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CTRI Number  CTRI/2021/01/030348 [Registered on: 08/01/2021] Trial Registered Prospectively
Last Modified On: 07/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing a drug causing labor pains when given orally vs vaginally in pregnant women 
Scientific Title of Study   A Randomised Controlled Trial Comparing Transcervical Foleys Catheter With Oral V/S Vaginal Misoprostol In Pregnant Women At Term For Induction Of Labor 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kanan Rambani 
Designation  Junior Resident  
Affiliation  DR.RPGMC, KANGRA AT TANDA HIMACHAL PRADESH 
Address  Department of obstetrics and Gynecology DR.RPGMC KANGRA AT TANDA

Kangra
HIMACHAL PRADESH
176001
India 
Phone  7986488185  
Fax    
Email  Kananrambani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kanan Rambani 
Designation  Junior Resident  
Affiliation  DR.RPGMC, KANGRA AT TANDA HIMACHAL PRADESH 
Address  Department of obstetrics and Gynecology DR.RPGMC KANGRA AT TANDA

Kangra
HIMACHAL PRADESH
176001
India 
Phone  7986488185  
Fax    
Email  Kananrambani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr CD Sharma 
Designation  Assistant Professor 
Affiliation  DR.RPGMC, KANGRA AT TANDA HIMACHAL PRADESH 
Address  Department of obstetrics and Gynecology DR.RPGMC KANGRA AT TANDA

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9816326544  
Fax    
Email  cdsharma2006@gmail.com  
 
Source of Monetary or Material Support  
DR.RPGMC Kangra  
 
Primary Sponsor  
Name  DRRPGMC Kangra  
Address  VPO Tanda Kangra Himachal Pradesh 176001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kanan Rambani  Dr.RPGMC Tanda At Kangra  Antenatal Ward,Department of Obstetrics and Gynecology
Kangra
HIMACHAL PRADESH 
7986488185

Kananrambani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee Dr.RPGMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  To Compare Oral Vs Vaginal Misoprostol Along With transcervical foleys catheter For induction of labor In Pregnant Women  GROUP A will receive 25 micrograms misoprostol per vaginally which will be repeated every 4 hourly to a maximum of 5 doses or until they go into labor. 
Intervention  To Compare Oral Vs Vaginal Misoprostol Along With transcervical foleys catheter For induction of labor In Pregnant Women  All the women participating in the study will be inserted with transcervical foleys catheter inflated with 60cc balloon after which they will be randomized in the two groups. GROUP A will receive 50 micrograms misoprostol orally which will be repeated every 4 hourly to a maximum of 5 doses or until they go into labor. In both groups when the cervix will become favourable ie. Bishop score of 6 or the patient will be in active phase of labor (defined as cervical dilation of 3cm or more), misoprostol will be discontinued and further management will be decided as per standard labor room protocol (WHO partographic management). Oxytocin infusion will be started in patients who have not developed adequate contractions. Monitoring will be employed in all patients and labor will be managed partographically. If women do not go into active labor 4 hours after the fifth dose, artificial rupture of membranes followed by oxytocin infusion will be done.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. fetal malpresentations
2. rupture of membranes/ pre-existing chorioamnionitis
3. previous uterine surgery( CS/ hysterotomy/ myomectomy/metroplasty)
4. multifetal gestation
5. antepartum bleeding
6. intrauterine fetal demise
7. Anencephaly
8. allergy to latex.
9. All contraindications to vaginal delivery (eg carcinoma cervix, structural pelvic abnormalities eg rachitic pelvis, Cephalopelvic disproportion.)
10. A previous attempted IOL during current pregnancy.
11. Placenta or vasa previa or cord presentation.
12. Active genital herpes.
13. Contraindications to prostaglandins (eg. Asthma, acute PID, hypersensitivity)
14. Any co-morbid surgical illness (eg. Pyelonephritis, etc)
15. Non reassuring fetal heart rate status.
 
