| CTRI Number |
CTRI/2025/08/092260 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal prospective study |
| Study Design |
Other |
|
Public Title of Study
|
How Pregnancy Emotions Affect Birth and Baby: A study of first time mothers. |
|
Scientific Title of Study
|
Prenatal depression, fear of childbirth, expectations, neonatal outcomes and childbirth experiences among Primigravida women: a longitudinal prospective study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Najnina Khatun |
| Designation |
Clinical Instructor |
| Affiliation |
Government College of Nursing, I D B G Hospital Campus, Kolkata-10 |
| Address |
Government College of Nursing,
I D B G Hospital Campus, Kolkata-10
Kolkata
WEST BENGAL
700010
India |
| Phone |
9051889106 |
| Fax |
|
| Email |
khanshikha16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alpanamayi Bera |
| Designation |
Principal |
| Affiliation |
College of Nursing, Medical College and Hospital, Kol-73 |
| Address |
College of Nursing,
Medical College and Hospital,Kolkata-73
Kolkata
WEST BENGAL
700073
India |
| Phone |
9831357924 |
| Fax |
|
| Email |
alpanamayi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Najnina Khatun |
| Designation |
Clinical Instructor |
| Affiliation |
Government College of Nursing, I D B G Hospital Campus, Kolkata-10 |
| Address |
Government College of Nursing
I D B G Hospital Campus
Kolkata-10
Kolkata
WEST BENGAL
700010
India |
| Phone |
9051889106 |
| Fax |
|
| Email |
khanshikha16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Calcutta National Medical College and Hospital, Kolkata 700014, West Bengal |
|
|
Primary Sponsor
|
| Name |
Najnina Khatun |
| Address |
Government College of Nursing
I D B G Hospital Campus, 57, Beleghata Main Road, Beleghata,Kolkata-10, West Bengal |
| 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 |
| Najnina Khatun |
Calcutta National Medical College and Hospital |
OPD of Obstetrical Dept, Postnatal Ward, Calcutta National Medical College an Hospital, 32, Gorachand Road, Kol-700014
Kolkata
WEST BENGAL |
9051889106
khanshikha16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Calcutta National Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primigravida Woman |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida who are able to listen and communicate verbally and who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Primigravida who have existing mental illness, medical and surgical illness complicating pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prenatal depression, Childbirth fear, Childbirth expectations,Neonatal outcomes Childbirth experience. |
Prenatal depression will be assessed two times i.e at second and third trimester, Childbirth fear and expectations will be assessed at third trimester,Neonatal outcomes will be assessed after 24 hours of birth and Childbirth experience will be assessed at 4-6 weeks of delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postpartum depression |
6 weeks after delivery |
|
|
Target Sample Size
|
Total Sample Size="425"
Sample Size from India="425"
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)
|
08/09/2025 |
| 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="1"
Months="0"
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (khanshikha16@gmail.com).
- For how long will this data be available start date provided 08-11-2026 and end date provided 08-11-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Prenatal depression,
fear of childbirth, expectations, neonatal outcomes and childbirth experiences
among Primigravida women: a longitudinal prospective study.
Background: The childbirth
experiences are multi factorial. Different variables are responsible tin
evaluations of childbirth experiences, including midwifery support, duration of
labour pain, involvement and participation in labour, invasive labour process.
Despite the improvement of maternity care, fear of childbirth is common problem
during pregnancy. Satisfaction of birth is also associated with women’s
emotional aspect. Prenatal depression has some adverse effect on newborn
including preterm birth and low birth weight. Women have positive experiences
if their expectations during childbirth are met. The early the women see, hold
their newborn after delivery the more positive birth experience could be seen
among them. Childbirth fear is considered as a reason for the increase in the
number of women requesting elective caesarean section. Women who delivered by caesarean section were
less likely to feed their newborns shortly after delivery and reported less
positive birth experiences. (p <0.001). There is little investigation in the
field of birth experience and neonatal outcome. Longitudinal study may identify
predictors of childbirth experience to provide useful information to health
care providers and policy makers that promote positive childbirth experiences. Aim: To assess the status
of prenatal depression, fear of childbirth, expectations, neonatal outcomes and
childbirth experience. Methodology: Type of study- Institutional based
descriptive observational study. Study design: Longitudinal prospective study.
Study area: OPD of Obstetrical Dept. and Postnatal ward of Calcutta
National Medical College and Hospital, Kolkata, West Bengal. Study
population: Primigravida. Research variables: - Prenatal
depression, fear of childbirth, expectation, neonatal outcome, Childbirth
experience. Socio demographic variable: Age, occupation, monthly income,
education, gestational age, mode of delivery, duration of labour, delivery
conducted by. Sampling technique: Systematic random sampling. Sample
size: 425 Expected outcomes: Different responsible factors for
childbirth experience and their role will be identified. At present there are
no guidelines to evaluate or treat pregnant women who suffer from prenatal
depression, childbirth fear or to assess their expectations. Until such
guidelines are developed, findings from this study can help health care
providers identify and address specific expectations, depression and childbirth
fear, neonatal outcomes and understand how those factors relate to satisfaction
with care. |