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Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03928600
Recruitment Status : Active, not recruiting
First Posted : April 26, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Rita Polónia Valente, Centro Hospitalar De São João, E.P.E.

Tracking Information
First Submitted Date  ICMJE March 4, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE February 1, 2018
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
Time to delivery [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • cesarean delivery rate [ Time Frame: 3 days ]
  • time to active labor [ Time Frame: 3 days ]
    defined as dilation of 6 cm or greater
  • rate of delivery within 12 hours [ Time Frame: 12 hours ]
  • rate of delivery within 24 hours [ Time Frame: 24 hours ]
  • mean of maternal length of stay [ Time Frame: average 3 days ]
    induction to discharge
  • indication for cesarean delivery [ Time Frame: 3 days ]
  • composite maternal morbidity outcome [ Time Frame: 6 weeks ]
    third- or fourth-degree perineal laceration, blood transfusion, chorioamnionitis, endometritis, wound infection, venous thromboembolism, hysterectomy, intensive care unit admission or death.
  • composite of neonatal morbidities [ Time Frame: 30 days ]
    SDR, neonatal sepsis, blood transfusion, encephalopathy hypoxic-ischemic, intraventricular hemorrhage of grade III/IV
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial
Official Title  ICMJE Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial
Brief Summary

Labor induction is a common pregnancy procedure worldwide. Both mechanical and pharmacologic agents are used for induction of labor. These agents reduce the incidence of cesarean delivery in women undergoing induction.

Opposite to old studies of cervical ripening, some recent studies have shown promise in reducing labor time and risk of cesarean delivery with combination methods. The effectiveness of this procedure is of major clinical importance and has a large impact in our quotidian practice.

The objective is to compare the effectiveness of a combined new method to current guidelines of our department

Detailed Description

We designed a randomized trial that will compare two groups: misoprostol-cervical Foley simultaneously and the current department guidelines (misoprostol alone/dinoprostone alone).

Inclusion criteria: full-term (≥ 37 weeks of gestation), singleton, vertex-

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Labor, Induced
  • Cervical Ripening
Intervention  ICMJE
  • Combination Product: Cervical Foley combined with Misoprostol
    Placement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug
  • Drug: Dinoprostone 10mg insert OR
    Application for 24h of Dinoprostone 10mg insert
  • Drug: Misoprostol
    Application of vaginal misoprostol 25ug 4/4h until 150ug
Study Arms  ICMJE
  • Experimental: Combined method induction group
    • 25 micrograms misoprostol vaginal applied placed along with cervical Foley (team will repeat misoprostol application each 4 hours till 6 doses of misoprostol)
    • After 4 hours of last misoprostol initiate oxytocin.
    • Cervical Foley will be removed after 12h of placement or when fails out.
    Intervention: Combination Product: Cervical Foley combined with Misoprostol
  • Placebo Comparator: Current department guidelines group
    • Following current department guidelines, as usual, with the method considered more suitable.
    • If they opted for vaginal misoprostol, team will insert 25micrograms, repeat application 4/4h, until 150micrograms, after last misoprostol, wait 4 hours before initiating oxytocin.
    • If option is vaginal dinoprostone the insert of 10mg is removed after 24h in place.
    Interventions:
    • Drug: Dinoprostone 10mg insert OR
    • Drug: Misoprostol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 25, 2019)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 29, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • full-term (≥ 37 weeks of gestation)
  • singleton
  • vertex-presenting gestations
  • with no contraindication to vaginal delivery
  • intact membranes
  • Bishop score < 7 and cervical dilation ≤2 cm

Exclusion Criteria:

  • contraindication for misoprostol
  • history of previous caesarean
  • rupture of membranes,
  • fetal or maternal morbidities (fetal major abnormalities, FIGO definition of pathological CTG, HELLP syndrome, preeclampsia or hypertension with severe features, fetal growth restriction)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928600
Other Study ID Numbers  ICMJE CES 171-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Rita Polónia Valente, Centro Hospitalar De São João, E.P.E.
Study Sponsor  ICMJE Centro Hospitalar De São João, E.P.E.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rita P Valente, MD Centro Hospitalar São João, Porto
PRS Account Centro Hospitalar De São João, E.P.E.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP