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IRCT201503037974N7 IRCT 2015-06-28 Nabiqasim Industries (Pvt) Ltd. In vivo performance of two commercial products of dinoprostone vaginal tablet and safety study of Kleen enema. DINO (V.T) BE003 In vivo performance of two commercial products of dinoprostone vaginal tablets and safety study of phosphate enema in pregnant women. 2014-03-20 anticipated 90 Complete https://irct.ir/trial/8404 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: this is a single blind, two arm, parallel, randomized control study for dinoprostone. While for Kleen enema it is a single arm non-randomize study. 2-3 Pregnancy, childbirth and the puerperium. Intervention 1: Dinoprostone 3mg vaginal tablet (Test Product: Glandin E2). a dose of 3mg vaginal tablet was inserted high into posterior fornix a second dose was given in some patients (if required & prescribed by doctor) after six hours. And a single dose of Kleen Enema 120 ml was given rectally before dinoprostone doing. Intervention 2: Dinoprostone 3mg vaginal tablet (Reference Product: Prostin E2). a dose of 3mg vaginal tablet was inserted high into posterior fornix a second dose was given in some patients (if required & prescribed by doctor) after six hours. And a single dose of Kleen Enema 120 ml was given rectally before dinoprostone doing.
public Mr. Salman A. Rahim
510, 5th floor, commerce center, Hasrat Mohani Road
Karachi Pakistan 74200 00922132636919 salman.rahim@nabiqasim.com Nabiqasim Industries (Pvt) Ltd. scientific Dr. Haleema Yasmin
Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road
Karachi Pakistan 75510 00922199201300 dr.haleemayasmin@yahoo.com Department of Gynae and obstt at Jinnah postgraduate medical center Pakistan Inclussion Criteria: pregnant women at or near term gestation (≥ 37 weeks) with a medical or obstetrical indication for the induction of labor; Age: 18-35 years; singleton pregnancy with cephalic presentation; parity ≤ 3; intact membrane; bishop score less than or equal to 4; fetal reactive non-stress test. Exclusion criteria: neuropathy; renal impairment; liver disease; diabetes; hypertension & CV disease; placenta previa; placental abruption; vasa previa; active herpes genitalia; spontaneous labour; fetal death in-utero; where oxytocic drugs are contraindicated or where prolong contractions of uterus are considered inappropriate. kleen enema will not be administered if subject is with diarrhoea & vomiting . 18 years 35 years Female XV The codes included in this chapter are to be used for conditions related to or aggravated by the pregnancy, childbirth or by the puerperium (maternal causes or obstetric causes) Treatment - Drugs Treatment - Drugs Dinoprostone 3mg vaginal tablet (Test Product: Glandin E2). a dose of 3mg vaginal tablet was inserted high into posterior fornix a second dose was given in some patients (if required & prescribed by doctor) after six hours. And a single dose of Kleen Enema 120 ml was given rectally before dinoprostone doing. Dinoprostone 3mg vaginal tablet (Reference Product: Prostin E2). a dose of 3mg vaginal tablet was inserted high into posterior fornix a second dose was given in some patients (if required & prescribed by doctor) after six hours. And a single dose of Kleen Enema 120 ml was given rectally before dinoprostone doing. Cervical dilatation i.e. an increase of 3 in bishop from baseline. Timepoint: At six hours and 12 hours after dosing. Method of measurement: Bishop scoring. Cervical dilatation i.e. Attainment of bishop score of 6 or more. Timepoint: At six hours and 12 hours after dosing. Method of measurement: Bishop scoring. Vaginal delivery. Timepoint: Vaginal delivery occurring within 12 hours of dinoprostone dosing. Method of measurement: through Observation. Kleen enema Adverse events. Timepoint: within half an hour after Kleen Enema dosing (before Dinoprostone Vaginal dosing). Method of measurement: Adverse event monitoring by subject monitoring. Maternal adverse events. Timepoint: after dosing till delivery for dinoprostone. and after phosphate enema dosing till before the dosing of dinoprostone. Method of measurement: through adverse event monitoring. Fetal Adverse events. Timepoint: After Dinoprostone vaginal tablet dosing till delivery. Method of measurement: CTG & obstetrical examination. Neonatal adverse events. Timepoint: Just after birth at 1 & 5 minutes. Method of measurement: APGAR score. U1111-1167-6717 WHO Nabiqasim Industries (Pvt) Ltd. Approved 2014-02-15 Ethics committee of Jinnah Postgraduate Medical Center Jinnah Postgraduate Medical Center, Rafique Shaheed Road Karachi Sindh Pakistan