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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03682718
Other study ID # ase36278
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 1, 2018
Est. completion date February 1, 2019

Study information

Verified date January 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.


Description:

Cervical status is a good predictor of the likelihood of vaginal delivery when labor is induced. Any induction method is likely to be effective in a woman with a favorable cervix, whereas no method is highly successful when performed in a woman with a cervix that is unfavorable. The use of a balloon catheter as induction method was first described in 1862 by Trainer. The goal of the catheter was to ripen the cervix through direct mechanical dilatation of the cervical canal and indirectly by increasing endogenous prostaglandin secretion. Alternatively, Prostaglandins are one of the key players in cervical ripening by a number of different mechanisms. The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date February 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: Singleton pregnancy Gestational age = 37 weeks (calculated from reliable menstrual dates and/or late first trimester or early second trimester ultrasound) Modified Bishop Score = 5 Valid indication for induction of labor Intact fetal membranes Normal fetal non-stress test cervical dilation less than or equal to 2cm vertex presentation Exclusion Criteria: Any contraindication for vaginal delivery (e.g. placenta Previa, accrete ) Any contraindication for induction of labor (e.g. fetal malpersentation, prior uterine surgery) Active labor Antepartum hemorrhage Eclampsia Patients with hemolysis, elevated liver enzymes and low platelets Suspected chorioamnitis Intrauterine growth retardation Multiple gestation Non-reassuring fetal heart rate Continuous contractions more than 3 times in 10 minutes at onset of induction of labor Intrauterine fetal demise Any contraindication for use of misoprostol (e.g. bronchial asthma, drug allergy, History of glaucoma) Any contraindication for use of Foley catheter (already ripped cervix) Rupture of membranes Not consenting

Study Design


Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn

Intervention

Device:
Transcervical Foley catheter
combined methods of induction of labor Floey Catheter with misoprstol
Drug:
Misoprostol
Misoprstol inserted vaginally for induction of labor

Locations

Country Name City State
Egypt Ahmed Abass Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Neonatal Apgar score Neonatal Apgar score 1 min after delivery
Other Neonatal Apgar score Neonatal Apgar score 5 min after delivery
Other Neonatal birth weight Neonatal birth weight 10 min after delivery
Other neonatal ICU admission Number of neonates in need for ICU admission 2 hours after delivery
Primary induction delivery time time elapsed from start of induction till delivery of the baby 48 hours
Secondary misoprstol dose total misoprstol needed in each group 24 hours
Secondary induction active stage time time elapsed from induction of labor till reaching 6 cm cervical dialtation 24 hours
Secondary Mode of delivery mode od delivery either vaginal or Caesarian Section 48 hours
Secondary Maternal Pyrexia fever (Temp > 37.8 ) any time during labor 48 hours
Secondary hypersystole one uterine contraction with duration of more than 90 sec. 48 hours
Secondary Tachysystole Tachysystole as 5 or more contraction in 10 minutes for two consecutive 10 minutes without FHR abnormalities. 48 hours
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