Diazepam at the Active Phase of Labor

Study Overview
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Brief Summary
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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.

Official Title
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Intravenous Injection of Diazepam at the Beginning of Active Phase of Labor

Conditions
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Pain, Prolonged Labour

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normal saline, active phase of labor<br>A single dose intravenous injection of normal saline (2ml) at the beginning of active phase of labor in the group. | Drug: normal saline/diazepam at the active phase of labor<br>* A single dose intravenous injection of normal saline (2ml)/diazepam (10mg, 2ml) at the beginning of active phase of labor.<br>|
| Experimental: diazepam, active phase of labor<br>A single dose intravenous injection of diazepam (10mg, 2ml) at the beginning of active phase of labor in the group. | Drug: normal saline/diazepam at the active phase of labor<br>* A single dose intravenous injection of normal saline (2ml)/diazepam (10mg, 2ml) at the beginning of active phase of labor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cervical dilatation |  | 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.) | every 30 minutes during the 3-hour period after administration of the trial drug | 
| Type of delivery |  | post partum, immediately | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diazepam, active phase