| CTRI Number |
CTRI/2024/07/070501 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of midwife led antenatal intervention package on shared awareness of primigravida women and their maternal and neonatal outcome. |
|
Scientific Title of Study
|
A study on effectiveness of midwife led antenatal intervention package on shared awareness of primigravida women and their maternal and neonatal outcome in selected healthcare facility of Uttar Pradesh. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bindiya Gupta |
| Designation |
PhD Scholar |
| Affiliation |
Swami Rama Himalayan University |
| Address |
Room No 15,
First Floor,
OBG department,
Himalayan College of Nursing ,
Swami Rama Himalayan University,
Swami Ram Nagar, Jolly Grant,
Uttarakhand
Dehradun
UTTARANCHAL
248016
India |
| Phone |
9810595369 |
| Fax |
|
| Email |
bggoel3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanchan Bala |
| Designation |
Associate Professor |
| Affiliation |
Swami Rama Himalayan University |
| Address |
Room No 15,
First Floor,
OBG department,
Himalayan College of Nursing ,
Swami Rama Himalayan University,
Swami Ram Nagar, Jolly Grant,
Uttarakhand
Dehradun
UTTARANCHAL
248016
India |
| Phone |
8958031610 |
| Fax |
|
| Email |
kanchanbala@srhu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Bindiya Gupta |
| Designation |
PhD Scholar |
| Affiliation |
Swami Rama Himalayan University |
| Address |
Room No 15,
First Floor,
OBG department,
Himalayan College of Nursing ,
Swami Rama Himalayan University,
Swami Ram Nagar, Jolly Grant,
Uttarakhand
Dehradun
UTTARANCHAL
248016
India |
| Phone |
9810595369 |
| Fax |
|
| Email |
bggoel3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kailash Institute of Nursing and Paramedical Sciences |
|
|
Primary Sponsor
|
| Name |
Bindiya Gupta |
| Address |
Room No 15,
First Floor,
OBG department,
Swami Rama Himalayan University
Himalayan College of Nursing ,
Swami Rama Himalayan University,
Swami Ram Nagar, Jolly Grant,
Uttarakhand
248016 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bindiya Gupta |
Community Health Centre Badalpur |
Obstetrics and Gynecology OPD, Room No 1, Badalpur near Vertax Hyundai, NH 91, Greater Noida Uttar Pradesh 203207
Gautam Buddha Nagar
UTTAR PRADESH |
9810595369
bggoel3@gmail.com |
| Bindiya Gupta |
Community Health Centre Dadri |
Obstetrics and Gynecology
Department , Room No 5,
Infront of Police Station Main GT Road, NH 91, Dadri, Uttar Pradesh 203207
Gautam Buddha Nagar
UTTAR PRADESH |
9810595369
bggoel3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Superintendent , CHC Badalpur |
Approved |
| Superintendent , Dadri CHC |
Approved |
| Swami Rama Himalayan University Ethics Committee , Dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O251||Malnutrition in pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Midwife Led Antenatal Intervention Package (MLAIP) |
It’s a midwife led multicomponent Intervention Package developed to empower primigravida women by increasing their health awareness and to improve their maternal and neonatal outcome. It will contain topics like Know your Pregnancy , Antenatal Care and Visits ,Govt Schemes Related to MCH, RMC-Know your Rights, Minor Ailments and Management , Personal Hygiene and Self-care, Antenatal Anemia , Nutrition, Exercise, Fetal attachment and Stress Management, Child Birth-Preparation and Complication Readiness, Exclusive Breast Feeding, Family Planning and Kangaroo Mother Care . The package will be delivered in 4 sessions of 1 to 1 ½ hour duration each, to the experimental group.
Session I -first trimester--60 to 90 minutes . Session II and III in Second trimester--60 to 90 minutes each and Session IV in third trimester--60 to 90 minutes.
Total Duration of intervention is nearly 32 weeks. |
| Comparator Agent |
Routine Antenatal care given to pregnant women. |
Routine antenatal education and counselling . Duration nearly 32 weeks |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Primigravida women in first trimester of pregnancy.
2.Antenatal registered and plan to deliver with the selected healthcare facilities.
3.Singleton pregnancy and willing to keep the pregnancy. |
|
| ExclusionCriteria |
| Details |
1.History of habitual abortion.
2.Known case of chronic illness like HT, DM, Psychiatric illness etc
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved KAP Score
Maternal Neonatal outcome |
taken for each trimester of pregnancy
taken within 24 hours of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maternal Satisfaction/ opinion measured using a valid tool |
taken within 24 hours of delivery |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
01/08/2024 |
| 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="1"
Months="6"
Days="0" |
|
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
|
The study aims to assess the shared awareness of primigravida women visiting community health centre regarding various aspects of Antenatal Care and visits like Antenatal Assessment, Management of Minor Ailments , Lifestyle Changes during Pregnancy ( diet, nutrition, exercise etc.), Fetal attachment and Stress Management, Child Birth-Preparation and Complication Readiness, Exclusive Breast Feeding, Family Planning etc. and develop and implement a multicomponent Midwife Led Antenatal Intervention package in the experimental group. The study hypothesized that primigravida women in experimental group will have increased shared awareness and improved maternal neonatal outcome than primigravida women in control group at p< 0.05.
|