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

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ClinicalTrials.gov Identifier: NCT03928600
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Rita Polónia Valente, Centro Hospitalar De São João, E.P.E.

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 Intervention/treatment Phase
Labor, Induced Cervical Ripening Combination Product: Cervical Foley combined with Misoprostol Drug: Dinoprostone 10mg insert OR Drug: Misoprostol Not Applicable

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-


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Study Type : Interventional  (Clinical Trial)
Estimated 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 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Time to delivery [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. cesarean delivery rate [ Time Frame: 3 days ]
  2. time to active labor [ Time Frame: 3 days ]
    defined as dilation of 6 cm or greater

  3. rate of delivery within 12 hours [ Time Frame: 12 hours ]
  4. rate of delivery within 24 hours [ Time Frame: 24 hours ]
  5. mean of maternal length of stay [ Time Frame: average 3 days ]
    induction to discharge

  6. indication for cesarean delivery [ Time Frame: 3 days ]
  7. 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.

  8. composite of neonatal morbidities [ Time Frame: 30 days ]
    SDR, neonatal sepsis, blood transfusion, encephalopathy hypoxic-ischemic, intraventricular hemorrhage of grade III/IV



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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)

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): NCT03928600


Contacts
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Contact: Rita P Valente, MD 225512382 ritapoloniavalente@gmail.com

Locations
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Portugal
Centro Hospitalar São João Recruiting
Porto, Portugal, 4100
Contact: Rita P Valente, MD         
Sponsors and Collaborators
Centro Hospitalar De São João, E.P.E.
Investigators
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Principal Investigator: Rita P Valente, MD Centro Hospitalar São João, Porto

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Responsible Party: Rita Polónia Valente, Principal Investigator, 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: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Rita Polónia Valente, Centro Hospitalar De São João, E.P.E.:
induction of labor
cervical ripening
combined methods

Additional relevant MeSH terms:
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Misoprostol
Dinoprostone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics