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Labor PainNCT03381495

The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

A study testing Ropivacaine Hydrochloride, Sufentanil in people with Labor Pain and Pregnancy Outcomes, run by Deng Dongrui at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 15 to 50 years, women only
What is being tested?
Ropivacaine Hydrochloride, Sufentanil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
16 May 2018to 31 Dec 2019
Phase
Interventional
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 15 to 50 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • healthy and full term pregnant women

Who cannot join

  • the pregnant women with complications

Trial locations and contacts

1 site in 1 country.

Xun Gong contact

+8613886174675

gongxun4019@163.com

China1 site, 1 recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Xun Gong, M.D., +8613886174675, gongxun4019@163.com

    Dongji Han, M.D., +8618971583899, handongjihospital@163.com

    Recruiting

Other trials in China

About this study

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.

Being tested
Ropivacaine Hydrochloride, Sufentanil
Keywords
Epidural Labor Analgesia, length of labor stage, fetal outcomes, maternal outcomes, postpartum depression, exercise
Medical subject headings
Labor Pain, Mental Disorders, Depression, Postpartum, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine Hydrochloride, SufentanilDrug

    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.

Study groups in NCT03381495
Study groupRoleWhat they receive
Epidural analgesia during laborExperimentalThe 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.
Receives: Drug: Ropivacaine Hydrochloride, Sufentanil
Non-epidural analgesia during laborNo interventionWomen who refused epidural labor analgesia were included in the non-epidural analgesia group, and they don't receive epidural analgesia during labor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Labor duration

    Duration of three stages of labor.

    Measured: At the end of the delivery

Secondary outcomes (6)

  1. 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.

    Measured: 1 minute after the infant is born

  2. 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.

    Measured: 5 minutes after the infant is born

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. Postpartum depression

    Assess the risk of postpartum depression among all participants using EPDS，HAMA.

    Measured: 3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.

  6. The mode of delivery

    Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery.

    Measured: At the end of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2017
  2. Study start16 May 2018
  3. Primary completion1 Sep 2018 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03381495
Sponsor's protocol ID
TJ-C20171201
Status last verified
Jul 2018
First submitted
2 Dec 2017
Last updated
13 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zha Y, Gong X, Yang C, Deng D, Feng L, Luo A, Wan L, Qiao F, Zeng W, Chen S, Wu Y, Han D, Liu H. Epidural analgesia during labor and its optimal initiation time-points: A real-world study on 400 Chinese nulliparas. Medicine (Baltimore). 2021 Mar 5;100(9):e24923. doi: 10.1097/MD.0000000000024923.

    PubMed 33655955

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine Hydrochloride, Sufentanil in people with Labor Pain and Pregnancy Outcomes, run by Deng Dongrui 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 1 inclusion and 1 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 13 Jul 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Xun Gong (+8613886174675, gongxun4019@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Labor duration (time frame: At the end of the delivery). 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 NCT03381495, which also lists 1 linked publication.

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 13 Jul 2018.

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