:** Outpatient Foley cervix priming

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Label:** Inpatient Foley cervix priming

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Outpatient Foley cervix priming

**Description:** Outpatient setting for cervix priming with Foley catheter

**Name:** Outpatient Foley cervix priming

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** variation of bishop score (difference between bishop score before and after application of foley catheter)

**Time Frame:** up to 24 months

#### Secondary Outcomes

**Measure:** mode of delivery

**Time Frame:** up to 24 months

**Measure:** induction-to-delivery time

**Time Frame:** up to 24 months

**Measure:** maternal pain evaluated by visual analog scale for pain

**Time Frame:** up to 24 months

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 15 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Hospital de Santa Maria, Centro Hospitalar Lisboa Norte

**Name:** Catarina Policiano, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** YES

### References Module

#### References

**Citation:** 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.

**PMID:** 32852803

**Citation:** 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.

**PMID:** 27923165

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M10488

- Name: Iodine

- Relevance: LOW

- As Found: Unknown

- ID: M229695

- Name: Cadexomer iodine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
