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CTRI Number  CTRI/2025/04/084699 [Registered on: 13/04/2025] Trial Registered Prospectively
Last Modified On: 10/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes
Behavioral
Other (Specify) [Reproductive health care & prevention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Acupressure applied by midwives on pregnant women, after Delivery, and for assessing newborn Outcomes at LI4, GB21, and SP6 Acupoints among Women during the First Stage of Labor. 
Scientific Title of Study   Effects of Midwife-Centered Acupressure (MID-CURE) at LI4, GB21 and SP6 points on Maternal, Delivery and Neonatal outcome among primi-parturient women during first stage of labour admitted in Tertiary care hospital: A Double-Blinded Randomized Sham Controlled Clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Sakila Basnet 
Designation  Assitant Professor 
Affiliation  Sikkim Manipal College of Nursing, Sikkim Manipal University 
Address  Ms Sakila Basnet Sikkim Manipal College of Nursing Sikkim Manipal University 5th mile Tadong,Gangtok

East
SIKKIM
737102
India 
Phone  08370999458  
Fax    
Email  emerald.basnett@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Barkha Devi 
Designation  Associate Professor 
Affiliation  Sikkim Manipal College of Nursing, Sikkim Manipal University 
Address  Dr Barkha Devi Sikkim Manipal College of Nursing Sikkim Manipal University 5th mile Tadong,Gangtok, Sikkim

East
SIKKIM
737102
India 
Phone  7479278673  
Fax    
Email  barkha.d@smims.smu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Barkha Devi 
Designation  Associate Professor 
Affiliation  Sikkim Manipal College of Nursing, Sikkim Manipal University 
Address  Dr Barkha Devi Sikkim Manipal College of Nursing Sikkim Manipal University 5th mile Tadong,Gangtok, Sikkim

East
SIKKIM
737102
India 
Phone  7479278673  
Fax    
Email  barkha.d@smims.smu.edu.in  
 
Source of Monetary or Material Support  
Sikkim Manipal College of Nursing, Sikkim Manipal University 5th mile Tadong Gangtok Sikkim 737102 
 
Primary Sponsor  
Name  Ms Sakila Basnett 
Address  Level 2, CRH Building, Sikkim Manipal College of Nursing, Sikkim Manipal University,5th mile Tadong, Gangtok 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Self  Level 2, CRH Building, Sikkim Manipal College of Nursing, Sikkim Manipal University,5th mile Tadong, Gangtok 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Barkha Devi  Sikkim Manipal College of Nursing, Sikkim Manipal University  Level 2, CRH Building, Sikkim Manipal College of Nursing, Sikkim Manipal University,5th mile Tadong, Gangtok
East
SIKKIM 
7479278673

barkha.d@smims.smu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMIMS INSTITUTION ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Primi Parturient women in first stage of labour 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Midwife Centered Acupressure (MID-CURE)- LI4 point, GB21 point, SP6 point  •Midwife Centered Acupressure (MID-CURE): Midwife acupressure involves using specific acupressure techniques during labour and postpartum care to support the birthing process, maternal wellbeing and neonatal wellbeing. In this study it refers to complimentary therapy where Midwife (Researcher) trained in Acupressure techniques on the points such as LI4,GB21 and SP6 as non-invasive method to support primi-parturient women during intra-natal care. •LI4 point: It refers to the treatment point Acupressure Hugo point (LI4), or Large Intestine 4 located on the back of the hand between the base of the thumb and index finger or on the medial midpoint of the first metacarpal within the skin of the thumb and the index finger. • GB21 point: It refers to the treatment point Acupressure Jianjing” (GB 21) is in the middle of an imaginary line that runs from the bony prominence of the neck to the top of the shoulder joint. Its at the highest point of the shoulder muscle and at the midpoint of the line which connects the prominent vertebra and the acromion. •SP6 point: It refers to the treatment point Acupressure Sanyinjiao Point (SP6) located above the ankle, on the backside of the shinbone (lower calf). It’s about the distance of four finger widths above the inner ankle bone  
Comparator Agent  SP6 4, GB21, LI4 and Sham Control Group  In this study it refers to the Standard care along with acupressure administered to the control group through inactive procedure (touch) that mimics the active procedure of acupressure therapy 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Primi parturient women in spontaneous labour with intact membrane.
In First stage of labour.
Estimated fetal weight of 2.5 - 4 kgs.
No Significant Medical History or past obstetrics history and without any pregnancy complications.
 
 
ExclusionCriteria 
Details  Primi-parturient women in use of Epidosin, or Tab Misoprost.
Pregnancy after infertility.
With Cognitive deficits or impairments.
Refusal to continue participation in the study, receiving pain relief drugs 3 hours before or during the study, labour induction or enhancement by medication. during the study  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To determine the efficacy of Midwife-centered acupressure (MID-CURE) on maternal, delivery, and neonatal outcome among primi-parturient women in the first stage of labour within and between LI4, GB21 and SP6 intervention groups and sham control group   1 years 
 
Secondary Outcome  
Outcome  TimePoints 
1. To estimate the maternal, delivery, and neonatal outcome among primi-parturient women before the application of MID-CURE at LI4, GB21 and SP6 intervention groups and sham control group
2. To determine the difference in maternal, delivery, and neonatal outcome among primi-parturient women after the application of at LI4, GB21 and SP6 intervention groups and sham control group
3. To determine association between maternal, delivery, and neonatal outcome among primi-parturient women in LI4, GB21 and SP6 intervention groups and sham control group with their selected variables.
4. To estimate the Satisfaction with MID-CURE among primi-parturient women after the application of at LI4, GB21 and SP6 intervention groups
 
3 years 
 
Target Sample Size   Total Sample Size="292"
Sample Size from India="292" 
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 2 
Date of First Enrollment (India)   03/11/2025 
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="0"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Acupressure has been used as a complementary therapy for labor pain management and to potentially facilitate labor progression. By using acupressure at specific points, the study seeks to examine whether it improves maternal and neonatal outcomes and provides a safer, less invasive alternative to pharmacological pain relief methods. The randomized controlled design allows for rigorous testing of the hypothesis and can help establish whether there is a real benefit to acupressure over a sham treatment. If the study finds positive results, it could lead to the wider adoption of acupressure as a non-pharmacological tool for managing labor pain and improving outcomes for both mothers and newborns. The study may also contribute to the broader understanding of how complementary therapies can be integrated into maternity care, particularly in settings like tertiary care hospitals where women may have access to more resources. MID-CURE refers to a midwife-centered approach to applying acupressure during labor, particularly at specific acupuncture points. LI4 (Hegu): Known to help with labor pain relief and facilitate the progression of labor. GB21 (Jianjing): Thought to aid in labor progression and provide pain relief. SP6 (Sanyinjiao): A common point used to help with uterine contractions and reduce labor pain. The intervention aims to evaluate the effects of acupressure applied at these points during the first stage of labor. Neither the participants (women in labor) nor the healthcare providers administering the acupressure know whether the participant is receiving real acupressure or a sham (placebo) treatment. Participants are randomly assigned to either the acupressure treatment group or a control group receiving a sham treatment. This helps to control for the placebo effect. This is a trial where participants are assigned to either the treatment or control group to study the outcomes. The participants are primi-parturient women (women experiencing their first childbirth) who are in the first stage of labor. This is a critical phase when labor begins and progresses with regular contractions but before the cervix fully dilates. Tertiary Care Hospitals: These are advanced medical centers where high-risk pregnancies and deliveries are managed, and they typically have specialized personnel like midwives who can provide care during labor.

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