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

NCT ID: NCT03928600

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-02-29

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

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-

Conditions

Labor, Induced; Cervical Ripening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cervical Foley combined with Misoprostol

Intervention Type: COMBINATION_PRODUCT

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

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.

Group Type: PLACEBO_COMPARATOR

Dinoprostone 10mg insert OR

Intervention Type: DRUG

Application for 24h of Dinoprostone 10mg insert

Misoprostol

Intervention Type: DRUG

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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Dinoprostone 10mg insert OR

Application for 24h of Dinoprostone 10mg insert

Intervention Type: DRUG

Misoprostol

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

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role: lead

Responsible Party

Rita Polónia Valente

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rita P Valente, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar São João, Porto

Locations

Centro Hospitalar São João

Porto, , Portugal

Countries

Portugal

Other Identifiers

CES 171-17

Identifier Type: -

Identifier Source: org_study_id