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

Cervical Ripening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928600
• Other study ID #: CES 171-17
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: January 2023
• Source: Centro Hospitalar De São João, E.P.E.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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-

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 29, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cervical Ripening
• Labor, Induced

Intervention

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

Drug:
• Dinoprostone 10mg insert OR
Application for 24h of Dinoprostone 10mg insert
• Misoprostol
Application of vaginal misoprostol 25ug 4/4h until 150ug

Locations

Country	Name	City	State
Portugal	Centro Hospitalar São João	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar De São João, E.P.E.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to delivery	Time to delivery	3 days
Secondary	cesarean delivery rate	cesarean delivery rate	3 days
Secondary	time to active labor	defined as dilation of 6 cm or greater	3 days
Secondary	rate of delivery within 12 hours	rate of delivery within 12 hours	12 hours
Secondary	rate of delivery within 24 hours	rate of delivery within 24 hours	24 hours
Secondary	mean of maternal length of stay	induction to discharge	average 3 days
Secondary	indication for cesarean delivery	indication for cesarean delivery	3 days
Secondary	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
Secondary	composite of neonatal morbidities	SDR, neonatal sepsis, blood transfusion, encephalopathy hypoxic-ischemic, intraventricular hemorrhage of grade III/IV	30 days