Seizure 18 (2009) 163–166

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Seizure
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Maternal and obstetric outcome of women with epilepsy

S.V. Thomas a,*, K. Sindhu a, B. Ajaykumar a, P.B. Sulekha Devi b, J. Sujamol b
a
Kerala Registry of Epilepsy and Pregnancy, Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum 695011, India
b
Department of Obstetrics and Gynecology, Medical College, Trivandrum, India

A R T I C L E I N F O A B S T R A C T

Article history: Medical professionals and public are concerned about the complications of pregnancy and delivery in
Received 23 May 2008 women with epilepsy (WWE).
Received in revised form 10 August 2008 Purpose: Our aim was to prospectively ascertain occurrence of these complications in a cohort of WWE
Accepted 15 August 2008
enrolled in a pregnancy registry.
Methods: All complications during pregnancy, delivery and first 48 h of postpartum period were recorded
Keywords:
according to the registry protocol. This data were compared with similar statistics (for women without
Epilepsy
epilepsy) from a large teaching hospital.
Pregnancy
Abortion
Results: Between April 1998 and March 2005, there were 643 completed pregnancies in this registry.
Maternal outcome (Mean age 25.7  4.43 years; generalized epilepsy 46%; localization related epilepsy 54%; primigravida 53%.)
Delivery Their complications are compared with those of 18,272 pregnancies managed in the teaching hospital (in
Seizure parentheses). Spontaneous abortions 4.2% (2.38%); medical termination of pregnancies 2.64% (7.71%); anemia
0.62% (0.22%); gestational diabetes 1.56% (3.09%); pregnancy induced hypertension 3.89% (6.45%);
antepartum hemorrhage 0.93% (1.64%); preterm labor 1.87% (6.12%); obstructed labor 0.62% (3%); cesarean
section 33.4% (29.5%); assisted delivery 2.8% (2.68%); postpartum hemorrhage 0.31% (0.64%); peripartum
seizures 1.4% (0.04%); intrauterine death 1.56% (2.2%); fibroid uterus or ovarian cyst 2.33% (0.53%); other
medical illness 2.5% (2.15%); TORCH infection 0.31% (0.01%); birth weight <2.0 kg 4.19% (7.66%).
Conclusions: There was no significant increase in the risk of complications of pregnancy or delivery except
for spontaneous abortions, anemia, ovarian cyst, fibroid uterus, and seizures in the peripartum period
which were more frequent in WWE. Frequency of cesarean section is not increased in WWE. There is no
undue risk to pregnancy and childbirth in most WWE.
ß 2008 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

1. Introduction matched women without epilepsy.10 Nevertheless, other reports

About 40% of 18 million females with epilepsy in the world are
in the reproductive age group. Women with epilepsy (WWE) are
perceived to have increased risk of complications during preg-
nancy and delivery. WWE tend to marry late, and have fewer
children than women without epilepsy.1 They may have increased
risk of spontaneous abortion, non-proteinuric hypertension,
antepartum hemorrhage, toxemia, induction of labor and caesarian
section when compared to general population.2–6 WWE may have
increased incidence of adverse fetal outcome such as spontaneous
abortion, stillbirths, neonatal deaths, premature deliveries, intrau-
terine growth restriction, microcephaly, and lower neonatal Apgar
scores.3,4,6–9 In a retrospective study, newborns of WWE had lower
anthropometric measurements when compared to newborns of
* Corresponding author. Tel.: +91 471 2524468; fax: +91 471 2446433.
E-mail address: sanjeev.v.thomas@gmail.com (S.V. Thomas).
indicate that there is no significant increase in obstetric
complications or interventions in this group of women.11,12 In a
large population-based survey, rate of obstetric complications and
mode of delivery of WWE were not different from control
women.13 During pregnancy, seizure frequency remained
unchanged (63.6%) or abated (15.9%) in most of the WWE
according to a recent multinational prospective study.14 Although,
considerable amount of data are available on the fetal outcome of
WWE, relatively much less data are available on their obstetric
outcome. The objective of this study is to prospectively ascertain
the obstetric complications in a cohort of WWE.
2. Materials and methods
This study was carried out as a part of the Kerala Registry of
Epilepsy and Pregnancy (KREP) that is operational since April 1998
at Sree Chitra Tirunal Institute for Medical Sciences and
Technology, Trivandrum, in South India. This is a tertiary care

