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document
Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2 : a randomized , double-blind , placebo-controlled trial . OBJECTIVE Our purpose was to determine whether a protocol for outpatient induction is safe and effective for initiating labor . STUDY DESIGN A randomized , double-blind , placebo-controlled trial was performed with 100 low-risk patients having well-dated pregnancies . Women with a Bishop score < or = 6 at 38 to 40 weeks ' gestation were administered either 2 mg of intravaginal prostaglandin E2 gel or placebo for 5 consecutive days as outpatients while undergoing fetal monitoring . RESULTS The median interval from randomization to delivery was 4 days in the prostaglandin E2 group ( range 0 to 28 days ) versus 10 days in the placebo group ( range 0 to 26 days , p = 0.002 ) . Twenty-seven of 50 patients ( 54 % ) in the prostaglandin E2 group were admitted for labor during the dosing interval compared with 10 placebo-treated patients ( 20 % , p = 0.001 ) . The mean gestational age at delivery was significantly reduced in the treatment group ( 39.9 +/- 1.0 weeks vs 40.5 +/- 0.99 weeks , p = 0.003 ) as was the incidence of postdates pregnancy ( 40 % vs 66 % , p = 0.016 ) . Hyperstimulation was observed in one prostaglandin E2-treated patient , but no intervention was required . CONCLUSIONS Outpatient low-dose prostaglandin E2 gel administration is effective for initiating labor in patients with an unfavorable cervix and appears safe if performed with adequate monitoring .
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Intervention_Pharmacological
prostaglandin E2 :
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Intervention_Control
placebo-controlled
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
intravaginal prostaglandin E2 gel or placebo
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Intervention_Pharmacological
prostaglandin E2
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Intervention_Control
placebo
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Intervention_Pharmacological
prostaglandin E2
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Intervention_Pharmacological
prostaglandin E2-treated
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Intervention_Pharmacological
prostaglandin E2 gel
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Outcome_Other
Efficacy
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Outcome_Mental
interval from randomization to delivery
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Outcome_Other
admitted for labor during the dosing interval
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Outcome_Physical
mean gestational age at delivery
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Outcome_Mental
incidence of postdates pregnancy
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Outcome_Other
Hyperstimulation
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Outcome_Mental
effective
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Outcome_Other
initiating labor
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Participant_Sample-size
100
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Participant_Condition
pregnancies
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Participant_Condition
Bishop score < or = 6
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Participant_Condition
38 to 40 weeks ' gestation
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Participant_Sample-size
50
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Participant_Condition
unfavorable cervix