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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03928600

Recruitment Status Active, not recruiting

First Posted April 26, 2019

Last update posted March 10, 2020

Study Description

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

  • Condition or Disease:Labor, Induced
    Cervical Ripening
  • Intervention/Treatment: Combination Product: Cervical Foley combined with Misoprostol
    Drug: Dinoprostone 10mg insert OR
    Drug: Misoprostol
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 140 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial
  • Actual Study Start Date: February 2018
  • Estimated Primary Completion Date: January 2020
  • Actual Study Completion Date: February 2020
Arms and interventions
Arm Intervention/treatment
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.
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
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.
Drug: Dinoprostone 10mg insert OR
Application for 24h of Dinoprostone 10mg insert

Drug: Misoprostol
Application of vaginal misoprostol 25ug 4/4h until 150ug
Outcome Measures
  • Primary Outcome Measures: 1. Time to delivery [ Time Frame: 3 days ]
  • Secondary Outcome Measures: 1. 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.
  • 2. composite of neonatal morbidities [ Time Frame: 30 days ]
    SDR, neonatal sepsis, blood transfusion, encephalopathy hypoxic-ischemic, intraventricular hemorrhage of grade III/IV
  • 3. cesarean delivery rate [ Time Frame: 3 days ]
  • 4. time to active labor [ Time Frame: 3 days ]
    defined as dilation of 6 cm or greater
  • 5. rate of delivery within 12 hours [ Time Frame: 12 hours ]
  • 6. rate of delivery within 24 hours [ Time Frame: 24 hours ]
  • 7. mean of maternal length of stay [ Time Frame: average 3 days ]
    induction to discharge
  • 8. indication for cesarean delivery [ Time Frame: 3 days ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

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)

Contacts and Locations
Contacts
Locations

Portugal
Centro Hospitalar São João
Porto

Sponsors and Collaborators

Centro Hospitalar De São João, E.P.E.

Investigators

Principal Investigator: Rita P Valente, MD Centro Hospitalar São João, Porto

More Information
  • Responsible Party: Centro Hospitalar De São João, E.P.E.
  • ClinicalTrials.gov Identifier: NCT03928600 History of Changes
  • Other Study ID Numbers: CES 171-17
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: March 10, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • 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.: Yes
  • Keywords provided by Centro Hospitalar De São João, E.P.E.: induction of labor
    cervical ripening
    combined methods