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

NCT03928600 | Completed

• 1 other identifier: CES 171-17
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Labor, Induced; Cervical Ripening

Keywords

induction of labor; cervical ripening; combined methods

Outcome Measures

Primary Outcomes (1)

• Time to delivery

  Time to delivery

  3 days

Secondary Outcomes (8)

• cesarean delivery rate

  3 days

• time to active labor

  3 days

• rate of delivery within 12 hours

  12 hours

• rate of delivery within 24 hours

  24 hours

• mean of maternal length of stay

  average 3 days

Study Arms (2)

Combined method induction group

EXPERIMENTAL

* 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

Current department guidelines group

PLACEBO COMPARATOR

* 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; Drug: Misoprostol

Interventions

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

Combined method induction group

Dinoprostone 10mg insert OR DRUG

Application for 24h of Dinoprostone 10mg insert

Current department guidelines group

Misoprostol DRUG

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

Current department guidelines group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centro Hospitalar De São João, E.P.E.: lead

Study Sites (1)

Centro Hospitalar São João

Porto, 4100, Portugal

Location

MeSH Terms

Interventions

Misoprostol; Dinoprostone; Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E; Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Rita P Valente, MD

  Centro Hospitalar São João, Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: April 26, 2019
• Study Start: February 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: February 29, 2020
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: no ending
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

PT (1)