Outpatient Foley Cervix Priming

NCT02842879 | Completed

• 1 other identifier: SantaMariaPortugal
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Outpatient Mechanical Cervix Priming

Outcome Measures

Primary Outcomes (1)

• variation of bishop score (difference between bishop score before and after application of foley catheter)

  up to 24 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Outpatient Foley cervix priming

EXPERIMENTAL

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

Inpatient Foley cervix priming

NO INTERVENTION

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.

Interventions

Outpatient Foley cervix priming OTHER

Outpatient setting for cervix priming with Foley catheter

Outpatient Foley cervix priming

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Santa Maria, Portugal: lead

Related Publications (2)

• 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 DERIVED

• 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

Study Officials

• Catarina Policiano, MD

  Hospital de Santa Maria, Centro Hospitalar Lisboa Norte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Catarina Policiano

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 25, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 25, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share