Adverse Drug Reaction with Hyoscine and Valethamate for Cervical Dilation during Labour

Abstract

 Adverse drug reaction (ADR) is an injury caused by taking medication. ADR may occur following single dose or prolong administration of drug or combination of two or more drugs. While major advancements of discipline of pharmacovigilance have taken place in the West, not much has been achieved in Asian countries. Labour is characterised by forceful and painful uterine contraction that result in cervical dilation and foetus decent from the birth canal. Anti-spasmodic drugs like hyoscine butylbromide and valethamate bromide have been used to accelerate cervical dilation and thus reduce the labor duration. The objective was to observe ADR with hyoscine and valethamate for cervical dilation during labor. It was a hospital based cross sectional study. Investigation was carried out in the form of questionnaire. All the consecutive patients who were in active stage of labor were included in the study. They were given Intravenous (IV) valethamate bromide 8mg and hyoscine butylbromide 20mg, 3 doses half an hour apart. After administration of the drug, the progress of labor was monitored and management was done as per protocol in obstetrics and gynaecology department. ADR reported were blurred vision in 47.7% of the patients, followed by dry mouth (36.9%) and tachycardia (19.2%). Other ADRs were nausea (6.2%), dizziness (3.8%), flushing (2.3%), vomiting (1.5%), fever (1.5%) and constipation (1.5%). No statistical significance was found when ADR was compared between the age group of 18-25 years and 26-35 years. Therefore, ADR reported were irrespective of the age of the patients and no life threatening or severe forms of ADR were seen with hyoscine and valethamate during cervical dilation.