Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Device: Transcervical Foley catheter
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaginal misoprostol and intracervical Foley catheter<br>participants will receive misoprostol by the same dose and method. Transcervical Foley catheter (size 16F, with 30ml balloon capacity) will be passed. The catheter will deﬂated, removed and cervix re-assessed if no spontaneous expulsion occurred at 12 hours post- insertion. A new catheter will be passed for another 12 hours, if the Bishop score is less than 8 this will be considered as failure of induction. | Device: Transcervical Foley catheter<br>* combined methods of induction of labor Floey Catheter with misoprstol<br>Drug: Misoprostol<br>* Misoprstol inserted vaginally for induction of labor<br>|
| Active Comparator: vaginal misoprostol<br>Misoprostol group; participants will receive 50 μg intravaginal in the posterior vaginal fornix, 25 μg will be given every 4 hours for another two doses, if a satisfactory Bishop score of 8 not reached, patient will take an overnight rest and she will continue induction by the same doses on the next day-provided that there is no ROMs- (this is according to Ain Shams University Protocol) The maximum dose of Misoprostol is 200 μg. Oxytocin infusion will not started until 6 hours after the last dose or if there is no adequate contractions obtained. | Drug: Misoprostol<br>* Misoprstol inserted vaginally for induction of labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction delivery time | time elapsed from start of induction till delivery of the baby | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| misoprstol dose | total misoprstol needed in each group | 24 hours | 
| induction active stage time | time elapsed from induction of labor till reaching 6 cm cervical dialtation | 24 hours | 
| Mode of delivery | mode od delivery either vaginal or Caesarian Section | 48 hours | 
| Maternal Pyrexia | fever (Temp > 37.8 ) any time during labor | 48 hours | 
| hypersystole | one uterine contraction with duration of more than 90 sec. | 48 hours | 
| Tachysystole | Tachysystole as 5 or more contraction in 10 minutes for two consecutive 10 minutes without FHR abnormalities. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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misoprostol , intracervical Foley catheter , induction of labor , term pregnancy.