Document Detail

Interruption of a study of cervical ripening with isosorbide mononitrate due to adverse effects.
MedLine Citation:
PMID:  22905458     Owner:  NLM     Status:  MEDLINE    
PURPOSE OF INVESTIGATION: The objective of this study was to evaluate cervix length and the presence of cervical gland area (CGA) in ultrasounds performed before and after the administration of vaginal isosorbide mononitrate (IMN) for cervical ripening.
METHODS: We performed an observational, descriptive, and longitudinal study of pregnant patients indicated for labor induction and with a Modified Bishop Score (MBS) lower than six. For cervical ripening, 40 mg of vaginal IMN was administered at 0, 16, and 24 hours after the initiation of cervix preparation.
RESULTS: After enrolling 11 patients, the study had to be discontinued due to adverse effects. Three patients requested that they be withdrawn. Headaches were reported by all patients. Nausea, dizziness, dyspnea, and vomiting were also reported. The average cervical lengths at 0, 16, 24 and 36 hours were 27.6, 27.7, 25.9, and 23.0 mm, respectively. CGA disappeared in one of seven patients.
CONCLUSIONS: The use of IMN appears to increase the MBS, slightly reducing cervical length without altering the appearance of CGA. Considering the importance of maternal wellbeing during labor, the routine use of IMN cannot be recommended for cervical ripening in the third trimester due to the frequency and intensity of side-effects.
A R Hatanaka; A F Moron; M M Auxiliadora de Aquino; E de Souza; L C de Silva Bussamra; E Araujo Júnior; R Mattar
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  Clinical and experimental obstetrics & gynecology     Volume:  39     ISSN:  0390-6663     ISO Abbreviation:  Clin Exp Obstet Gynecol     Publication Date:  2012  
Date Detail:
Created Date:  2012-08-21     Completed Date:  2012-09-11     Revised Date:  2012-09-20    
Medline Journal Info:
Nlm Unique ID:  7802110     Medline TA:  Clin Exp Obstet Gynecol     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  175-80     Citation Subset:  IM    
Department of Obstetrics, Federal University of São Paulo, São Paulo, SP, Brazil.
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MeSH Terms
Administration, Intravaginal
Cervical Ripening / drug effects*
Cervix Uteri / drug effects,  ultrasonography
Early Termination of Clinical Trials
Isosorbide Dinitrate / administration & dosage,  adverse effects,  analogs & derivatives*
Labor, Induced
Nitric Oxide Donors / administration & dosage,  adverse effects*
Patient Satisfaction
Pilot Projects
Pregnancy Outcome
Pregnancy Trimester, Third
Ultrasonography, Prenatal
Young Adult
Reg. No./Substance:
0/Nitric Oxide Donors; 16051-77-7/isosorbide-5-mononitrate; 87-33-2/Isosorbide Dinitrate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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