| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnant women with seizure disorder and pregnant women without any comorbid condition, |
|
|
Intervention / Comparator Agent
|
|
|
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. |