Obstetric LaborPhase 4NCT06472232
Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia
A Phase 4 study testing Chloroprocaine in people with Obstetric Labor, run by Women's Hospital School Of Medicine Zhejiang University.
Trial summary
Women requiring epidural labor analgesia were randomized into two groups, one with the local anesthetic chloroprocaine and the other with ropivacaine. The primary outcome was to observe the analgesic scores of the two groups of drugs as well as adverse reactions. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Obstetric Labor
- What is being tested?
- Chloroprocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- No sites listed yet
- Study dates
- 18 Jun 2024to 30 Sep 2025
- Phase
- Phase 4
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primigravid women with full-term pregnancies scheduled for labor analgesia
- Determination of labor onset to cervical dilatation ≤ 5cm;
- Visual analogue scale (VAS) pain score during contractions >50 mm (0 mm = no pain at all, 100 mm = most intense pain);
- Age ≥20 years;
- American Society of Anesthesiologists (ASA) classification II
- Body mass index (BMI) between 18.5 and 30 kg/m2
- Height >155 cm
- Signed informed consent.
Who cannot join
- Twin or multiple pregnancies
- Hypertension
- Severe cardiopulmonary and hepatic or renal disease
- Severe pregnancy comorbidities such as preeclampsia, eclampsia, HELLP syndrome, placenta praevia, placental abruption, etc.
- Cephalopelvic disproportion
- History of allergy to local anesthesia
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- Spinal deformity
- Contraindications to intrathecal anesthesia
- Refusal to participate in the stud
About this study
Official title: Efficacy and Safety of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia Study: a Randomized, Double-blind, Controlled, Multicenter, Noninferiority Clinical Trial
Women requiring epidural labor analgesia were randomized into two groups, one with the local anesthetic chloroprocaine and the other with ropivacaine. The primary outcome was to observe the analgesic scores of the two groups of drugs as well as adverse reactions.
Read the detailed description
Mothers who met the study criteria vertebrae were included and then divided into two groups. Labor analgesia was provided by epidural anesthesia with a low concentration of local anesthetic (chloroprocaine or ropivacaine) combined with sufentanil. Data related to labor analgesia such as pain scores, motor tissue scores, and body temperature were collected and statistically analyzed to compare the efficacy and adverse effects of the two local anesthetics and to draw conclusions.
- Conditions
- Obstetric Labor
- Being tested
- Chloroprocaine
- Keywords
- labor analgesia, Chloroprocaine, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroprocaineDrug
Also called Ropivacaine
Selection of low concentration of chloroprocaine as local anesthetic for labor analgesia
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine group | Experimental | Selection of local anesthetics for epidural labor analgesia with low concentration of chloroprocaine combined with sufentanil Receives: Drug: Chloroprocaine |
| Ropivacaine group | Placebo comparator | Selection of local anesthetics for epidural labor analgesia with low concentration of ropivacaine combined with sufentanil Receives: Drug: Chloroprocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of effective analgesia
Percentage of effective analgesia within 30 min after the first epidural addition at the beginning of labor analgesia in both groups
Measured: 30 min after the first epidural addition at the beginning of labor analgesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start18 Jun 2024 (estimated)
- Primary completion16 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric LaborStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital, International Peace Maternity and Child Health Hospital, Nanjing Medical University, Anhui Women and Children's Medical Center, Jiaxing Maternity and Child Health Care Hospital, Gansu Maternal and Child Health Center, Urumqi Maternal and Child Health Center, Shengjing Hospital, Zhongnan Hospital, Second Affiliated Hospital of Wenzhou Medical University, Second Hospital of Jilin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472232
- Sponsor's protocol ID
- IRB-20240123-R
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia Study: a Randomized, Double-blind, Controlled, Multicenter, Noninferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06472232
- Acronym / sponsor ID
- IRB-20240123-R
- Conditions
- Obstetric Labor
- Keywords
- labor analgesia, Chloroprocaine, Ropivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital, International Peace Maternity and Child Health Hospital, Nanjing Medical University, Anhui Women and Children's Medical Center, Jiaxing Maternity and Child Health Care Hospital, Gansu Maternal and Child Health Center, Urumqi Maternal and Child Health Center, Shengjing Hospital, Zhongnan Hospital, Second Affiliated Hospital of Wenzhou Medical University, Second Hospital of Jilin University
- Study start
- 18 Jun 2024 (estimated)
- Primary completion
- 16 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jun 2024 (actual)
- 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.
Women requiring epidural labor analgesia were randomized into two groups, one with the local anesthetic chloroprocaine and the other with ropivacaine. The primary outcome was to observe the analgesic scores of the two groups of drugs as well as adverse reactions.
Detailed description
Mothers who met the study criteria vertebrae were included and then divided into two groups. Labor analgesia was provided by epidural anesthesia with a low concentration of local anesthetic (chloroprocaine or ropivacaine) combined with sufentanil. Data related to labor analgesia such as pain scores, motor tissue scores, and body temperature were collected and statistically analyzed to compare the efficacy and adverse effects of the two local anesthetics and to draw conclusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine group | Experimental | Drug: ChloroprocaineSelection of local anesthetics for epidural labor analgesia with low concentration of chloroprocaine combined with sufentanil |
| Ropivacaine group | Placebo comparator | Drug: ChloroprocaineSelection of local anesthetics for epidural labor analgesia with low concentration of ropivacaine combined with sufentanil |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primigravid women with full-term pregnancies scheduled for labor analgesia
- Determination of labor onset to cervical dilatation ≤ 5cm;
- Visual analogue scale (VAS) pain score during contractions >50 mm (0 mm = no pain at all, 100 mm = most intense pain);
- Age ≥20 years;
- American Society of Anesthesiologists (ASA) classification II
Key exclusion criteria (9 listed)
- Twin or multiple pregnancies
- Hypertension
- Severe cardiopulmonary and hepatic or renal disease
- Severe pregnancy comorbidities such as preeclampsia, eclampsia, HELLP syndrome, placenta praevia, placental abruption, etc.
- Cephalopelvic disproportion
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 |
|---|---|---|
| ChloroprocaineAlso: RopivacaineSelection of low concentration of chloroprocaine as local anesthetic for labor analgesia | Drug | Chloroprocaine group, Ropivacaine group |
Primary outcome
Percentage of effective analgesia
Time frame: 30 min after the first epidural addition at the beginning of labor analgesia
Percentage of effective analgesia within 30 min after the first epidural addition at the beginning of labor analgesia in both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroprocaine in people with Obstetric Labor, run by Women's Hospital School Of Medicine Zhejiang University.
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 8 inclusion and 9 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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of effective analgesia (time frame: 30 min after the first epidural addition at the beginning of labor analgesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2024.