An interventional study of Ropivacaine Hydrochloride, Sufentanil in Labor Pain, Pregnancy Outcomes and Psychological Disorder, sponsored by Deng Dongrui. Status unknown at 1 site in China. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-07-13.
Sponsored by Deng Dongrui · Not applicable, Interventional, and Treatment
Labor analgesia can alleviate intrapartum pain, in the importance of the delivery is very obvious.But some researches think labor analgesia may affect the progress of labor, increase the cesarean section rate.This research adopts the epidural anesthesia to study labor analgesia effects on delivery outcomes and long-term emotional and psychological effects on the mothers. Besides, we also want to study the effect of exercise during pregnancy on the mode of delivery.
423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 347 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Deng Dongrui is the lead sponsor of 3 studies on the registry; none are open to participants now.
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healthy and full term pregnant women
Exclusion Criteria:
the pregnant women with complications
The epidural analgesia technique was used to maintain analgesia for parturients who request labor analgesia.First, we injected a test dose of 5ml 1% lidocaine . If not adverse effects were observed 10 minutes after the test dose, the parturient then received a bolus injection of an initial dose of 8-10 ml mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate. We then connected the epidural catheter with a patient-controlled epidural analgesia (PCA) pump, which provided patients the same mixed solution at 8-10ml/h until the delivery of neonates.
Drug: Ropivacaine Hydrochloride, Sufentanil
Women who refused epidural labor analgesia were included in the non-epidural analgesia group, and they don't receive epidural analgesia during labor
Drug pages: Ropivacaine · Sufentanil
In this research one group will receive epidural analgesia(Ropivacaine Hydrochloride, Sufentanil), data will be collected and analyzed between this group and non-epidural analgesia group.
Labor duration
Duration of three stages of labor.
Time frame: At the end of the delivery
1 minute Apgar index
The index indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10.
Time frame: 1 minute after the infant is born
5 minute Apgar index
The index indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10.
Time frame: 5 minutes after the infant is born
Visual Analogue Scores(VAS)
VAS is the most common pain scale for quantification. The score is from 0 to 10. The score is higher, the patient will be more painful. That will indicate if the analgesia is effective.
Time frame: 5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.
Modified Bromage scores
The modified Bromage score is the most frequently used measure of motor block. The scores is from 0 to 3. In this scale, the intensity of motor block is assessed by the patient's ability to move their lower extremities (0: no motor paralysis; 1: inability to raise extended leg, but able to move knee and foot; 2: inability to raise extended leg and to move knee, but able to move foot; 3: inability to raise extended leg or to move knee and foot). That will indicate if the analgesia block the patient motor too much.
Time frame: 5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.
Postpartum depression
Assess the risk of postpartum depression among all participants using EPDS，HAMA.
Time frame: 3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.
The mode of delivery
Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery.
Time frame: At the end of delivery
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ropivacaine · Sufentanil
Deng Dongrui