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CTRI Number  CTRI/2025/03/082029 [Registered on: 10/03/2025] Trial Registered Prospectively
Last Modified On: 22/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of Induction of Labor with Mifepristone and Intracervical Dinoprostone Gel Versus Intracervical Dinoprostone Gel alone in Term Pregnancy 
Scientific Title of Study   Efficacy and Feto Maternal Outcome of Induction of Labor with Mifepristone and Intracervical Dinoprostone Gel Versus Intracervical Dinoprostone Gel alone in Term Pregnancy A Double Blind Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kondapalli Sai Santoshi Prathyusha 
Designation  PG Resident, MS- OBG 
Affiliation  Sri Venkateshwaraa Medical College Hospital & Research Centre - Puducherry 
Address  Sri Venkateshwaraa Medical College Hospital and Research centre Department of Obstetrics And Gynaecology 1st floor Ariyur Pondicherry

Pondicherry
PONDICHERRY
605102
India 
Phone  7893786454  
Fax    
Email  chandprathyusha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Nirmala Jaget 
Designation  MS- OBG, Unit Chief 
Affiliation  Sri Venkateshwaraa Medical College Hospital & Research Centre - Puducherry 
Address  Sri Venkateshwaraa Medical College Hospital and Research centre Department of Obstetrics And Gynaecology 1st floor Ariyur Pondicherry

Pondicherry
PONDICHERRY
605102
India 
Phone  7893786454  
Fax    
Email  drnirmalajaget@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr.Kondapalli Sai Santoshi Prathyusha 
Designation  PG Resident , MS- OBG 
Affiliation  Sri Venkateshwaraa Medical College Hospital & Research Centre - Puducherry 
Address  Sri Venkateshwaraa Medical College Hospital and Research centre Department of Obstetrics And Gynaecology 1st floor Hospital block Ariyur Pondicherry

Pondicherry
PONDICHERRY
605102
India 
Phone  7893786454  
Fax    
Email  chandprathyusha@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateshwaraa Medical College Hospital and Research Centre Ariyur Puducherry 605107 INDIA  
 
Primary Sponsor  
Name  kondapalli sai santoshi prathyusha 
Address  Sri Venkateshwaraa Medical College Hospital and Research centre DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY Ariyur Pondicherry 
Type of Sponsor  Other [self] 
 
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 
Kondapalli Sai Santoshi Prathyusha  Sri Venkateswaraa Medical College Hospital and Research Centre  DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY OBS-ICU , 2ND FLOOR 13-A, Pondy-Villupuram Main Road, Ariyur, Puducherry-605102 DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY OBS ICU- 2ND FLOOR 13A Pondy Villupuram Main Road, Ariyur, Puducherry 605 102
Pondicherry
PONDICHERRY 		 7893786454

chandprathyusha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL-ETHICS-COMMITTEE[HUMAN STUDIES]113/SVMCH/IEC-Cert/February24  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 
Intervention  drug given in study group T.MIFEPRISTONE 200mg   T.MIFEPRISTONE 200mg per oral once during the study 
Comparator Agent  placebo in control group T.FERROUS SULPHATE 200mg  T. FERROUS SULPHATE 200mg per oral once during the study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  term pregnant females eligible for induction of labour
cephalic presentation
live fetus
reactive non stress test 
 
ExclusionCriteria 
Details  not eligible for induction of labour 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
vaginal delivery   initially after induction, 24 hours later
later every 6 hours [ maximum of 18 hours] 
 
Secondary Outcome  
Outcome  TimePoints 
assisted vaginal delivery, ceaserean delivery  initially after induction,
after 24 hours
later every 6 hours for maximum of 3 times 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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   Phase 3 
Date of First Enrollment (India)   20/03/2025 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (chandprathyusha2gmail.com).

  6. For how long will this data be available start date provided 05-04-2024 and end date provided 01-05-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  		 Ante-natal women who are full filling inclusion criteria and have valid indications of induction of labour like postdated   pregnancy, Premature rupture of membranes, pregnancy induced hypertension, gestational diabetes mellitus, oligohydramnios, Intrauterine growth restriction etc. will be included in the study

INCLUSION CRITERIA:

Valid indications for induction of labour like postdated pregnancy, Premature rupture of membranes, pregnancy induced hypertension, gestational diabetes mellitus, oligohydramnios, Intra uterine growth restriction etc. are included in the study.