1059-1311/$ – see front matter ß 2008 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.seizure.2008.08.010
164 S.V. Thomas et al. / Seizure 18 (2009) 163–166

epilepsy center. This study has the approval of the Institutional
Ethics Committee and informed consent was obtained from every
registrant. We encourage all WWE to enroll in this registry at the
time of their marriage or as soon as they become pregnant. All
pregnancies are followed up prospectively according to the
registry protocol, the details of which had been published
elsewhere.15,16 Their gynecological and obstetric past history,
and family history including a three generation pedigree chart are
recorded. The neurological examination, seizure history, epilepsy
classification are recorded in the protocol. Details of AED therapy
(daily dose, single maximum dose and number of doses per day)
and folic acid therapy, seizure frequency (partial, generalized and
total number) are recorded on a monthly basis. Each woman is
given a pregnancy diary in which the dates for the review or
laboratory tests and pregnancy landmark dates are marked. At 16
weeks of pregnancy serum alpha fetoprotein is measured and at 18
weeks a malformation targeted ultrasound examination is carried
out. We do not modify the AED therapy except when necessitated
by poor seizure control. Two injections (intra muscular) of Vitamin
K 10 mg are given near term. Details of delivery including any
complications were obtained from the attending gynecologist on a
standard proforma within 1 week of delivery. A detailed clinical
examination, echocardiogram and abdomen ultra sonograms were
carried out on every baby at 3 months of age. We used the
pregnancy and delivery characteristics of women without epilepsy
attending to a large maternity hospital attached to the medical
college for 1 year (n = 18,272) for comparison purpose. Chi-square
test or Fisher’s exact test with p value set at 0.05 was used for
comparison of proportions. Odds Ratio (OR) with 95% confidence
interval (CI) was used for estimating risk.
3. Results
3.2. Complications of pregnancy
The obstetric complications, according to the period of
pregnancy, for WWE are compared with those for women without
epilepsy in Table 1. Anemia, spontaneous abortion, pregnancy
induced hypertension (PIH), pre-eclampsia (PET), peripartum
seizures, intrauterine infections, hypothyroidism and tumors
and cysts of uterus or ovaries—were significantly more for WWE
when compared to controls. The Odds ratio and 95% confidence
interval for these complications were as follows: spontaneous
abortion 1.82 (1.26–2.63), PIH 1.42 (1.05–1.91), PET 2.05 (1.37–
3.06), anemia 2.96 (1.17–7.52), peripartum seizures 30.66 (12.06–
77.94), fibroid 3.14 (1.5–6.59), ovarian cyst 6.32 (2.74–14.57) and
thyroid dysfunction 3.7(1.67–8.24).
There were seven WWE with ovarian cyst; the AEDs used by
them were CBZ (5), PB (1) and VPA (1). There was no significant
association between the occurrence of ovarian cyst and exposure
to any particular AED. There was no significant difference between
the two groups in the occurrence of other complications of
pregnancy.
We compared the complications of pregnancy of women with
GE with those of women with LRE. GE group had significantly
higher frequency (p = 0.01) of abnormal delivery (56.7%) compared
to others (47.5%). Depressive psychosis was significantly (p = 0.04)
more frequent (1.9%) for them compared to those with LRE (0.3%).
There was no significant difference with regard to frequency of
cesarean delivery. The proportion of WWE who were not using
AEDs during index pregnancy was comparable (7.8% and 7.4%) for
Table 1
Complications of pregnancy and delivery for women with epilepsy and healthy
controls

Complications WWE, Control, p

During the period April 1998 to May 2005, there were 808 preg- n (%) n (%)
nancies enrolled in the registry, of which follow up was complete for
n 718 18272
718 pregnancies (88.9%). Others were continuing pregnancies: 52
(6.4%) or lost to follow up: 38 (4.7%). Their mean age (at the time of Early
completion of pregnancy) was 25.6  4.3 years (range 17–42 years). Threatened abortion 9 (1.3) 306 (1.8) 0.39
Spontaneous abortion 32 (4.5) 434 (2.4) 0.0003
The enrollment was in the pre-conception stage for 17.6% women. The
Medical termination of pregnancy 19 (2.6) 1409 (7.7) <0.0001
mean duration of pregnancy for others was 14  10 weeks. There were Hyper emesis 21 (2.9)
322 women with generalized epilepsy (44.8%), 364 with localization
Late
related epilepsy (50.7%) and 32 with unclassified syndromes (4.5%). The
Gestational diabetes 9 (1.3) 565 (3.1) 0.005
mean age of onset of epilepsy was 14.5  6.5 years. Pregnancy induced hypertension 47 (6.5) 853 (4.7) 0.02
Pre-eclampsia 27 (3.8) 325 (1.8) <0.0001
3.1. AED usage during pregnancy Hydramnios 10 (1.4)
Intra uterine growth retardation 61 (8.5)

