Multicenter trial for induction of labor with the combination of misoprostol and mechanical ripening of the cervix

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: Combination of OM and mechanical dilation with a double‐balloon catheter for cervical ripening (COOK CRB) is used. Each participating hospital uses its own misoprostol regime plus CRB for a maximum of 12 hours the first day. e.g. the regime of the primary study unit: First day: OM 50 microg with repeat doses 4 and 8 hours later if necessary plus CRB for a maximum of 12 hours Second day: OM 100 microg with repeat doses 4 and 8 hours later if necessary Third day: misoprostol 50 microg vaginally with repeat doses 4 and 8 hours later if necessary CONDITION: Efficacy of two different methods of labor induction at term ‐ OM and Cook CRB versus OM alone. PRIMARY OUTCOME: The rate of failure to induce labor, defined as no delivery within 48 hours. SECONDARY OUTCOME: The time of induction of labor to birth. INCLUSION CRITERIA: singleton pregnancy at term greater than 259 days of gestation, vertex presentation, indication for induction of labor, and an unfavorable cervix (Bishop score < 8)
Epistemonikos ID: b3f3e198728dff44926b7344857fefa260c0d181
First added on: Aug 22, 2024