COMPARISON OF THE EFFICACY OF PROSTAGLANDIN E2 VAGINAL TABLET VERSUS GEL FOR THE INDUCTION OF LABOR AT TERM: A RANDOMIZED CONTROLLED TRIAL
Abstract
Background: Prostaglandin E2 in different forms has been widely used for induction of labor in women with an unfavorable cervix. No significant differences have been noticed between prostaglandin E2 tablets versus gel for induction. The aim of this study was to compare vaginal prostaglandin E2 tablet of 3mg with an increased dose of gel i.e 2mg given both to primigravidas, multigravidas as well as grand multigravidas, regarding any differences in mode of delivery, induction delivery interval and any adverse maternal and fetal outcomes.
Materials & Methods: A randomized control trial was conducted at the department of Gynecology and Obstetrics of Qazi Hussain Ahmad medical complex over 6-month period from July to December 2021. One hundred and seventy-nine women, who met the inclusion and exclusion criteria, were randomly divided into two groups. Patients in group A were induced with Prostaglandin E2 tablet of 3mg and those in group B received vaginal gel of 2mg. Drug was kept in posterior fornix of vagina at 6 hourly intervals with pre and post induction CTG and fetal heart rate recorded. A maximum of 2 doses of each formulation was given. Primary outcome measures were mode of delivery and induction delivery interval. Secondary outcome includes adverse maternal and fetal outcomes, in terms of postpartum hemorrhage, uterine hyper stimulation and fetal distress.A structured questionnaire was used to collect the relevant information of the patient. After data collection and analysis by using MS Office & SPSS 20, the results were finally presented in tables & figures.
Results: One hundred and seventy-nine women were randomly divided into two groups. Among both groups, no difference was found between modes of delivery i.e. normal vaginal deliveries and c section with increasing parity. Also it was found that parity has no significant impact with respect to the number of doses required of each formulation for inducing labor and modes of delivery with a P-value (0.136 & 0.583) and (0.421 & 0.123) between single and double dose of tablet and gel and among the patients delivered by NVD and C-section respectively. However, a statistically significant difference was found in induction delivery interval with a p-value of 0.02 &0.001 respectively between parity and time duration (≤12hrs & >12hrs). A consistent result was found between both formulations for adverse maternal and fetal outcomes in terms of fetal distress, postpartum hemorrhage and uterine hyper stimulation respectively.
Conclusion: We have concluded that Primi and multi gravidas are more likely to have a shorter induction delivery interval i.e. ≤ 12 hours in the group A versus the group B while grand multigravidas are more likely to have a shorter induction delivery interval with the gel. However, no significant differences in the number of doses, mode of delivery and adverse maternal and fetal outcomes was found between the two groups.
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DOI: https://doi.org/10.46903/gjms/21.04.1304
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