| CTRI Number |
CTRI/2025/08/093709 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Birth companion support training intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Birth Companion Training on First-Time Mothers’ Childbirth Experience, Labor Process, and Support at AIIMS Gorakhpur |
|
Scientific Title of Study
|
Effectiveness of Birth Companion Training Module on Childbirth Experience, Labor Outcomes, and Birth Companion Support Satisfaction Among Primigravida Mothers at AIIMS Gorakhpur: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Bharti |
| Designation |
M.sc Nursing Student |
| Affiliation |
College of nursing All India institute of medical science Gorakhpur |
| Address |
College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh
Pin code- 273008
Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
9304325147 |
| Fax |
|
| Email |
shivanibharti74@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deviga T |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing All India institute of medical science Gorakhpur |
| Address |
College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh
Pin code- 273008
Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
8003991332 |
| Fax |
|
| Email |
deviga.thirush@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deviga T |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing All India institute of medical science Gorakhpur |
| Address |
College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh
Pin code- 273008
Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
8003991332 |
| Fax |
|
| Email |
deviga.thirush@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shivani Bharti |
| Address |
College of Nursing MNC Building
AIIMS Gorakhpur Uttar Pradesh pin code - 273008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shivani Bharti |
All India Institute of Medical Sciences, Gorakhpur |
Obstetrics and Gynecology Department AIIMS Gorakhpur Gorakhpur UTTAR PRADESH |
9304325147
shivanibharti74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee AIIMS Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Birth Companion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Birth Companion Support Training |
The Birth Companion Training Module (BCTM) is a structured educational intervention designed to prepare selected birth companions to provide effective support to primigravida mothers during labor and childbirth. The training focuses on equipping companions with the knowledge and skills to offer emotional, physical, informational, and advocacy support in accordance with WHO recommendations and national guidelines on respectful maternity care. The content includes topics such as the importance of companionship during childbirth, techniques for providing reassurance and comfort, assisting with mobility and basic needs, communicating hospital procedures to the mother, and maintaining infection control practices. The module is delivered in a 1–2 hour interactive session through lectures, visual aids, demonstrations, and Q&A, conducted by trained midwives or nurse educators. Training is provided 1–2 days before the expected date of delivery or upon admission to the antenatal ward. The intervention group consists of mothers whose companions receive this structured training, while the control group receives routine care without the training. Compliance is monitored using attendance records, support activity checklists, and feedback forms from both mothers and companions post-delivery. |
| Comparator Agent |
Routine Birth Companion Support |
Birth companions in the control group will accompany the primigravida mothers during labor and childbirth without receiving any formal training or orientation. They will provide routine, informal support as per their own understanding and experience, without structured guidance on evidence-based practices. No specific materials, demonstrations, or sessions will be provided to them. The mothers and companions in this group will receive standard institutional care during labor and delivery, as per hospital protocol, without any additional instructions regarding supportive care techniques or communication strategies. Data on maternal childbirth experience, labor outcomes, and birth companion support satisfaction will be collected and compared to the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Birth companions should be selected by primigravida mothers and must be available during the labor process. They should also be willing to undergo and actively participate in the training sessions. Preference is given to female birth companions who are open to taking part in the training programs designed for them. |
|
| ExclusionCriteria |
| Details |
The exclusion criteria include birth companions of mothers with high-risk pregnancies that require specialized or emergency care. Additionally, companions who already have professional medical or midwifery training are excluded to maintain uniformity in the training approach. Birth companions who are unable to communicate or understand the language used in the training sessions and study tools are also excluded. Furthermore, if the mother and her companion are unwilling to participate consistently throughout the training period.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study found that the Birth Companion Training Module significantly improved the childbirth experience by enhancing emotional support and reducing maternal anxiety. It led to shorter labor durations, decreased need for pain relief, and fewer medical interventions. Birth companions reported higher confidence and satisfaction in their supportive role. |
4th Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study revealed a significant association between the childbirth experience of primigravida mothers and selected demographic variables such as age, education, socioeconomic status, and family type. Mothers from nuclear families with higher education and better socioeconomic backgrounds reported a more positive childbirth experience. |
at baseline and 4th Week |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
15/09/2025 |
| 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="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivanibharti74@gmail.com].
- For how long will this data be available start date provided 01-07-2026 and end date provided 01-07-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study, titled “Effectiveness of Birth Companion Training Module on Childbirth Experience, Labor Outcomes, and Birth Companion Support Satisfaction Among Primigravida Mothers at AIIMS Gorakhpur – A Randomized Controlled Trial”, aims to develop and evaluate a structured birth companion training module. The primary objectives are to assess its effectiveness on labor outcomes and childbirth experience and to compare the level of birth companion support satisfaction among primigravida mothers. The secondary objective is to determine the association between childbirth experience and selected demographic variables. The research adopts a true experimental design with an open-label, post-test-only control group using a parallel approach. Conducted at the OBG OPD of AIIMS Gorakhpur, the study targets female birth companions chosen by booked primigravida mothers. A purposive sampling technique is applied, followed by computer-generated random allocation using the envelope method, with a total sample size of 60 participants equally divided into intervention and control groups. Inclusion criteria require birth companions to be willing, available during labor, and able to attend training sessions, while exclusion criteria include high-risk pregnancies, prior professional medical or midwifery training, language barriers, and unwillingness to participate fully. The intervention group undergoes two face-to-face training sessions on emotional and physical support techniques, positioning, breathing exercises, and effective communication with healthcare providers, delivered through demonstrations and audiovisual aids. The control group receives only standard hospital guidance. Data is collected using a sociodemographic performa, a labour outcomes checklist based on the WHO Labour Care Guide, the Birth Companion Support Satisfaction Checklist, and the Labour Agentry Scale-10 (LAS-10). The procedure involves four phases: recruitment and baseline assessment, training implementation, post-training knowledge and skill assessment, and post-delivery evaluation within 12 hours to capture labor outcomes, childbirth experience, and support satisfaction. The study is delimited to booked primigravida mothers and their chosen female birth companions at AIIMS Gorakhpur, with the sample restricted to 60 participants. |