Pregnancy, childbirth and the puerperium. 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)
Conditions
Interventions
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
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
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 & prescribe
Sponsors
Nabiqasim Industries (Pvt) Ltd.
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 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 .
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Pakistan
Contacts
Public ContactMr. Salman A. Rahim
Nabiqasim Industries (Pvt) Ltd.
Outcome results
None listed