 
ExclusionCriteria 
Details  1. fetal malpresentations
2. rupture of membranes/ pre-existing chorioamnionitis
3. previous uterine surgery( CS/ hysterotomy/ myomectomy/metroplasty)
4. multifetal gestation
5. antepartum bleeding
6. intrauterine fetal demise
7. Anencephaly
8. allergy to latex.
9. All contraindications to vaginal delivery (eg carcinoma cervix, structural pelvic abnormalities eg rachitic pelvis, Cephalopelvic disproportion.)
10. A previous attempted IOL during current pregnancy.
11. Placenta or vasa previa or cord presentation.
12. Active genital herpes.
13. Contraindications to prostaglandins (eg. Asthma, acute PID, hypersensitivity)
14. Any co-morbid surgical illness (eg. Pyelonephritis, etc)
15. Non reassuring fetal heart rate status.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To measure induction-delivery interval.  At the time of delivery (O HOURS- SINGLE OBSERVATION AT BASELINE) 
 
Secondary Outcome  
Outcome  TimePoints 
Duration from IOL to active phase of labor ( defined as ≥ three or more painful contractions in 10 minutes, 80% or greater effacement or cervical dilation of more than 3 cm).  As mentioned above. 
delivery rates  Within 12 and 24 hours of induction of labor 
Proportion of women undergoing CS in both groups.  after delivery of the woman. 
Incidence of failure of Induction.   4 hours post 5th dose of misoprostol. 
• Incidence of hyperstimulation in two groups ( hyperstimulation defined as a single contraction lasting for more than 2 minutes or 5 or more contractions in 10 minutes with fetal heart rate changes)  not applicable 
Meconium stained liquor.  not applicable 
Incidence of chorioamnionitis ( defined as maternal temperature of more than 38 Celsius during and after labor).  during and post 48 hours of delivery 
Neonatal outcomes including: Apgar score (1 min & 5 min),Need of phototherapy (if required; duration),Intensive care admission (if required)
 
After delivery 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Induction of labor (IOL) implies stimulation of contractions before the spontaneous onset of labor, with or without ruptured membranes. It is an intervention designed for iatrogenic ripening of cervix and to initiate uterine contractions leading to progressive dilatation and effacement of cervix resulting into birth of the newborn. It is indicated only when the risks of continuing pregnancy outweigh the benefits to the mother and the fetus.

Methods of IOL presently in use include various mechanical, pharmacological or a combination of mechanical and pharmacological.

Mechanical methods include use of various agents such as transcervical folleys catheter(TCFC) inflated with various amounts of fluid, laminaria tents, synthetic osmotic dilators etc. TCFC is cheap, readily available and easy to use and moreover less painful alternative which affects changes on various components of the bishop score and does not cause overstimulation of the uterus and does not increase the risk of rupture or intrauterine infection and does not adversely affect the fetus and newborn.   However its potential side effects include premature rupture of membranes, chorioamnionitis, bleeding, displacement of presenting part and futire risk of preterm bith.

Pharmacological methods of IOL include agents such as oxytocin, prostaglandins, relaxin, nitic oxide donors such as isosorbide mononitrate, mifepristone etc out of which prostaglandins are the most widely used agents which include various sub classes such as PGE1 ie. Misoprostol and PGE2 known commonly as dinoprostone which is being used as gel and tablet, has the advantage of being used intracervical or vaginally   but is expensive and needs refrigeration. Misoprostol originally used as gastroprotective agent , has advantage of being cheap, stable at room temperature and easy to be administered by various routes i.e. vaginal, oral, sublingual or rectal  where the former two routes of administration are most commonly used .

Absorption by oral route is more rapid than vaginally administered misoprostol reaching peak serum concentrations within 30 min compared to one hour with vaginal route. Oral misoprostol is eliminated rapidly (2–3 h)  than vaginal (>=4 h). In 2014, a Cochrane review on the use of orally administered misoprostol for IOL suggested that vaginal misoprostol was less effective than oral misoprostol at achieving vaginal birth, with an increased risk of uterine tachysystole and CS with vaginal misoprostol 

Nowadays, a combination approach using pharmacological and mechanical methods is followed for IOL. Whereas misoprostol is more effective in improving the scores of cervical length and consistency, TCFC is better at improving the cervical dilatation score at pre-induction cervical ripening; thus, both improve different parameters. Both oral and vaginal routes of misoprostol for IOL have its merits and demerits and its efficacy and safety as an adjunct with TCFC has not been widely studied. IOL may lead to longer lengths of stay, increased hospital costs and increased newborn and maternal morbidities. In order to mitigate these risks,  it is important to choose methods of IOL which are safe and efficacious in achieving a vaginal delivery.

Hence, we plan to compare TCFC with  oral vs vaginal misoprostol as an adjunct for IOL in pregnant women at term. 
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