| CTRI Number |
CTRI/2024/09/073652 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of stress during pregnancy on mode of delivery, birth weight and gestational age of newborn babies |
|
Scientific Title of Study
|
Effect of maternal stress on mode of delivery and birth outcomes of newborns
an observational 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 |
Malayaka Khah |
| Designation |
Student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy department, Room number 510, Kuamrhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8368934008 |
| Fax |
|
| Email |
malayakakhah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pooja Mehra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy department, Room number 510, Kuamrhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9896644741 |
| Fax |
|
| Email |
mehra.drpooja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pooja Mehra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy department, Room number 510, Kuamrhatti, Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9896644741 |
| Fax |
|
| Email |
mehra.drpooja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, 173229, India |
|
|
Primary Sponsor
|
| Name |
Malayaka Khah |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| 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 |
| Dr Pooja Mehra |
Maharishi Markandeshwar University |
Maharishi Markandeshwar University, Department of Obstetrics and Gynecology, Kuamrhatti, Solan
Solan
HIMACHAL PRADESH |
9896644741
mehra.drpooja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MM Medical College and Hospital |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Mothers aged 20 to 35 years.
2. Pregnant women with singleton pregnancy.
3. Mode of delivery: Vaginal delivery (Spontaneous or Assisted), Caesarean Section (Elective or Emergency)
4. Fetal outcomes: Day 1 of delivery (Gestational age, Apgar score, Birth weight,
Complications during delivery). |
|
| ExclusionCriteria |
| Details |
1. Pre-existing medical conditions.
2. Pregnancy complications.
3. Mental health conditions (if diagnosed).
4. Drug or Alcohol abuse during pregnancy.
5. Smoking during pregnancy.
6. Language barrier. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percieved stress scale |
baseline one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Birth weight
APGAR score
Gestational age |
One time |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
20/09/2024 |
| 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="6"
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
|
Women often experience certain events or situations during their pregnancies
known as pregnancy-related stress. Numerous factors can promote stress during pregnancy,
such as physical health issues like illness and discomfort, changes in lifestyle, insufficient
social support, unintended pregnancies, low income, shifting roles, hormonal and
physiological changes, and expectation of childbirth, and violence from partners before and
after pregnancy. Pregnancy is a critical time for neurodevelopment of newborns; it is an
exceptionally delicate time. Over this period, it has been found that several stress-related
events in mothers can have long-term consequences on an infant’s behavior and brain
development, which may have an effect on both mental and physical health. In previous studies, information is focused on postpartum stress and its effects on mother’s
health and infant’s development. But this study focuses on maternal stress during/throughout
the pregnancy. Studying the effect of maternal stress on mode of delivery and birth outcomes
of newborns is crucial for several reasons as maternal stress can influence fetal development
through physiological pathways, such as hormonal changes, which can impact the growth and
development of the fetus. High maternal stress levels are associated with adverse birth
outcomes, including preterm birth and low birth weight. Early life stress exposure can have
long-term effects on a child’s health, including cognitive development, behaviour, and
susceptibility to chronic diseases. Understanding these links can help in developing long term
strategies for child health and development. |