There were 66 pregnancies (9.2%) without AED exposure. The Labor

AED exposure for others were as follows: single AED 436 (60.7%); Placenta previa 6 (0.8) 172 (0.9) 0.8
Abruptio placentae 1 (0.1) 128 (0.7) 0.07
two AEDs 172 (24%), three AEDs 38 (5.3%) and four AEDs 6 (0.8%).
Anemia 4 (0.6) 41 (0.2) 0.07
The AEDs used were carbamazepine – CBZ 285 (163 as mono- Obstructed labor 6 (0.8) 548 (3) 0.0006
therapy); sodium valproate – VPA 201 (132 as monotherapy); Preterm labor 27 (3.8) 1119 (6.1) 0.009
phenobarbitone – PB 181 (61 as monotherapy); phenytoin – PHT Peripartum seizures 10 (1.4) 8 (0.04) <0.0001
154 (66 as monotherapy); lamotrigine – LTG 18 (7 as mono- Still birth or intrauterine death 11(1.5) 402 (2.2) 0.23
Cerebral venous thrombosis 2 (0.3)
therapy); and other AEDs 79 (topiramate, oxcarbazepine, tiaga-
Vacuum extraction 15 (2.1)
bine, primidone, clonazepam, clobazam, diazepam and Forceps delivery 4 (0.6)
nitrazepam). The proportion of pregnancies without AED exposure Cesarean section 216 (30.1) 5380 (29) 0.7
was comparable for the Generalized Epilepsy - GE (7.8%) and
Postpartum hemorrhage 2 (0.3) 116 (0.6)
Localization Related Epilepsy - LRE (7.4%). Monotherapy was more
frequent with GE (67.4%) than LRE (57.4%). The AEDs used (as Others
Fibroid uterus 7 (1) 62 (0.3) 0.014
monotherapy or polytherapy) for women with GE included VPA Ovarian cyst 7 (1) 27 (0.1) 0.002
(47.8%), PB (27%), CBZ (21.1%), PHT (17.7%), LTG (2.8%) and others Thyroid dysfunction 4 (0.6) 46 (0.3) 0.002
(8.1%). The AEDs used (as monotherapy or polytherapy) for women Rheumatic heart disease 5 (0.7) 211 (1.2) 0.26
with LRE were CBZ (75.1%), PHT (26.4%), PB (25%), VPA (9.9%), LTG Bronchial asthma 1 (0.1) 71 (0.4) 0.29
Congenital heart disease 3 (0.4) 63 (0.3) 0.74
(0.8%) and others (14%). The difference in the AED preference
Maniac depressive psychosis 15 (2.1) 30 (0.2) <0.0001
between GE and LRE was statistically significant (p = 0.001).
 S.V. Thomas et al. / Seizure 18 (2009) 163–166
both groups. GE and LRE subgroups had similar proportions (50.2%
and 55.9%) of women who had seizures during pregnancy
(p = 0.082). The difference in risk of occurrence of seizures during
pregnancy women with GE (50.2%) and LRE (55.9%) were not
statistically significant (p = 0.082). The frequency of other com-
plications of pregnancy was also comparable for these two groups.
Women with GE had similar risk of fetal loss (spontaneous
abortion, medical termination, intrauterine death or stillbirth),
other complications of pregnancy, cesarean section, or risk of
peripartum seizures. There was no statistically significant differ-
ence between those exposed to AEDs and those not exposed to
AEDs (either as monotherapy or polytherapy) with regard to most
complications of pregnancy except for peripartum seizures (see
Table 2).
3.3. Seizures during pregnancy and peripartum period
Precise seizure frequency during pregnancy was not available
for 31 women (4.3%). Nearly half of the patients (n = 323, 47%) had
remained seizure free while others had one or more seizures.
There were only three patients with status epilepticus during
pregnancy. Peripartum seizures were significantly more (p = 0.05)
for women who were not taking AEDs (4.6%), compared to those on
monotherapy (0.5%) and those on polytherapy (2.3%) (see Table 2).
Nevertheless, with regard to occurrence of seizures during
pregnancy (prior to peripartum period), there was no statistically
significant difference between the two groups (44.3% and 53.8%).
The type of epilepsy (GE vs. LRE) had no influence on risk of
seizures during pregnancy. The proportion of WWE who had
seizures during pregnancy for the various AEDs was 66.7% for PHT,
60.7% for PB, 56.7% for CBZ, 49.0% for VPA and 44.4% for LTG.
Seizure relapse was significantly higher with PHT (p < 0.001), CBZ
(p = 0.03) and PB (0.01) and not significantly different for VPA
(0.11) and LTG (0.30).
3.4. Fetal loss
There were 62 (8.65%) cases of fetal loss (spontaneous abortion,
medical termination of pregnancy, intrauterine death or stillbirth).
The risk of fetal loss was highest with VPA (12.4%) and LTG (11.1%),
