Outpatient Foley Cervix Priming

Hospital de Santa Maria, Portugal

Status: Completed

Conditions: Outpatient Mechanical Cervix Priming

Treatments: Other: Outpatient Foley cervix priming

Study type: Interventional

Funder types: Other

Identifiers

NCT02842879

SantaMariaPortugal

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Outpatient Foley cervix priming

Experimental group

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.

Treatment:

Other: Outpatient Foley cervix priming

Inpatient Foley cervix priming

No Intervention group

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.