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CTRI Number  CTRI/2019/02/017708 [Registered on: 19/02/2019] Trial Registered Prospectively
Last Modified On: 13/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To see how the circumferenc eof babys head and length of cervix in the mother affect the type of delivery and outcomes in baby. 
Scientific Title of Study   Impact of Head Circumference and cervical length on induction of labour and labour outcomes 
Trial Acronym  HCCL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Duvva Sai Bhavana 
Designation  Junior Resident 
Affiliation  Kasturba Hospital, Manipal 
Address  Department of Obstetrics and Gynaecology, Kasturba Hospital, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9008209973  
Fax    
Email  saibhavana.d93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sapna V amin 
Designation  Associate Professor 
Affiliation  Kasturba Hospital, Manipal 
Address  Department of Obstetrics and Gynaecology, Kasturba Hospital, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9880916061  
Fax    
Email  drsapnagoni@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sapna V amin 
Designation  Associate Professor 
Affiliation  Kasturba Hospital, Manipal 
Address  Department of Obstetrics and Gynaecology, Kasturba Hospital, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9880916061  
Fax    
Email  drsapnagoni@rediffmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Kasturba Hospital 
Address  Department of OBG,Kasturba Hospital, Manipal, udupi, karnataka, India- 576104 
Type of Sponsor  Research institution and hospital 
 
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 Sapna V Amin  Kasturba Hospital  Labour wards, Department of Obstetrics and Gynaecology, Manipal, India
Udupi
KARNATAKA 		 9880916061

drsapnagoni@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  37 weeks-40 weeks 3 days POG
Singleton pregnancy
EFW 2.5 - 3.5kg
Cephalic presentation  
 
ExclusionCriteria 
Details  Elective C section due to CPD, previous LSCS, IUGRetc
Spontaneous vaginal delivery
Antepartum hemorrhage (placenta praevia, abruption)
Breech, transverse lie
Previous H/O any uterine surgeries- previous LSCS, myomectomy
Any unanticipatied event in labor like abruption, cord prolapse 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Modes of delivery- normal vaginal deliveries, forceps and vacuum assisted
deliveries, Emergency LSCS
Fetal outcomes- APGAR score, NICU stay, other neonatal complications. 		 August 2020 
 
Secondary Outcome  
Outcome  TimePoints 
To determine if Ultrasonographically measured parameters like Head circumference and cervical length measured prior to induction of labour are better predictors of succesful induction than the conventional bishops score.   August 2020 
 
Target Sample Size   Total Sample Size="470"
Sample Size from India="470" 
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)   24/02/2019 
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="2"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   All pregnant patients meeting the Inclusion criteria will be recruited for the study. Informed consent will be taken from patient and a witness. Patient information sheet with the study details will be provided to them. patient details will be filled in the proforma. Per abdomen palpation of fetal head will be done by Crichton’s manoeuvre. Per vaginal examination will be done to measure cervical length, dilatation, position, consistency and station of head ( Bishop’s score).  Head circumference measured any time after 36 weeks will be considered. Cervical length will be measured by Transvaginal sonography by strict aseptic techniques. Patients will be induced according to  Kasturba hospital protocol with Cerviprime/ Misoprostol. They will be followed up till delivery. The mode of delivery will be noted- vaginal/ instrumental / emergency LSCS. The APGAR score of the newborn at 1 and 5 mins will be noted. Other fetal outcomes like respiratory distress syndrome, necrotising enterocolitis, sepsis, NICU stay, need for assisted ventilation, etc will be noted. It will be determined if head circumference and cervical length are important predictors of successful induction of labour. 
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