Diazepam at the Active Phase of Labor

Navy General Hospital, Beijing

Status and phase: Unknown; Phase 2

Conditions: Prolonged Labour; Pain

Treatments: Drug: normal saline/diazepam at the active phase of labor

Study type: Interventional

Funder types: Other

Identifiers

NCT02232035

chuaiyunhai-002

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

normal saline, active phase of labor

Placebo Comparator group

Description:

A single dose intravenous injection of normal saline (2ml) at the beginning of active phase of labor in the group.

Treatment:

Drug: normal saline/diazepam at the active phase of labor

diazepam, active phase of labor

Experimental group

Description:

A single dose intravenous injection of diazepam (10mg, 2ml) at the beginning of active phase of labor in the group.

Treatment:

Drug: normal saline/diazepam at the active phase of labor