Diazepam at the Active Phase of Labor

NCT02232035 | Unknown Phase 2 DMC

• 1 other identifier: chuaiyunhai-002
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Prolonged Labour

Keywords

diazepam; active phase

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Rate of cervical dilatation

  at the active phase of labor

• Pain relief

  every 30 minutes during the 3-hour period after administration of the trial drug

• Type of delivery

  post partum, immediately

Other Outcomes (3)

• Maternal adverse events

  two weeks after childbirth

• Neonatal adverse events

  two weeks after childbirth

• Maternal satisfaction

  post partum, immediately

Study Arms (2)

normal saline, active phase of labor

PLACEBO COMPARATOR

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

diazepam, active phase of labor

EXPERIMENTAL

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

Interventions

normal saline/diazepam at the active phase of labor 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; normal saline, active phase of labor

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• primigravida
• at term
• singleton pregnancy
• cephalic presentation
• spontaneous labour
• intact membranes at the beginning of active phase

You may not qualify if:

• 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

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

Location

Related Publications (4)

• 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.

  PMID: 23737030 BACKGROUND

• 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.

  PMID: 22786524 RESULT

• 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.

  PMID: 326281 RESULT

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

  PMID: 4893003 RESULT

MeSH Terms

Conditions

Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Aiming Wang, Dr

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunhai Chuai, Dr

CONTACT

+86-18810892004; wangyh85@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Study Record Dates

• First Submitted: August 30, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

CN (1)