Diazepam at the Active Phase of Labor

Phase 2UnknownNCT02232035

Navy General Hospital, Beijing400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

400

Conditions

Pain Prolonged Labour

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Duration of labor

Duration of first stage of labor. Duration of second stage of labour. Duration of third stage of labor. Total duration of labor.

Time frame: labor

Secondary Outcomes

Rate of cervical dilatation

Time frame: at the active phase of labor

Pain relief

Pain severity during the last contraction was assessed using a Visual Analogue Scale (VAS) (with anchor points of 0 = no pain at all and 10 = the most excruciating pain) every 30 minutes during the 3-hour period after administration of the trial drug. This information was used to derive measures of pain relief at each time-point using absolute change in pain intensity (on a 10-cm VAS) from pre-analgesia (baseline). In addition to analysing all the time-points together (as described in the section on statistical analysis), a specific analysis of pain relief at 60 minutes was conducted, because it was anticipated that the maximum analgesic effect would occur then. (Wee MYK, Tuckey JP, Thomas PW, Burnard S. A comparison of intramuscular diamorphine and intramuscular pethidine for labour analgesia: a two-centre randomised blinded controlled trial. BJOG 2014;121:447-456.)

Time frame: every 30 minutes during the 3-hour period after administration of the trial drug

Type of delivery

Time frame: post partum, immediately