A randomized clinical trial comparing intravaginal glyceryl trinitrate (nitric oxide donor) plus artificial sweeping of membrane versus artificial sweeping of membrane alone for cervical ripening at term pregnancies with unfavourable cervix

Introduction Significant amount of pregnant mothers is not undergoing spontaneous onset of labour at term. The policy of cervical ripening at term will reduce the risk and their complications associated with post date pregnancies. Artificial sweeping of membranes and nitric oxide donors are useful cervical ripening methods used across the world. This study was carried out to compare the efficacy of cervical ripening by administration of intravaginal Glyceryltrinitrate plus artificial sweeping of membranes versus artificial sweeping of membranes alone. Objectives To Compare of the efficacy,the spontaneous onset of labour rate, the labour outcome, the duration from induction to the delivery time of baby and adverse maternal and fetal outcomes of cervical ripening by administrating of intravaginal Glyceryltrinitrate combined with artificial sweeping of membranes versus artificial sweeping of membranes alone. Methodology This was a double blinded randomized clinical trial carried out in a major obstetric unit in Sri Lanka.Having excluded the subjects according to the exclusion criteria, rest of the sample was divided into cases and controls. Sample size was calculated as 114 for each arm. Approval of the proposal and ethical clearance have been obtained from the board of study and ethical review committee of postgraduate institute of medicine, University of Colombo, SriLanka respectively.Sample randomization done by using stratified block randomization technique with sealed envelope. Information leaflet was given and detailed written consent was taken from the subjects prior to the recruitment. Artificial sweeping of membranes together with intravaginal Glycery ltrinitrate was inserted for the cases and artificial sweeping of membranes alone was performed for the control group. Spontaneous onset of labour, improvement of the modified Bishop’s Score and labor outcome were assessed. Data were analyzed by using SPSS software. Results Mean age, parity and gestational age were matched in both intervention and control group. Results were analyzed by SPSS software using standard statistical tools. Spontaneous onset of labour within 24 hours were significantly increased (p