Clinical trial NCT02232035: Diazepam at the Active Phase of Labor
Official title: Intravenous Injection of Diazepam at the Beginning of Active Phase of Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain
Prolonged Labour
Keywords: diazepam
active phase
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Duration of labor
timeFrame: labor
Secondary outcomes:
measure: Rate of cervical dilatation
timeFrame: at the active phase of labor
measure: Pain relief
timeFrame: every 30 minutes during the 3-hour period after administration of the trial drug
measure: Type of delivery
timeFrame: post partum, immediately
Other outcomes:
measure: Maternal adverse events
timeFrame: two weeks after childbirth
measure: Neonatal adverse events
timeFrame: two weeks after childbirth
measure: Maternal satisfaction
timeFrame: post partum, immediately
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Aiming Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Othman M, Jones L, Neilson JP. Non-opioid drugs for pain management in labour. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD009223. doi: 10.1002/14651858.CD009223.pub2.
citation: 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.
citation: Friedman EA, Niswander KR, Sachtleben MR. Effect of diazepam on labor. Obstet Gynecol. 1969 Jul;34(1):82-6. No abstract available.