Diazepam at the Active Phase of Labor

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02232035
• Other study ID #: chuaiyunhai-002
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 30, 2014
• Last updated: September 3, 2014
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2014
• Source: Navy General Hospital, Beijing
• Contact: Yunhai Chuai, Dr
• Phone: +86-18810892004
• Email: wangyh85[@]foxmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science FoundationChina: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain
• Prolonged Labour

Intervention

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.

Locations

Country	Name	City	State
China	Navy General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (4)

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

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal adverse events		two weeks after childbirth	Yes
Other	Neonatal adverse events		two weeks after childbirth	Yes
Other	Maternal satisfaction		post partum, immediately	Yes
Primary	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	Yes
Secondary	Rate of cervical dilatation		at the active phase of labor	Yes
Secondary	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	Yes
Secondary	Type of delivery		post partum, immediately	Yes

External Links

•   Non-opioid drugs for pain management in labour