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

Study Overview
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Brief Summary
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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
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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-

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

Conditions
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Labor, Induced, Cervical Ripening

Intervention / Treatment
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* Combination Product: Cervical Foley combined with Misoprostol
* Drug: Dinoprostone 10mg insert OR
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined method induction group<br>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<br>* Placement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug<br>|
| Placebo Comparator: Current department guidelines group<br>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<br>* Application for 24h of Dinoprostone 10mg insert<br>Drug: Misoprostol<br>* Application of vaginal misoprostol 25ug 4/4h until 150ug<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction of labor, cervical ripening, combined methods