MARC details
000 -LEADER |
fixed length control field |
04193nam a22007457a 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
160204s20152015 xxu||||| |||| 00| 0 eng d |
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
International Standard Serial Number |
1471-2393 |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
Ovid MEDLINE(R) |
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
PMID |
25884778 |
245 ## - TITLE STATEMENT |
Title |
Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. |
251 ## - Source |
Source |
BMC Pregnancy & Childbirth. 15:59, 2015. |
252 ## - Abbreviated Source |
Abbreviated source |
BMC Pregnancy Childbirth. 15:59, 2015. |
253 ## - Journal Name |
Journal name |
BMC pregnancy and childbirth |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Year |
2015 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Manufacturer |
FY2016 |
266 ## - Date added to catalog |
Date added to catalog |
2016-05-24 |
501 ## - WITH NOTE |
Local holdings |
Available online from MWHC library: 2001 - present |
520 ## - SUMMARY, ETC. |
Abstract |
BACKGROUND: Nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 80% of expecting mothers. In April 2013 the FDA approved the delayed release combination of doxylamine succinate and -pyridoxine hydrochloride (Diclegis) for NVP, following a phase 3 randomized trial in pregnant women. The fetal safety of this medication has been proven by numerous studies. However, because it is the only FDA-approved medication for NVP that is likely to be used by a large number of pregnant women, its maternal safety is an important public health question. The Objective is to evaluate the maternal safety of doxylamine succinate -pyridoxine hydrochloride delayed-release preparation (Diclegis as compared to placebo. |
520 ## - SUMMARY, ETC. |
Abstract |
CONCLUSIONS: Doxylamine succinate-pyridoxine hydrochloride delayed release combination is safe and well tolerated by pregnant women when used in the recommended dose of up to 4 tablets daily in treating nausea and vomiting of pregnancy. |
520 ## - SUMMARY, ETC. |
Abstract |
METHODS: We randomized women suffering from NVP to receive Diclegis (n=131) or placebo (n=125) for 14 days at doses ranging from 2-4 tablets a day, based on a pre-specified titration protocol response to symptoms. Adverse events were collected through patient diaries, clinical examination and laboratory testing. |
520 ## - SUMMARY, ETC. |
Abstract |
RESULTS: Doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg use was not associated with an increased rate of any adverse event over placebo, including CNS depression, gastrointestinal or cardiovascular involvement. |
520 ## - SUMMARY, ETC. |
Abstract |
TRIAL REGISTRATION: Clinical Trial Registration No: NCT00614445 . |
546 ## - LANGUAGE NOTE |
Language note |
English |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Dicyclomine |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Doxylamine |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Nausea |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Pregnancy Complications/dt [Drug Therapy] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Pyridoxine |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Vomiting |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Adult |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Antiemetics/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Antiemetics/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Delayed-Action Preparations/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Delayed-Action Preparations/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Dicyclomine/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Dicyclomine/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Double-Blind Method |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Doxylamine/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Doxylamine/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Drug Combinations |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Drug Monitoring/mt [Methods] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Female |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Histamine H1 Antagonists/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Histamine H1 Antagonists/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Humans |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Nausea/dt [Drug Therapy] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Nausea/et [Etiology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Pregnancy |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Pyridoxine/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Pyridoxine/ae [Adverse Effects] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Treatment Outcome |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Vitamin B Complex |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Vomiting/dt [Drug Therapy] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Vomiting/et [Etiology] |
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
Institution |
MedStar Health Research Institute |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Journal Article |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Multicenter Study |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Randomized Controlled Trial |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Research Support, Non-U.S. Gov't |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Miodovnik, Menachem |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Umans, Jason G |
790 ## - Authors |
All authors |
Caritis SN, Clark S, Hankins GD, Koren G, Matok I, Mattison DR, Miodovnik M, Umans JG |
856 ## - ELECTRONIC LOCATION AND ACCESS |
DOI |
<a href="http://dx.doi.org/10.1186/s12884-015-0488-1">http://dx.doi.org/10.1186/s12884-015-0488-1</a> |
Public note |
http://dx.doi.org/10.1186/s12884-015-0488-1 |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Journal Article |
Item type description |
Article |