lesser with PHT (9.1%) and CBZ (7%) and least with PB (5%). There
were 32 instances of spontaneous abortions (4.5%) in the WWE
group, which was significantly higher than those of controls (2.4%).
There was no significant difference in the frequency of abortions
for GE (5.3%) and LRE (3.8%). Within the WWE group, those with
AED exposure had higher OR (1.57) for abortions as compared to
those without AED exposure, but the 95% confidence interval
(0.37–6.72) was not statistically significant.
Spontaneous abortion was least with PB (1.1%). The risk was
higher with CBZ (2.5%), LTG (3.1%), PHT (4.5%), VPA (8%) and other
AEDs (5.1%). The excess risk associated with VPA was statistically
significant (p = 0.006). The mean and (S.D.) duration of pregnancy
at the time of enrollment for the various AEDs were as follows: PB
135(107) days, PHT 127 (103) days, CBZ 119 (108) days, VPA 98
Table 2
Complications of pregnancy (percentage) according to AED therapy
Characteristic No AED Monotherapy Polytherapy
N 66 435 217
Spontaneous abortion 3 5.3
Pregnancy induced hypertension 7.7 6.2
Pre-eclampsia 6.1 4.4
Anemia 0 0.7
Peripartum seizures 4.6* 0.5
*
p = 0.05.
165
Table 3
Antiepileptic drug usage and spontaneous abortion in women with epilepsy
AED N Spontaneous OR 95% CI
abortion
Carbamazepine 285 7 0.40 0.17–0.95
Phenobarbitone 181 2 0.21 0.05–0.91
Valproate 201 16 2.35 1.14–4.83
Phenytoin 154 7 1.12 0.47–2.67
Lamotrigine 17 1 1.09 0.14–8.56
Others 79 4 1.12 0.38–3.32
(99) days, LTG 79 (87) days and other AEDs 115 (105) days. The
difference in time of enrollment was significantly later for
phenobarbitone and earlier for valproate (p < 0.005). The Odds ratio
for spontaneous abortion associated with VPA remained significant
even after adjusting for the duration of pregnancy at the time of
enrollment (see Table 3).
Delivery was conducted by cesarean section for 216 women
(30.1%) which were comparable to that of controls. The mean birth
weight of infants of WWE (2.46  1.1 kg) (95% CI 2.38–2.54) was
lower than that of controls was 3.01  0.9 kg (95% CI 2.99–3.03).
Nevertheless there were fewer (3.43%) low birth weight (less than
2 kg) babies for WWE when compared to controls (7.66%). There was
no case of hemorrhagic disease of new born for the cases or controls.
4. Discussion
Fetal malformations associated with epilepsy and antenatal
exposure to AEDs have been the subject of extensive investigation
for the past several decades. Nevertheless, there had been
relatively much less discussion on the maternal and obstetric
outcome of pregnancies in WWE. Pregnancy registries offer an
excellent platform to prospectively study these aspects in WWE.
This hospital-based registry is unique in enrolling WWE in the pre-
conception period and following them up through the entire
pregnancy and subsequently until the children are over 6 years of
age. The drop out in our cohort was less than 5%.
Our data indicate that most WWE have uneventful pregnancy
and delivery. There is an increased risk of spontaneous abortion,
pregnancy induced hypertension, pre-eclampsia, anemia, and
peripartum seizures as compared to women without epilepsy
attending to a large teaching hospital. A prospective study of
pregnancies in northern region of UK, through community
midwives and review of medical records had shown that WWE
(compared to background population) did not have any excess risk
of complications of pregnancy except for premature labor.17
Spontaneous abortion occurred in 4.5% of pregnancies in WWE
in this cohort. Relatively higher rates (12.6%) of spontaneous
abortions had been reported in an earlier study.7 Stillbirth and
neonatal deaths may be increased by 1.2- to 3-fold for WWE.3,6,7 In
contrast to this, there was no association between abortions and
epilepsy or exposure to AEDs in two population-based studies18,19
and hospital-based studies2,20 (see Table 4). It is important to
take in to consideration the duration of pregnancy at the time
of enrollment in the registry while interpreting the data on
spontaneous abortions. Some of the very early abortions in the first
8–12 weeks may be missed if the enrollment is after 12 weeks of
