| CTRI Number |
CTRI/2024/05/067593 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse-led protocol] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the effectiveness of Nurse-led postpartum support on selected maternal outcomes of postnatal mothers of hospitalized preterm neonates. |
|
Scientific Title of Study
|
A quasi-experimental study to assess the effectiveness of Nurse-led postpartum support on selected maternal outcomes of postnatal mothers of hospitalized preterm neonates in Nehru hospital,PGIMER, Chandigarh, 2023-25 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Mishra |
| Designation |
M.Sc.(Nursing) Student |
| Affiliation |
PGIMER,Chandigarh |
| Address |
National Institute of Nursing Education(NINE), PGIMER Chandigarh.
Department of Obstetric and gynecology, Room Number-10
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7985641198 |
| Fax |
|
| Email |
mishraricha744@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Richa Mishra |
| Designation |
M.Sc.(Nursing) Student |
| Affiliation |
PGIMER,Chandigarh |
| Address |
National Institute of Nursing Education(NINE), PGIMER Chandigarh
Department of Obstetric and gynecology, Nursing Division Room Number-10 Under Mr. Bhim Singh Rawat Associate Professor PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7985641198 |
| Fax |
|
| Email |
mishraricha744@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa Mishra |
| Designation |
M.Sc.(Nursing) Student |
| Affiliation |
PGIMER,Chandigarh |
| Address |
National Institute of Nursing Education(NINE), PGIMER Chandigarh.
Department of Obstetric and Gynecology, Nursing Division Room Number 10 Under Guidance of Mr. Bhim Singh Rawat Associate Professor
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7985641198 |
| Fax |
|
| Email |
mishraricha744@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Richa Mishra |
| Address |
National Institute of Nursing Education, PGIMER Chandigarh |
| Type of Sponsor |
Other [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 |
| Richa Mishra |
Nehru Hospital PGIMER Chandigarh |
Nehru Hospital Third floor, Obstetric and Gynecology department, Labor room extension and mothers Room Under Dr. Snigdha Kumari Associate Professor, PGIMER
Chandigarh
CHANDIGARH |
7985641198
mishraricha744@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"Nurse-led postpartum support" protocol for mothers |
"Nurse-led postpartum support" protocol for mothers for 20 days of intervention planned |
| Comparator Agent |
Routine Care |
Routine Care it will be continue after 20 days also |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Postnatal mothers with gestational age between 28 to 37 weeks.
Those neonates are admitted in NNN, NICU and labor room |
|
| ExclusionCriteria |
| Details |
Postnatal mothers who have any neurological and psychiatric problems.
Postnatal mothers who have poor score of general health questionnaire |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep, Absence of postnatal complication, physical Recovery, livel of stress in mothers, Maternal-infants bonding, weight gain in neonates, duration and frequency of breastfeeding |
Baseline data, at the time of discharge(2 weeks), after 15 days of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| weight gain in neontes, duration and frequency of breastfeeding |
3 months |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
01/07/2024 |
| 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="0"
Months="3"
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 - NO
|
|
Brief Summary
|
There is limited research on the health needs and health seeking behaviors like level of stress, maternal infant bonding, physical recovery of the mother, duration and frequency of breastfeeding, weight gain in neonates, sleep, absence of postnatal complication is there. Indian researches related to all this components of a postpartum mothers are lacking, no studies in the context of all these outcome variables are present, so to addrss this gap our study will be conducted which ultimately be a nurse-led postpartum support for mothers whose preterm neonates are admitted in the NICU and explore one methods for chancing access to health services Null Hypothesis There will not be any significant impact of ’Nurse-led Postpartum Support" on selected maternal Outcome of postnatal mothers of hospitalized preterm neonates at 0.05 level of significance. Alternatives Hypothesis There will be significant impact of "Nurse-led Postpartum Support on selected maternal outcomes of postnatal mothers of hospitalized preterm neonates at 0.05 level of significance. |