Diazepam at the Active Phase of Labor

NCT ID: NCT02232035

Last Updated: 2014-09-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Prolonged Labour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Group Type PLACEBO_COMPARATOR

normal saline/diazepam at the active phase of labor

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

normal saline/diazepam at the active phase of labor

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Navy General Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Yunhai Chuai

Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Central Contacts

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Yunhai Chuai, Dr

Role: CONTACT

+86-18810892004

Facility Contacts

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Yunhai Chuai, Dr

Role: primary

+86-18810892004

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.

Reference Type BACKGROUND
PMID: 23737030 (View on PubMed)

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.

Reference Type RESULT
PMID: 22786524 (View on PubMed)

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.

Reference Type RESULT
PMID: 326281 (View on PubMed)

Friedman EA, Niswander KR, Sachtleben MR. Effect of diazepam on labor. Obstet Gynecol. 1969 Jul;34(1):82-6. No abstract available.

Reference Type RESULT
PMID: 4893003 (View on PubMed)

Other Identifiers

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chuaiyunhai-002

Identifier Type: -

Identifier Source: org_study_id

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