Interruption of a study of cervical ripening with isosorbide mononitrate due to adverse effects.
OBJECTIVE
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 Three patients requested that they be withdrawn.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.
Department of Obstetrics, Federal University of São Paulo, São Paulo, SP, Brazil. alahatanaka@alahatanaka.com.br
A R
AR
Hatanaka
A F
AF
Moron
M M
MM
Auxiliadora de Aquino
E
E
de Souza
L C
LC
de Silva Bussamra
E
E
Araujo Júnior
R
R
Mattar
D000282:Administration, Intravaginal; D000328:Adult; D015148:Cardiotocography; D020070:Cervical Ripening / Q000187:drug effects*; D002584:Cervix Uteri / Q000000981:diagnostic imaging / Q000187:drug effects; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D007548:Isosorbide Dinitrate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D007751:Labor, Induced; D020030:Nitric Oxide Donors / Q000008:administration & dosage / Q000009:adverse effects*; D017060:Patient Satisfaction; D010865:Pilot Projects; D011247:Pregnancy; D011256:Pregnancy Outcome; D011263:Pregnancy Trimester, Third; D016216:Ultrasonography, Prenatal; D055815:Young Adult
D020030:Nitric Oxide Donors; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate