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CTRI Number  CTRI/2024/04/065413 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   As a method to aid spontaneous labor  
Scientific Title of Study   Effectiveness of nipple stimulation technique in aiding spontaneous onset of labor in low risk primigravida 
Trial Acronym 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. GEETHANJALI ADDALA 
Designation  MS, OBGY 
Affiliation  KMC, Manipal 
Address  Department of OBGY, Women and child block, Kasturba medical college, Tiger circle road, Madhav nagar, Manipal
Kasturba medical college, Tiger circle road, Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9441740777  
Fax  -  
Email  geethanjaliaddala@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. SUJATA B.S. 
Designation  Associate professor 
Affiliation  KMC, Manipal 
Address  Department of OBGY, Women and child block, Kasturba medical college, Tiger circle road, Manipal
Kasturba medical college Tiger circle road, Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  8660778169  
Fax  -  
Email  bssujata@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR. PRATHIKSHA. K 
Designation  Assistant professor  
Affiliation  KMC, Manipal 
Address  Department of OBGY, Women and child block, Kasturba medical college, Tiger circle road, Madhav nagar, Manipal
Kasturba medical college, Tiger circle road, Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9880691709  
Fax  -  
Email  prathiksha.k1991@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 
Geethanjali addala  Kasturba Hospital, Manipal  Department of OBGY, Women and child block, Kasturba medical college, KMC, Manipal
Udupi
KARNATAKA 
9441740777

geethanjaliaddala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND 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: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil since it is an observational study 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Low risk primigravida who completed 37weeks of gestation with cephalic presentation, and no other medical (such as diabetes, hypertension, hypothyroidism etc,) and surgical complications. 
 
ExclusionCriteria 
Details  Those who have medical and surgical complications and other pregnancy related complications such as cephalo-pelvic disproportion, h/o assisted reproductive techniques and those who are not willing for the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To be observed in both groups in the form of maternal, fetal outcomes. Maternal outcomes such as change in the Bishop’s score after 2 weeks, spontaneous or induced labour, Induction for post-datism, mode of delivery, duration of labour and any hyperstimulation, meconium-stained liquor

Fetal outcomes such as Apgar score at 5 mins, requirement of neonatal intensive care unit admission, neonatal morbidities like sepsis, asphyxia, jaundice, respiratory distress, fetal or neonatal death. 
at the time of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
Final Enrollment numbers achieved (Total)= "142"
Final Enrollment numbers achieved (India)="142" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/04/2024 
Date of Study Completion (India) 20/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Low risk Primigravida who are at 37completed weeks of gestation, fitting the inclusion criteria will be recruited from the OPD during their routine antenatal visit to the hospital. A baseline cervical scoring using Bishop’s score will be done along with pelvic assessment and those with cephalopelvic disproportion will be excluded. These low risk pregnant women will be provided charts explaining the technique of nipple stimulation and its advantages as per
the consultant’s advice. The women who are consenting for the study will be taken as stimulation group and those are not willing for the study will be taken as non- stimulation group (each with sample size of 71). This nipple stimulation is a standard method of practice in some units, as it helps in cervical ripening and timely onset of labour without use of any pharmacological means. These women will be followed weekly in their regular weekly
antenatal follow up. No extra visits will be required for this study. They will be advised to keep a daily dairy of the manoeuvre and to be shown in the subsequent visit. At 39weeks, these women are to be followed up and those who has not done the manoeuvre will be excluded from the study. A repeat Bishop’s score has to be done at 39+ weeks of gestation, and changes in the cervical scoring to be noted in both the groups. These women will be
advised to attend immediately to the obstetric casualty in case of pain abdomen associated with tightening, leaking or bleeding PV or decreased fetal movements.
 
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