Safety and effectiveness of dinoprostone vaginal gel in pregnant women.
Phase 4
- Conditions
- 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)
- Registration Number
- IRCT201502187974N6
- Lead Sponsor
- abiqasim Industries (Pvt) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 45
Inclusion Criteria
Inclusion Criteria: Pregnant women; scheduled for labor induction with 2mg Dinoprostone vaginal gel; bishop score less than or equal to 4.
Exclusion criteria: Bishop score greater then 4.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase of 3 in bishop score. Timepoint: six hours and 12 hours after dosing. Method of measurement: Bishop scoring method.;Attainment of bishop score of 6 or more. Timepoint: six and 12 hours after dosing. Method of measurement: Bishop scoring method.;Vaginal delivery occurring within 12 hours of dosing. Timepoint: occurring within 12 hours of dosing. Method of measurement: subject monitoring.
- Secondary Outcome Measures
Name Time Method Maternal adverse events. Timepoint: from dosing to delivery. Method of measurement: Patient monitoring.;Neonatal adverse events. Timepoint: just after birth at 1 & 5 minutes. Method of measurement: APGAR score.;Fetal Adverse events. Timepoint: two hours after dosing, at six & 12 hours after dosing (till baby is not delivered). Method of measurement: by measuring CTG.