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

Centro Hospitalar De São João, E.P.E.

Status: Completed

Conditions: Labor, Induced; Cervical Ripening

Treatments: Drug: Misoprostol; Combination Product: Cervical Foley combined with Misoprostol; Drug: Dinoprostone 10mg insert OR

Study type: Interventional

Funder types: Other

Identifiers

NCT03928600

CES 171-17

Details and patient eligibility

About

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

Full 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-

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups, including a placebo group

Combined method induction group

Experimental group

Description:

* 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.

Treatment:

Combination Product: Cervical Foley combined with Misoprostol

Current department guidelines group

Placebo Comparator group

Description:

* 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.

Treatment:

Drug: Misoprostol

Drug: Dinoprostone 10mg insert OR