| CTRI Number |
CTRI/2021/07/034823 [Registered on: 14/07/2021] Trial Registered Prospectively |
| Last Modified On: |
12/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effectiveness of child birth preparedness video teaching among pregnant women. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to assess the effectiveness of midwife led video assisted child birth preparedness teaching on maternal and neonatal outcomes among antenatal women in Obstetrics units of PGIMER, Chandigarh, 2020-22. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishu |
| Designation |
MSc Nursing |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no 207, MSc Nursing, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8427975369 |
| Fax |
|
| Email |
rishu.jamwal1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rishu |
| Designation |
MSc Nursing |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no 207, MSc Nursing, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8427975369 |
| Fax |
|
| Email |
rishu.jamwal1994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
V Venkadalakshmi |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no 319, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855552533 |
| Fax |
|
| Email |
venkadalakshmi_v@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rishu |
| Address |
Room no 208, MSc Nursing, National Institute of Nursing Education, PGIMER, Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| V Venkadalakshmi |
Room no 319, National Institute of Nursing Education, PGIMER, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rishu |
Post Graduate Institute of Medical Education and Research |
Room no 2034, Antenatal OPD, 2nd floor, New OPD and
Clean Labour Room, 3rd floor, D-block, Nehru hospital.
Chandigarh
CHANDIGARH |
8427975369
rishu.jamwal1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
NA |
NA |
| Intervention |
Video assisted child birth preparedness teaching, 32-37 weeks of period of gestation |
antenatal exercises, financial arrangement, transport arrangement, arrange blood donor, hospital bag for delivery, mothers preparation before coming for delivery, sign and symptoms of onset of labour, true and false labour pain, danger signs of labour, types of delivery, labour stages and management, breastfeeding, newborn care, postpartum perineal care, postpartum danger signs in women, danger signs in newborn, family planning methods. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women (POG 32-37weeks) willing to participate, Able to speak or understand Hindi/English/Punjabi |
|
| ExclusionCriteria |
| Details |
Not candidate for NVD, high risk pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maternal outcome- Duration of labour, Mode of delivery, Use of analgesics, Initiation of breastfeeding within 1hr, Length of hospital stay, Postpartum complication. Neonatal outcome- APGAR score, Birth weight, Neonatal complication |
After delivery and 3day/discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge regarding birth preparedness and anxiety |
At 37weeks of period of gestation |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
15/07/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
After completion of the study I will publish results |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study conducted with objective to assess the effectiveness of video assisted child birth preparedness teaching on level of knowledge, anxiety, maternal and neonatal outcomes among antenatal women. Study participants will be enrolled from July 2021. |