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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cervical dilatation | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal adverse events | two weeks after childbirth | |
| Neonatal adverse events | two weeks after childbirth | |
| Maternal satisfaction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunhai Chuai, Dr | Contact | +86-18810892004 | wangyh85@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Aiming Wang, Dr | Navy General Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy General Hospital | Beijing | Beijing Municipality | 100048 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23737030 | Background | 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. | |
| 22786524 | Result | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| every 30 minutes during the 3-hour period after administration of the trial drug |
| Type of delivery | post partum, immediately |
| post partum, immediately |
| 326281 | 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. |
| 4893003 | Result | Friedman EA, Niswander KR, Sachtleben MR. Effect of diazepam on labor. Obstet Gynecol. 1969 Jul;34(1):82-6. No abstract available. |