Diazepam at the Active Phase of Labor

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.

Full Title of Study: “Intravenous Injection of Diazepam at the Beginning of Active Phase of Labor”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: September 2015

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Duration of labor
    • Time Frame: labor
    • Duration of first stage of labor. Duration of second stage of labour. Duration of third stage of labor. Total duration of labor.

Secondary Measures

  • Rate of cervical dilatation
    • Time Frame: at the active phase of labor
  • Pain relief
    • Time Frame: every 30 minutes during the 3-hour period after administration of the trial drug
    • 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.)
  • Type of delivery
    • Time Frame: post partum, immediately

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Navy General Hospital, Beijing
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yunhai Chuai, Department of Obstetrics and Gynecology, Navy General Hospital, Beijing – Navy General Hospital, Beijing
  • Overall Official(s)
    • Aiming Wang, Dr, Principal Investigator, Navy General Hospital, Beijing
  • Overall Contact(s)
    • Yunhai Chuai, Dr, +86-18810892004, wangyh85@foxmail.com

References

Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;(6):CD009243. doi: 10.1002/14651858.CD009243.pub3. Review.

Citations Reporting on Results

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. Review.

Davies JM, Rosen M. Intramuscular diazepam in labour. A double-blind trial in multiparae. Br J Anaesth. 1977 Jun;49(6):601-4.

Friedman EA, Niswander KR, Sachtleben MR. Effect of diazepam on labor. Obstet Gynecol. 1969 Jul;34(1):82-6.

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