Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. (Record no. 1718)

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
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 05/24/2016   25884778 25884778 05/24/2016 05/24/2016 Journal Article

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