Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

Vaginal Misoprostol With Intracervical Foley Catheter Versus Vaginal Misoprostol Alone in Induction of Labor at Term Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682718
• Other study ID #: ase36278
• Status: Completed
• Phase: Phase 4
• 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
• 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

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