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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03928600
Other study ID # CES 171-17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
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Recruiting NCT01156948 - Misoprostol For Nulliparous Women Before Hysteroscopy Phase 3
Completed NCT00504465 - Combined Agent Randomized Trial of Induction of Labor N/A
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Not yet recruiting NCT00815542 - Induction of Labor in Oligohydramnios Phase 3
Completed NCT01170819 - Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening. Phase 4
Completed NCT00442663 - Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction N/A