1) Maternal age ≥ 18 years

2) Term pregnancy ≥37 weeks

3) Singleton pregnancy

4) Cephalic presentation

5) Live fetus

6) Reactive Non-Stress Test

6)Modified Bishop’s score <6

 

EXCLUSION CRITERIA: 

     Women with any contraindication to induction and vaginal delivery

       Incomplete data

       Estimated fetal weight ≥ 4.5 kg or ≤ 2.0 kg

       Antepartum Hemorrhage (Abruption Placenta, Placenta Previa)

       Previous caesarean sections

        Abnormal Doppler studies and Non stress test.

       Severe Oligohydramnios [AFI< 5]

      Chorioamnionitis

       Major Cephalopelvic disproportion

       Parity > 4

       Patients requiring immediate delivery

       Severe pre-eclampsia, eclampsia

       Intrauterine death

       Heart disease complicating pregnancy

 

METHODS:

After Ascertaining inclusion and exclusion criteria and obtaining written and informed consent 220 women will be enrolled in the study 110 in each group. Detailed history of all the patients taken according to the proforma and complete clinical examination and necessary investigations are done.

Women will be randomized into two groups according to computer generated randomized table. The number of participants in study group will be 110 and control group will be 110.

PI will give the participants the drug packet according to computer generated randomized numbers and drug packet number is noted in proforma.

Study will be double blinded, both participant and PI will be blinded

At the end of study, proforma number will be tallied with computer generated table , if it is placebo or the drug.

 Pre-induction Bishop score will be noted.

 Women randomized to study group will receive one tablet Mifepristone 200 mg per oral at the moment of enrollment. The participants in control group will receive placebo and bishop score noted for two groups.

After 24 hours, both groups will receive dinoprostone gel 0.5 mg after 6 hours Bishop’s score will be checked again, intracervical dinoprostone gel repeated 6 hourly for total of 3 doses if bishop score <8

Before each dose of dinoprostone gel fetal wellbeing will be evaluated by clinical examination and Cardiotocography.

 Augmentation with oxytocin will be done when warranted.

 If with 3 doses of dinoprostone gel the bishops score not improved then the induction will be categorized as failed induction.

 When the women entered in active labor, augmentation of labor will be done by using Oxytocin drip, but not earlier than 6 hours from last dose of intracervical dinoprostone gel application.

 Induction to delivery interval will be noted in both the groups.

 Mode of delivery will be noted

 Maternal and neonatal outcome/ complications will be noted


Purpose of the study

                                Induction of labor is an obstetric procedure, it is designed to pre attempt the natural process of labor by initiating its onset artificially, before labor occurs spontaneously. When continuation of pregnancy presents a threat to the life or well-being of the mother or unborn child. The infant should be delivered in a good condition, in an acceptable time frame and with minimal maternal discomfort or side effects. The aim of successful induction is to achieve vaginal delivery

                          Induction of labor has two important components, cervical ripening and stimulation of uterine contractions to achieve dilation of cervix and delivery of the fetus. It is well recognized that the success of induction of labor, which ultimately aims at achieving vaginal delivery, depends to a great extent on the favorability of the cervix or its readiness to go into labor. Agents used for cervical ripening may lead in the establishment of contractions to women with unfavorable cervix. Pharmacological methods like Prostaglandins (PGE1, PGE2) and mechanical methods like Hygroscopic cervical dilators, membrane stripping, trans cervical catheter, etc. are available for pre induction cervical ripening.

                          Mifepristone, an antiprogesterone is a receptor level antagonist. Mifepristone ,19-norsteroid has great affinity for the progesterone receptor and thus blocks the action of progesterone at cellular level and its smooth muscle relaxing effect and increasing the sensitivity of the uterus to the action of prostaglandins.

                              Present study is being done to evaluate the efficacy of addition of mifepristone with dinoprostone gel in induction of labour with the outcome of induction and fetomaternal effects

 
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