Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
400 participants
INTERVENTIONAL
2014-09-30
2015-09-30
Brief Summary
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Hypothesis: Diazepam reduced the duration of labor and the severity of pain in labor.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* at term
* singleton pregnancy
* cephalic presentation
* spontaneous labour
* intact membranes at the beginning of active phase
Exclusion Criteria
* 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
18 Years
35 Years
FEMALE
Yes
Sponsors
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Navy General Hospital, Beijing
OTHER
Responsible Party
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Yunhai Chuai
Department of Obstetrics and Gynecology, Navy General Hospital, Beijing
Principal Investigators
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Aiming Wang, Dr
Role: PRINCIPAL_INVESTIGATOR
Navy General Hospital, Beijing
Locations
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Navy General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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;2012(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.
Other Identifiers
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chuaiyunhai-002
Identifier Type: -
Identifier Source: org_study_id
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