Diazepam at the Active Phase of Labor

• Sponsor: Navy General Hospital, Beijing (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02232035
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 33.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Prolonged Labour	Drug: normal saline/diazepam at the active phase of labor	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Intravenous Injection of Diazepam at the Beginning of Active Phase of Labor
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Sep 1, 2015
• Anticipated Study Completion Date: Sep 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Duration of labor [labor]

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

Secondary Outcome Measures

1. Rate of cervical dilatation [at the active phase of labor]

2. Pain relief [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.)

3. Type of delivery [post partum, immediately]

Other Outcome Measures

1. Maternal adverse events [two weeks after childbirth]

2. Neonatal adverse events [two weeks after childbirth]

3. Maternal satisfaction [post partum, immediately]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Navy General Hospital	Beijing	Beijing	China	100048

Sponsors and Collaborators

• Navy General Hospital, Beijing

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Yunhai Chuai, Department of Obstetrics and Gynecology, Navy General Hospital, Beijing, Navy General Hospital, Beijing
• ClinicalTrials.gov Identifier: NCT02232035
• Other Study ID Numbers: chuaiyunhai-002
• First Posted: Sep 4, 2014
• Last Update Posted: Sep 4, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Yunhai Chuai, Department of Obstetrics and Gynecology, Navy General Hospital, Beijing, Navy General Hospital, Beijing: diazepam; active phase
• Additional relevant MeSH terms: Diazepam

Study Results

No Results Posted as of Sep 4, 2014