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CTRI Number  CTRI/2018/05/013831 [Registered on: 11/05/2018] Trial Registered Retrospectively
Last Modified On: 08/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Outcomes of seizure disorder in pregnancy 
Scientific Title of Study   Maternal And Perinatal Outcome in Pregnant Women with Seizure Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tarang Preet Kaur 
Designation  Postgraduate 
Affiliation  Maulana Azad Medical College 
Address  39-B, Raghudeep Hospital, Narain Singh Park, Panipat

Panipat
HARYANA
132103
India 
Phone  9971779382  
Fax    
Email  tarang.preet@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Latika Sahu 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department office, Obstetrics and gynaecology, Lok Nayak Hospital, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9968604400  
Fax    
Email  latikasahu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Latika Sahu 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department office, Obstetrics and gynaecology, Lok Nayak Hospital, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9968604400  
Fax    
Email  latikasahu@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  2, Bahadur Shah Zafar Road, Balmiki Basti, New Delhi, Delhi 110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tarang Preet Kaur  Maulana Azad Medical College  2, Bahadur Shah Zafar Road, Balmiki Basti, New Delhi, Delhi 110002
Central
DELHI 
9971779382

tarang.preet@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pregnant women with seizure disorder and pregnant women without any comorbid condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Case- Pregnant women with known case of seizure disorder with first ANC visit between 18-28 weeks
Control- Pregnant women without any comorbid condtion 
 
ExclusionCriteria 
Details  Pregnant women with eclpamsia at the time of enrolment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study obstetric outcome in women with seizure disorder when compared to women without seizure disorder in terms of maternal complications such as antenatal, intranatal and fetal outcome  15 months 
 
Secondary Outcome  
Outcome  TimePoints 
NONE  15 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/09/2016 
Date of Study Completion (India) 10/01/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Seizure disorder is a condition characterised by the episode of abnormal, uncontrolled neuronal activity in the brain resulting in various manifestations ranging from dramatic convulsive activity, altered consciousness , abnormal sensations to experiential phenomena not readily discernible by an observer. Epilepsy as described by ILAE 2014 includes atleast 2 unprovoked (or reflex) seizures occurring more than 24 hours apart. Seizure disorder has a prevalence of 1.65% in adults, and every 1 in 200 pregnancies encounters its complications which makes it the second most common neurological problem encountered in pregnancy after headaches. Seizure disorder in reproductive woman could be attributed to idiopathic, trauma, brain tumour, autoantibodies, alcohol withdrawal, cerebrovascular disease, metabolic disorders (uraemia, hepatic failure, electrolyte abnormalities, renal failure, hypoglycaemia, hyperglycaemia). Women with seizure disorder are considered at high risk in pregnancy with maternal mortality 10 times higher than women without seizure disorder. Individual studies provide varied and imprecise estimates of the association between seizure disorder and pregnancy complications such as antenatal (pregnancy induced gestational hypertension, preeclampsia, GDM, miscarriage, APH, preterm delivery, FGR), intranatal (need for induction of labour, caesarean section) , postnatal (PPH), Fetal (low birth weight babies, need for NICU admission, congenital foetal anomalies, still births). Evidence tends to be focussed on foetal harm from in utero exposure to AEDs or on severity of maternal seizures with less emphasis on other pregnancy outcomes. Understanding of the disease and its potential effects on pregnancy is essential for providing appropriate pre pregnancy counselling and optimum management during pregnancy and delivery. Furthermore a vast number of AEDs should be investigated for their teratogenic effects. It was stated that newborns exposed to anti- epileptic drugs (AEDs) in utero have 2–3-fold higher (3.3–9%) prevalence of major congenital abnormalities compared to unexposed newborns. Congenital malformations such as cleft lip and palate, cardiac defects, neural tube defects (NTDs), skeletal abnormalities, and hypospadias have been shown to occur as a result of intrauterine exposure to AEDs. These malformations are observed more frequently with increased doses of AEDs, higher serum levels of AEDs and polytherapeutic approaches.  Folic acid may also be responsible for the occurrence of major complications to some degree as folic acid supplementation in women under anticonvulsant medications has been shown to decrease malformation rates. Therefore, as the outcome of women with seizure disorder in obstetric practice is unclear, in this study we aim to study the obstetric outcome in women with seizure disorder in terms of maternal and perinatal complications and establish whether pregnant women with seizure disorder have an increased risk of complications compared to a control group of matched healthy pregnant women without seizure disorder.

 
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