PainPhase 2NCT02232035
Diazepam at the Active Phase of Labor
A Phase 2 study testing normal saline/diazepam at the active phase of labor in people with Pain and Prolonged Labour, run by Navy General Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Prolonged Labour
- What is being tested?
- normal saline/diazepam at the active phase of labor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primigravida
- at term
- singleton pregnancy
- cephalic presentation
- spontaneous labour
- intact membranes at the beginning of active phase
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Navy General Hospital
Beijing, Beijing Municipality, 100048
Yunhai Chuai, Dr, +86-18810892004, wangyh85@foxmail.com
Aiming Wang, Dr
About this study
Official title: Intravenous Injection of Diazepam at the Beginning of Active Phase of Labor
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
- Being tested
- normal saline/diazepam at the active phase of labor
- Keywords
- diazepam, active phase
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal saline/diazepam at the active phase of laborDrug
A single dose intravenous injection of normal saline (2ml)/diazepam (10mg, 2ml) at the beginning of active phase of labor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: normal saline/diazepam at the active phase of labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: labor
Secondary outcomes (3)
Rate of cervical dilatation
Measured: at the active phase of labor
Pain relief
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.)
Measured: every 30 minutes during the 3-hour period after administration of the trial drug
Type of delivery
Measured: post partum, immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunhai Chuai, Navy General Hospital, Beijing
- Investigators
- Aiming Wang, Dr, Principal investigator, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232035
- Sponsor's protocol ID
- chuaiyunhai-002
- Status last verified
- Sep 2014
- First submitted
- 30 Aug 2014
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23737030Othman 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.
PubMed 22786524Davies 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.
PubMed 326281Friedman EA, Niswander KR, Sachtleben MR. Effect of diazepam on labor. Obstet Gynecol. 1969 Jul;34(1):82-6. No abstract available.
PubMed 4893003
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Injection of Diazepam at the Beginning of Active Phase of Labor
- ClinicalTrials.gov ID
- NCT02232035
- Acronym / sponsor ID
- chuaiyunhai-002
- Conditions
- Pain, Prolonged Labour
- Keywords
- diazepam, active phase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline, active phase of labor | Placebo comparator | Drug: normal saline/diazepam at the active phase of laborA single dose intravenous injection of normal saline (2ml) at the beginning of active phase of labor in the group. |
| diazepam, active phase of labor | Experimental | Drug: normal saline/diazepam at the active phase of laborA single dose intravenous injection of diazepam (10mg, 2ml) at the beginning of active phase of labor in the group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- primigravida
- at term
- singleton pregnancy
- cephalic presentation
- spontaneous labour
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal saline/diazepam at the active phase of laborA single dose intravenous injection of normal saline (2ml)/diazepam (10mg, 2ml) at the beginning of active phase of labor. | Drug | diazepam, active phase of labor, normal saline, active phase of labor |
Primary outcome
Duration of labor
Time frame: labor
Duration of first stage of labor. Duration of second stage of labour. Duration of third stage of labor. Total duration of labor.
3 secondary outcomes
Rate of cervical dilatation
Time frame: at the active phase of labor
Pain relief
Time frame: every 30 minutes during the 3-hour period after administration of the trial drug
Type of delivery
Time frame: post partum, immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
- Background: PubMed 23737030Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009243. doi: 10.1002/14651858.CD009243.pub3.
- Results publication: PubMed 22786524Othman 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.
- Results publication: PubMed 326281Davies 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.
- Results publication: PubMed 4893003Friedman EA, Niswander KR, Sachtleben MR. Effect of diazepam on labor. Obstet Gynecol. 1969 Jul;34(1):82-6. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiming Wang, Dr principal investigator
Navy General Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing normal saline/diazepam at the active phase of labor in people with Pain and Prolonged Labour, run by Navy General Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunhai Chuai, Dr (+86-18810892004, wangyh85@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of labor (time frame: labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232035, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2014.