drugset / Trial / NCT02232035

Diazepam at the Active Phase of Labor

NCT02232035

Phase 2 Unknown 400 enrolled Navy General Hospital, Beijing
RandomizedParallel-groupTriple-blindPrevention

Summary

Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and asphyxia and requires early detection and appropriate clinical response. The risks for complications of prolonged labour are much greater in poor resource settings. Active management of labour versus physiological, expectant management, has shown to decrease the occurrence of prolonged labour. Administering sedatives during labour could also lead to faster and more effective dilatation of the cervix. Interventions to shorten labour, such as sedatives, can be used as a preventative or a treatment strategy in order to decrease the incidence of prolonged labour. As the evidence to support this is still largely anecdotal around the world. (Cochrane Database of Systematic Reviews 2013,CD009243.pub3.; Cochrane Database of Systematic Reviews 2012, CD009223.pub2.) Hypothesis: Diazepam reduced the duration of labor and the severity of pain in labor.

Timeline

Start
2014-09
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Diazepam Small molecule 10 mg Intravenous

Indications