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

Study Overview

• Status: Completed
• Conditions: Labor, Induced; Cervical Ripening
• Intervention / Treatment: Combination product: Cervical Foley combined with Misoprostol; Drug: Dinoprostone 10mg insert OR; Drug: Misoprostol

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: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4100
    • Centro Hospitalar Sao Joao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to delivery	Time to delivery	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cesarean delivery rate	cesarean delivery rate	3 days
time to active labor	defined as dilation of 6 cm or greater	3 days
rate of delivery within 12 hours	rate of delivery within 12 hours	12 hours
rate of delivery within 24 hours	rate of delivery within 24 hours	24 hours
mean of maternal length of stay	induction to discharge	average 3 days
indication for cesarean delivery	indication for cesarean delivery	3 days
composite maternal morbidity outcome	third- or fourth-degree perineal laceration, blood transfusion, chorioamnionitis, endometritis, wound infection, venous thromboembolism, hysterectomy, intensive care unit admission or death.	6 weeks
composite of neonatal morbidities	SDR, neonatal sepsis, blood transfusion, encephalopathy hypoxic-ischemic, intraventricular hemorrhage of grade III/IV	30 days

Collaborators and Investigators

• Sponsor: Centro Hospitalar De São João, E.P.E.
• Investigators: Principal Investigator: Rita P Valente, MD, Centro Hospitalar São João, Porto

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: cervical ripening; induction of labor; combined methods
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Dinoprostone
• Other Study ID Numbers: CES 171-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study Protocol, Informed Consent Form, Statistical Analysis Plan
• IPD Sharing Time Frame: no ending
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• 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