| CTRI Number |
CTRI/2025/10/096696 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
how neurological problems affect mothers and babies during pregnancy and after delivery |
|
Scientific Title of Study
|
Spectrum of neurological disorders in pregnancy and puerperium and their feto-maternal outcomes: A one-year 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 |
Srusti Dandamudi |
| Designation |
Junior Resident 1 |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Obstetrics and Gynecology department, first floor, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka, India,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7730084518 |
| Fax |
|
| Email |
dandamudisrusti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shridevi Metgud |
| Designation |
Associate professor of department of Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru medical college, JNMC Campus, KLE university , Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7353195431 |
| Fax |
|
| Email |
Shridevi.metgud@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shridevi Metgud |
| Designation |
Associate professor of department of Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru medical college, JNMC Campus, KLE university , Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7353195431 |
| Fax |
|
| Email |
Shridevi.metgud@gmail.com |
|
|
Source of Monetary or Material Support
|
| JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka,India,590010 |
|
|
Primary Sponsor
|
| Name |
SrustiDandamudi |
| Address |
Obstetrics and Gynecology department, first floor, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka,India,590010 |
| 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 |
| DrSrusti Dandamudi |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi |
Obstetrics and Gynecology department, first floor, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka,India,590010
Belgaum
KARNATAKA |
07730084518
dandamudisrusti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O993||Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All antenatal women and women in puerperium with neurological symptoms or disorders are included |
|
| ExclusionCriteria |
| Details |
Antenatal women and women in puerperium who do not have neurological disorders are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the spectrum of neurological disorders in pregnancy and puerperium |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the Fetal & maternal outcomes & risk factors in women with neurological disorders in pregnancy & the puerperium. |
one year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/11/2025 |
| 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="0"
Months="0"
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
|
Neurological diseases in pregnancy can be classified into three categories: a.Pre-existent chronic neurological diseases such as epilepsy and multiple sclerosis.b.Diseases with onset predominantly in pregnancy brain tumours or cerebrovascular events. c.Pregnancy-induced conditions such as eclampsia and Haemolysis elevated liver enzymes and low platelets syndrome. Due to its rare occurrence in pregnancy, a high degree of suspiciousness and involvement of the concerned team is needed for the diagnosis and management of the patient. The altered physiology during pregnancy imposes a challenge to diagnose the various disorders. The duration of pregnancy and concern regarding the fetus make it tricky to choose appropriate investigation and treatment. The pregnant woman is vulnerable in that many medications and diagnostic evaluations are avoided due to concerns of causing harm to the fetus . As neurological diseases contribute to approximately 20 percent of maternal deaths. For those with neurological disorders, preconception planning provides an opportunity for discussion of pregnancy impact on disease, the effect that disease impairment may have on pregnancy, and use of treatment for disease control during pregnancy. Pre-conception counselling plays an integral role because neurologic disease holds potential for significant contribution to morbidity and mortality in pregnancy Preconception counselling is crucial for managing neurological diseases in pregnancy. It helps to identify potential risks and reduce harm for the patient, fetus, and neonate. This proactive approach not only allows for the optimization of neurologic health but also fosters patient education about pregnancy risks and provides time and integrated care to intervene for ultimate pregnancy success. The key integral components of preconception assessment for patients with neurological disorders include understanding patient history, performing a physical exam, and reviewing neuroimaging and medications. Additional considerations may be important for the postpartum period or breastfeeding. However, it’s important to note that all women with pre-existing neurological disorders must have excellent communication with all involved physicians. Counselling and risk assessment should involve a multidisciplinary care team such as obstetricians, neurologists, neurosurgeons, anaesthesiologists, geneticists, and neonatologists. This ensures comprehensive care and better outcomes for the patient and the baby. This study enhances our understanding of the range of neurological disorders that can occur during pregnancy and the postpartum period at our hospital. Timely and accurate diagnosis are essential for initiating treatment and improving both maternal and fetal outcomes. There are gaps in knowledge in our region, and a deeper understanding of these disorders is crucial for improving our services and for reducing maternal and fetal mortality and morbidity.
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