lamotrigine and Cleft Palate, Isolated studies

Research Excerpts

Excerpt	Relevance	Reference
"To assess the relative risk of oral clefts associated with maternal use of high and low doses of topiramate during the first trimester for epilepsy and nonepilepsy indications."	7.88	Topiramate use early in pregnancy and the risk of oral clefts: A pregnancy cohort study. ( Bateman, BT; Cohen, JM; Desai, RJ; Hernandez-Diaz, S; Huybrechts, KF; Mogun, H; Patorno, E; Pennell, PB, 2018)
"The infant exposed in the first trimester of pregnancy to the anticonvulsant drug lamotrigine has an increased risk to have an isolated cleft palate or cleft lip deformity."	7.74	Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy. ( Baldwin, EJ; Glassman, L; Habecker, E; Holmes, LB; Smith, CR; Wong, SL; Wyszynski, DF, 2008)
" The mother had been treated with valproic acid (1800mg per day) and lamotrigine (100mg per day) throughout pregnancy."	7.72	Valproic acid and lamotrigine treatment during pregnancy. The risk of chromosomal abnormality. ( Cogulu, O; Gunduz, C; Kultursay, N; Ozkinay, F; Yilmaz, D, 2003)
"To assess the relative risk of oral clefts associated with maternal use of high and low doses of topiramate during the first trimester for epilepsy and nonepilepsy indications."	3.88	Topiramate use early in pregnancy and the risk of oral clefts: A pregnancy cohort study. ( Bateman, BT; Cohen, JM; Desai, RJ; Hernandez-Diaz, S; Huybrechts, KF; Mogun, H; Patorno, E; Pennell, PB, 2018)
"One of my female patients has epilepsy and is currently receiving lamotrigine monotherapy."	3.74	Teratogenicity of lamotrigine. ( Koren, G; Nulman, I; Shor, S, 2007)
"The infant exposed in the first trimester of pregnancy to the anticonvulsant drug lamotrigine has an increased risk to have an isolated cleft palate or cleft lip deformity."	3.74	Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy. ( Baldwin, EJ; Glassman, L; Habecker, E; Holmes, LB; Smith, CR; Wong, SL; Wyszynski, DF, 2008)
" The mother had been treated with valproic acid (1800mg per day) and lamotrigine (100mg per day) throughout pregnancy."	3.72	Valproic acid and lamotrigine treatment during pregnancy. The risk of chromosomal abnormality. ( Cogulu, O; Gunduz, C; Kultursay, N; Ozkinay, F; Yilmaz, D, 2003)

Research

Studies (7)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	4 (57.14)	29.6817
2010's	3 (42.86)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Hernandez-Diaz, S	2
Huybrechts, KF	1
Desai, RJ	1
Cohen, JM	1
Mogun, H	1
Pennell, PB	1
Bateman, BT	1
Patorno, E	1
Dolk, H	1
Wang, H	1
Loane, M	1
Morris, J	1
Garne, E	1
Addor, MC	1
Arriola, L	1
Bakker, M	1
Barisic, I	1
Doray, B	1
Gatt, M	1
Kallen, K	1
Khoshnood, B	1
Klungsoyr, K	1
Lahesmaa-Korpinen, AM	1
Latos-Bielenska, A	1
Mejnartowicz, JP	1
Nelen, V	1
Neville, A	1
O'Mahony, M	1
Pierini, A	1
Rißmann, A	1
Tucker, D	1
Wellesley, D	1
Wiesel, A	1
de Jong-van den Berg, LT	1
Hunt, SJ	1
Craig, JJ	1
Morrow, JI	1
Holmes, LB	2
Ozkinay, F	1
Cogulu, O	1
Gunduz, C	1
Yilmaz, D	1
Kultursay, N	1
Shor, S	1
Koren, G	1
Nulman, I	1
Baldwin, EJ	1
Smith, CR	1
Habecker, E	1
Glassman, L	1
Wong, SL	1
Wyszynski, DF	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum[NCT02163434]	Phase 2	31 participants (Actual)	Interventional	2014-06-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Score range: 6-30 with higher score indicating a worse outcome. (NCT02163434)
Timeframe: 1 week

Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.

Intervention	units on a scale (Mean)
Gabapentin	6.35
Metoclopramide	13.22

Score range: 2-10 with higher score indicating a worse outcome. (NCT02163434)
Timeframe: 1 week

Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7

Intervention	units on a scale (Mean)
Gabapentin	2.01
Metoclopramide	3.69

Score range: 0-15 with higher score indicating a better outcome. (NCT02163434)
Timeframe: 1 week

Desire to Continue Therapy at Study Endpoint

Intervention	units on a scale (Mean)
Gabapentin	7.86
Metoclopramide	4.01

Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome. (NCT02163434)
Timeframe: 1 week

Global Satisfaction of Treatment at the Study Endpoint.

Intervention	units on a scale (Mean)
Gabapentin	0.67
Metoclopramide	0.14

Score range: 0-4 with higher score indicating a better outcome. (NCT02163434)
Timeframe: 1 week

Article	Year
Topiramate use early in pregnancy and the risk of oral clefts: A pregnancy cohort study. Neurology, 2018, 01-23, Volume: 90, Issue:4 Topics: Abnormalities, Drug-Induced; Adult; Anticonvulsants; Cleft Palate; Cohort Studies; Dose-Response Rel	2018
Lamotrigine use in pregnancy and risk of orofacial cleft and other congenital anomalies. Neurology, 2016, 05-03, Volume: 86, Issue:18 Topics: Abnormalities, Drug-Induced; Adult; Anticonvulsants; Case-Control Studies; Cleft Lip; Cleft Palate;	2016
Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy. Neurology, 2009, Mar-24, Volume: 72, Issue:12 Topics: Adult; Anticonvulsants; Bias; Cleft Palate; Cohort Studies; Female; Humans; Incidence; Infant, Newbo	2009
Newer anticonvulsants: lamotrigine, topiramate and gabapentin. Birth defects research. Part A, Clinical and molecular teratology, 2012, Volume: 94, Issue:8 Topics: Abnormalities, Drug-Induced; Adult; Amines; Anticonvulsants; Case-Control Studies; Child; Child, Pre	2012
Valproic acid and lamotrigine treatment during pregnancy. The risk of chromosomal abnormality. Mutation research, 2003, Jan-10, Volume: 534, Issue:1-2 Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Adult; Anticonvulsants; Chromosome Aberrations	2003
Teratogenicity of lamotrigine. Canadian family physician Medecin de famille canadien, 2007, Volume: 53, Issue:6 Topics: Abnormalities, Drug-Induced; Anticonvulsants; Cleft Palate; Drug Evaluation; Epilepsy; Female; Human	2007
Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy. Neurology, 2008, May-27, Volume: 70, Issue:22 Pt 2 Topics: Abnormalities, Drug-Induced; Anticonvulsants; Cleft Palate; Epilepsy; Female; Humans; Infant; Infant	2008

lamotrigine and Cleft Palate, Isolated