FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/06/043188 [Registered on: 13/06/2022] Trial Registered Prospectively
Last Modified On: 11/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trail to study the efficacy and safety of two types of dinoprostone medication ( single application of slow release vaginal insert VS multiple dose gel) for labor initiation  
Scientific Title of Study   A randomized control trial comparing efficacy and safety of controlled release dinoprostone vaginal insert and dinoprostone gel for labor induction  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Attibele Palsksha Manjunatha 
Designation  Senior Specialist 
Affiliation  Sultan Qaboos University Hospital  
Address  Department of Obstetrics and Gynecology Sultan Qaboos University Hospital Al Khod Sultanate of Oman
Al Khod Muscat Sultanate of Oman


123
Other 
Phone  0096894422740  
Fax    
Email  manjunathattibele@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Attibele Palsksha Manjunatha 
Designation  Senior Specialist 
Affiliation  Sultan Qaboos University Hospital  
Address  Department of Obstetrics and Gynecology Sultan Qaboos University Hospital Al Khod Sultanate of Oman
Al Khod Muscat Sultanate of Oman


123
Other 
Phone  0096894422740  
Fax    
Email  manjunathattibele@gmail.com  
 
Details of Contact Person
Public Query  
Name  Attibele Manjunath Manjunatha 
Designation  Senior Specialist 
Affiliation  Sultan Qaboos University Hospital  
Address  Department of Obstetrics & Gynecology Sultan Qaboos University Hospital Al Khod, Sultanate of Oman
Al Khod, Muscat Sultanate of Oman


123
Other 
Phone  0096894422740  
Fax    
Email  manjunathattibele@gmail.com  
 
Source of Monetary or Material Support  
Sultan Qaboos University Hospital 
 
Primary Sponsor  
Name  Sultan Qaboos University Hospital 
Address  Department of Obstetrics and Gynecology Sultan Qaboos University Hospital Al Khod, Sultanate of Oman  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Oman  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nihal Al Riyami  Sultan Qaboos University Hospital  P.O Box 36, Department of Obstetrics and Gynecology Al Khod, Sultanate of Oman

 		 0096897014445

nihal@squ.edu.om 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medical Research Ethics Committee College of Medicine & Health Sciences Sultan Qaboos University  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  controlled release dinoprostone vaginal insert (Propess)   Propess is placed in the posterior fornix of the vagina with about 2 cm of the tape is left outside the vagina, the women is instructed to lie down for 20-30 min after insertion while monitoring with CTG. The onset and progress of labour (uterine contractions, bishop score and fetal heart rate is regularly monitored as per departmental protocol. The insert is removed when the patient enters active labour or if there is any sign of maternal or fetal compromise (hyper stimulation, vaginal bleeding or abnormal CTG). The vaginal insert can be kept for a maximum of 24 hours from insertion.  
Comparator Agent  dinoprostone gel (Prostin)   Prostin is PGE2 vaginal gel is placed in the posterior fornix of the vagina to avoid cervical canal. Women is advised to lie for 30 min with ongoing CTG for 15 min. The end point for cervical ripening are strong uterine contractions and bishop score more than six. Repeat prostin gel insertion every six hours for maximum of four dose, if end point is not achieved. Attempt to remove remaining prostaglandin with other supportive measures are initiated if excessive uterine contractions.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Singleton pregnancy
Term pregnancy of 37 weeks or more
Cephalic presentation Bishop score 6 or less, Intact or ruptured membranes. The following women will be excluded. 
 
ExclusionCriteria 
Details  Previous scared uterus (cesarean section, extensive myomectomy involving the uterine cavity, previous uterine rupture or dehiscence), Para 4 or more, multiple pregnancy, estimated fetal weight more than 4 kilograms, abnormal CTG (cardiotocogram). Any contraindication for vaginal delivery (placenta previa, malpresentation, active genital herpes infection). Women with contraindication or hypersensitive to dinoprostone. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome - Induction to vaginal delivery interval - Need for oxytocin to augment labour occurrence of hyper stimulation, non-reassuring CTG - Mode of delivery - APGAR score, cord pH & NICU admissions - Maternal morbidity during labour Sample size is calculated from previous 6 years data
 		 End point for cervical ripening are strong uterine contractions , bishop score 6. Induction of labour will be considered successful if vaginal delivery within 24 hours of induction.  
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction (a scale of 100) after delivery. - Cost effective analysis of the two induction methods - Subgroup analysis based on the Bishop score and parity.
 		 till delivery 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/06/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   not yet published. once trial completed will plan to publish 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Project aims Situations arise in obstetrics it becomes necessary to interrupt pregnancy in the interest of the mother and the fetus. Our main objective would be to evaluate the efficacy, safety of sustained release vaginal pessary, compared to dinoprostone gel.

 Materials and Methods It is a randomized controlled trial comparing dinoprostone vaginal gel and controlled release pessary for induction of labour at Sultan Qaboos University Hospital over 2 years. All eligible, term patients for induction of labour will be recruited. Randomisation sequence will be done using a computer-generated random number and block randomisations. The on call doctor, will allocate and insert the drugs in 1:1 ratio.

Primary outcomes will be induction to delivery interval, number of successful vaginal deliveries and any complications. Secondary outcome measure is to perform the cost effective analysis and patients satisfaction during labour induction process. We will follow the CONSORT 2010 guideline.

 
Close