Diazepam at the Active Phase of Labor

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Navy General Hospital, Beijing
• Treatments: Diazepam

Criteria

Inclusion Criteria:

• primigravida

• at term

• singleton pregnancy

• cephalic presentation

• spontaneous labour

• intact membranes at the beginning of active phase

Exclusion Criteria:

• induced labour

• spontaneous rupture of membranes at randomisation

• obstetric complications, or medical complications

• previous uterine scarring, or cervical surgery

• cervical dilatation of more than 5 cm

• other antispasmodics in the first stage

• malpresentation, macrosomia, cephalopelvic disproportion