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Outpatient Foley Cervix Priming

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ClinicalTrials.gov Identifier: NCT02842879
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Catarina Policiano, 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.


Condition or disease Intervention/treatment Phase
Outpatient Mechanical Cervix Priming Other: Outpatient Foley cervix priming Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Outpatient Versus Inpatient Cervix Priming With Foley Catheter
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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.



Primary Outcome Measures :
  1. variation of bishop score (difference between bishop score before and after application of foley catheter) [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. mode of delivery [ Time Frame: up to 24 months ]
  2. induction-to-delivery time [ Time Frame: up to 24 months ]
  3. maternal pain evaluated by visual analog scale for pain [ Time Frame: up to 24 months ]


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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842879


Sponsors and Collaborators
Hospital de Santa Maria, Portugal
Investigators
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Principal Investigator: Catarina Policiano, MD Hospital de Santa Maria, Centro Hospitalar Lisboa Norte
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Catarina Policiano, Dr. Catarina Policiano, Hospital de Santa Maria, Portugal
ClinicalTrials.gov Identifier: NCT02842879    
Other Study ID Numbers: SantaMariaPortugal
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes