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CTRI Number  CTRI/2025/10/096483 [Registered on: 27/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Breast crawl technique]  
Study Design  Other 
Public Title of Study   The study to assess how the a natural process where a newborn, placed on its mothers abdomen or chest immediately after birth, uses its instincts to move towards the breast and begin breastfeeding on its own and Affect on time of delivery of placenta after babys birth 
Scientific Title of Study   A study to assess the effectiveness of breast crawl technique on breastfeeding among newborn and its impact on 3rd stage of labour among intranatal mothers at selected health care centers of Anand district. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ekta Patel 
Designation  Assistant Professor 
Affiliation  Institute of Nursing Sciences, Karamsad 
Address  Room no. 205, Institute of Nursing Sciences, Bhaikaka University, Gokal Nagar, Karamsad

Anand
GUJARAT
388325
India 
Phone  8347433558  
Fax    
Email  ektapatel501@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ekta Patel 
Designation  Assistant Professor 
Affiliation  Institute of Nursing Sciences, Karamsad 
Address  Room no. 205, Institute of Nursing Sciences, Bhaikaka University, Gokal Nagar, Karamsad


GUJARAT
388325
India 
Phone  8347433558  
Fax    
Email  ektapatel501@gmail.com  
 
Details of Contact Person
Public Query  
Name  Hinal Parmar 
Designation  M. Sc. Nursing Student 
Affiliation  Institute of Nursing Sciences, Karamsad 
Address  Classroom no. 206, Institute of Nursing Sciences, Bhaikaka University, Gokal Nagar, Karamsad

Anand
GUJARAT
388325
India 
Phone  7567258973  
Fax    
Email  hinalparmar6620@gmail.com  
 
Source of Monetary or Material Support  
Infrastructure support- Shree Krishna Hospital, Gokal nagar, Karamsad, dist: Anand, Gujarat, India Pin code: 388325 
 
Primary Sponsor  
Name  Shree Krishna Hospital 
Address  Gokal nagar, Karamsad, dist: Anand, Gujarat, India Pin code: 388325 
Type of Sponsor  Private hospital/clinic 
 
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 Nitin Raithatha  Shree Krishna Hospital, Karamsad  Room no. 240, Professor office, Obstetrics & Gynecology Dept., Shree Krishna Hospital, Gokal nagar, Karamsad, Gujarat, India- 388325
Anand
GUJARAT 		 02692228224

nitinsr@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaikaka University, Karamsad, Anand, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O927||Other and unspecified disorders oflactation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Breast crawl technique  The present study will aim to evaluate the effectiveness of the breast crawl technique on breastfeeding initiation and maintenance among newborns and its impact on the third stage of labor among intranatal mothers. Participants will be selected using the block randomization method and divided into experimental and control groups. The experimental group will receive the breast crawl intervention, in which the newborn is placed on the mother’s abdomen immediately after birth to self-initiate breastfeeding, while the control group will receive routine care. Data will be collected using a self-structured breast crawl assessment checklist, modified LATCH assessment tool, Bristol breastfeeding assessment tool, and a clinical assessment sheet for third-stage labor. The study will assess initiation and maintenance of breastfeeding as well as duration of the third stage of labor, comparing both groups to determine the effectiveness of the technique. It is expected that the experimental group will show earlier initiation and better maintenance of breastfeeding, along with a shorter duration of the third stage of labor, indicating that the breast crawl technique is an effective, natural, and evidence-based method to enhance maternal and neonatal outcomes in clinical settings. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  In this study, the pregnant women were selected based on the inclusion criteria: Pregnant women-
1. With normal healthy pregnancy without any underlying medical condition.
2. Who underwent normal vaginal delivery between 37 to 42 weeks of gestation.
3. Who is pregnant with single fetus.
4. with or without mild to moderate anemia.
5. Whose baby follows the scoring criteria of breast crawl assessment checklist. 
 
ExclusionCriteria 
Details  The pregnant women excluded from the study who had 1.Any past or present history of placenta Previa, abruption placenta.
2.Prolonged or obstructed labor.
Intrauterine fetal growth retardation, intrauterine fetal death, stillbirth and fetus distress.
3.ny abnormality of breast and nipple like engorgement, tenderness, inverted, retracted or cracked nipples.
4.Severe anemia
5.Newborn with congenital anomaly related to GI tract like cleft lip and cleft palate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of breast crawl technique in initiation and maintenance of breast feeding among newborn.  After 3 days of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of breast crawl technique on 3rd stage of labor among intranatal mothers.  During delivery 
To identify association between initiation and maintenance of breastfeeding with sociodemographic variables.  At baseline data and after 3 days of intervention 
To identify association between 3rd stage of labor with sociodemographic variables.  At baseline data 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2025 
Date of Study Completion (India) 02/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
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   The present study will aim to evaluate the effectiveness of the breast crawl technique on breastfeeding initiation and maintenance among newborns and its impact on the third stage of labor among intranatal mothers. Participants will be selected using the block randomization method and divided into experimental and control groups. The experimental group will receive the breast crawl intervention, in which the newborn is placed on the mother’s abdomen immediately after birth to self-initiate breastfeeding, while the control group will receive routine care. Data will be collected using a self-structured breast crawl assessment checklist, modified LATCH assessment tool, Bristol breastfeeding assessment tool, and a clinical assessment sheet for third-stage labor. The study will assess initiation and maintenance of breastfeeding as well as duration of the third stage of labor, comparing both groups to determine the effectiveness of the technique. It is expected that the experimental group will show earlier initiation and better maintenance of breastfeeding, along with a shorter duration of the third stage of labor, indicating that the breast crawl technique is an effective, natural, and evidence-based method to enhance maternal and neonatal outcomes in clinical settings. 
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