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Completed

NCT Number: NCT03928600

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

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

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Key information

Conditions

Labor, Induced Cervical Ripening

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar São João

Porto, 4100, Portugal

About this study

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-

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cervical Foley combined with Misoprostol

Combination Product

Placement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug

Dinoprostone 10mg insert OR

Drug

Application for 24h of Dinoprostone 10mg insert

Misoprostol

Drug

Application of vaginal misoprostol 25ug 4/4h until 150ug

Primary outcomes

  1. Time to delivery

    Time frame: 3 days

    Time to delivery

Secondary outcomes

  1. cesarean delivery rate

    Time frame: 3 days

    cesarean delivery rate

  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

    rate of delivery within 12 hours

  4. rate of delivery within 24 hours

    Time frame: 24 hours

    rate of delivery within 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

    indication for cesarean delivery

  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

Sponsors and collaborators

Lead sponsor

Centro Hospitalar De São João, E.P.E.

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2019
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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