pregnancy. In our registry, the mean duration of pregnancy for
those exposed to VPA (98  99 days) was significantly earlier than
3.2
that of WWE on other AEDs (see Table 2). Hence, it is likely that very
7.8 early abortions with other AEDs, may be underestimated. We had
3.2 attempted to overcome this difficulty by using a logistic regression to
0.5 negate the effect of duration of pregnancy. The logistic regression
2.3
results showed that the excess risk of spontaneous abortion
associated with VPA persisted even after adjusting for the duration
166 S.V. Thomas et al. / Seizure 18 (2009) 163–166
Table 4
Complications of pregnancy in WWE a comparison of two centers
Maternal characteristic Present study Richmond et al.2
(n = 718), N (%) (n = 414), N (%)
Age at delivery, mean  S.D. (years) 25.6  4.3 29.3  5.1
Hypertension in pregnancy 47 (6.5) 47 (11.4)y
Pre-eclampsia 27 (3.8) 18 (4.4)
Gestational diabetes mellitus 9 (1.3) 17 (4.1)
Placenta previa 6 (0.8) 3 (0.7)
Placental abruption 1 (0.1) 16 (3.9)
Cesarean delivery 216 (30.1) 100 (24.2)
of pregnancy. Hence there appears to be a 2.71-fold increase in the
risk of abortions if the mother is using VPA as and AED.
Labour and delivery were uneventful in most WWE. Similar
findings were observed in another pregnancy registry recently.21
According to another hospital-based case control study, there
were no significant differences between WWE and women
without epilepsy in total length of labor, labor induction and
oxytocin augmentation, need for labor analgesia, total blood loss
and the need for blood transfusion, mode of delivery, and
the length of hospital stay.22 In contrast, the rates of cesarean
section was significantly higher for WWE when compared
to others in a population-based study in Stockholm, Sweden.23
In that study newborns also had higher risk of respiratory
distress.
One or more seizures occurred during pregnancy or post-
partum period for 53% of WWE in this series. There was good drug
compliance as demonstrated in the pregnancy calendar and diary.
Over 9% of WWE in this cohort were not using AEDs during the
index pregnancy. The poorer control of seizures in our patients
may be related to not using the AEDs or the relatively lower
dosage. It had recently been shown that towards 32 weeks of
pregnancy LTG clearance increases three times that in the
preconception phase.24 In a pregnancy registry in Norway,
majority (63%) WWE had remained seizure-free and another
15% had reduction in seizure frequency during pregnancy.21
Nevertheless, WWE had increased likelihood of seizures during
labour and several patients required increase in the dose of AEDs
during labour.22
In one of the earlier studies, infants exposed in utero to
enzyme inducing AEDs had increased bleeding tendency in the
immediate newborn period.25 A more recent study of 22 infants
of mothers with epilepsy did not reveal any increased risk of
bleeding in infants exposed to AEDs when compared to
unexposed infants.26 Observations in another large cohort also
did not suggest any increased risk of neonatal bleeding when
compared to unexposed infants.27 In this present study, both
groups of infants had received 1 mg Vitamin K immediately after
delivery.
5. Conclusion
Most of the WWE had uneventful pregnancy and delivery.
Nevertheless, they had significantly higher frequency of sponta-
neous abortion, PIH, PET, eclampsia, anemia and peripartum
seizures. There was no association between any complication and
the type of maternal epilepsy. WWE who were on PHT, CBZ or PB
had increased risk of peripartum seizures. The frequency of
delivery by cesarean section was higher for WWE even though
uncomplicated epilepsy was not an indication for caesarian
section. Gynecological tumors like ovarian cyst and fibroid of
uterus were more frequent among WWE. Careful planning and
management of pregnancy in WWE improve the outcome for the
mother and infant.
Acknowledgement
This study was carried out with grant in aid from the Indian
Council of Medical Research, Kerala Council for Science, Technol-
ogy and Environment and Indian Epilepsy Society.
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