A trial to see which form of the drug Misoprostol used for induction of labour is more effective and safer- in fluid form given at regular intervals starting at low dose or as a tablet with fixed dose

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Titrated oral Misoprostol Solution: Titrated oral Misoprostol Solution given hourly for 6 hours and maximum 7 doses following induction with Mifepristone and Foley EASI Control Intervention1: Oral misoprostol tablet: Oral misoprostol tablet 50 mcg given at 2 hourly intervals for 6 hours and maximum 4 doses folllowing induction with Mifepristone and Foley EASI CONDITION: Health Condition 1: O80‐ Encounter for full‐term uncomplicated delivery PRIMARY OUTCOME: 1. To compare the induction delivery interval in both arms ; 2. To compare the caesarean delivery rate in both armsTimepoint: Time period from the start of induction of labour to the delivery of the patient SECONDARY OUTCOME: 1. To compare the need for Oxytocin augmentation in Titrated Oral Misoprostol Solution and Oral Misoprostol Tablet in both arms ; 2. To compare the incidence of Tachysystole in both arms ; 3. To compare the occurrence of meconium stained amniotic fluid in both arms ; 4. To compare the non‐reassuring Fetal Heart Rate(FHR) tracing in both arms ; 5. To know the number of NICU admissions in both arms ; 6. To compare the number of patients with adverse drug reaction to Misoprostol in both armsTimepoint: Time period from the start of induction of labour to the delivery of the patient INCLUSION CRITERIA: 1. primigravida 2. 37‐40 weeks of pregnancy 3. singleton pregnancy with cephalic presentation 4. no uterine scar 5. Bishop score less than or equal to 6
Epistemonikos ID: 5548a4fe7bae06310c951f62e3b9c5cc61405a50
First added on: Feb 20, 2024