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| ID | Type | Description | Link |
|---|---|---|---|
| NSR083 |
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| Name | Class |
|---|---|
| HRSA/Maternal and Child Health Bureau | FED |
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Labor analgesia is an essential health caring procedure for women. However, epidural analgesia cannot be performed on all subjects for different contraindications, such as lower platelet counter, back infection at the puncture site, and fear of epidural injection etc. Therefore, intravenous analgesia is an alternative for such conditions. Given the influence of intravenous administration of drugs on fetus, the drug selection is very important. Remifentanil, a super-short efficacious opioid, can last for 3-4 minutes after injection, which is similar in both maternal and fetal environment. Thus the fetus-associated side effects would be less than other drugs. The investigators hypothesized that remifentanil would be a superior intravenous drug used with patient-controlled technique for labor analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Intravenous administration of hydromorphone intermittently |
|
| 2 | Experimental | Remifentanil intravenous patient-controlled analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Visual Analog Scale (VAS) rating of pain | Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cesarean delivery | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) | |
| Rate of instrument-assisted delivery | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XiaoFeng Shen, MD | Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Maternal and Child Health Care Hospital | Nanjing | Jiangsu | 210004 | China |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Remifentanil | Drug | Remifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min. |
|
|
| Indications of cesarean delivery | Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals) |
| Duration of analgesia | Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals) |
| Maternal satisfaction with analgesia | At the end of the vaginal delivery (this time period underwent changing in different individuals) |
| Maternal oral temperature | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) |
| Use of oxytocin after analgesia | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) |
| Maximal oxytocin dose | At the end of vaginal delivery (this time period underwent changing in different individuals) |
| Breastfeeding success at 6 weeks after vaginal delivery | At the sixth week after successful delivery |
| Neonatal one-minute Apgar scale | At the first minute of baby was born |
| Neonatal five-minute Apgar scale | At the fifth minute of baby was born |
| Umbilical-cord gases analysis | At the time baby was born (0 min) |
| Neonatal sepsis evaluation | After the baby was born (15 min after delivery) |
| Neonatal antibiotic treatment | After the baby was born (one day after delivery) |
| Incidence of maternal side effects | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |