Diazepam at the Active Phase of Labor

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

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 Overview

• Status: Unknown
• Conditions: Pain; Prolonged Labour
• Intervention / Treatment: Drug: normal saline/diazepam at the active phase of labor

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100048
      • Navy General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: normal saline, active phase of labor; 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; A single dose intravenous injection of normal saline (2ml)/diazepam (10mg, 2ml) at the beginning of active phase of labor.
Experimental: diazepam, active phase of labor; 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; A single dose intravenous injection of normal saline (2ml)/diazepam (10mg, 2ml) at the beginning of active phase of labor.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Maternal adverse events	two weeks after childbirth
Neonatal adverse events	two weeks after childbirth
Maternal satisfaction	post partum, immediately

Collaborators and Investigators

• Sponsor: Navy General Hospital, Beijing
• Investigators: Principal Investigator: Aiming Wang, Dr, Navy General Hospital, Beijing

Publications and helpful links

General Publications

• Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009243. doi: 10.1002/14651858.CD009243.pub3.
• Othman M, Jones L, Neilson JP. Non-opioid drugs for pain management in labour. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009223. doi: 10.1002/14651858.CD009223.pub2.
• Davies JM, Rosen M. Intramuscular diazepam in labour. A double-blind trial in multiparae. Br J Anaesth. 1977 Jun;49(6):601-4. doi: 10.1093/bja/49.6.601.
• Friedman EA, Niswander KR, Sachtleben MR. Effect of diazepam on labor. Obstet Gynecol. 1969 Jul;34(1):82-6. No abstract available.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: August 30, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Estimate): September 4, 2014
• Last Update Submitted That Met QC Criteria: September 3, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: diazepam; active phase
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: chuaiyunhai-002