UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035153 |
|---|---|
| Receipt number | R000039979 |
| Scientific Title | Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: dural puncture epidural versus combined spinal-epidural anesthesia (prospective non-randomized comparative study) |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2021/12/10 17:06:26 |
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Basic information
Public title
Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: dural puncture epidural versus combined spinal-epidural anesthesia (prospective non-randomized comparative study)
Acronym
Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: DPE vs CSEA (non-randomized comparative study)
Scientific Title
Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: dural puncture epidural versus combined spinal-epidural anesthesia (prospective non-randomized comparative study)
Scientific Title:Acronym
Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia: DPE vs CSEA (non-randomized comparative study)
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence of fetal severe prolonged deceleration after induction of labor analgesia with CSEA and DPE.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of fetal severe prolonged deceleration within 90 minutes after induction of labor analgesia
Key secondary outcomes
mode of delivery, evaluation of satisfaction after delivery, Apgar score, umbilical cord blood analysis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In the DPE(intervention)group, the dura is punctured but no medication is administered into subarachnoid space at the timing of induction of labor analgesia. Then 5ml of 0.125% levobupivacaine(2.5 mcg/ml of fentanyl)is administered via epidural catheter, followed by 10ml in 5 minutes.
In the CSEA(control)group, 0.5% hyperbaric bupivacaine and 10mcg of fentanyl are administerd.
The composition of the PCEA is the same for both groups: 200 ml of 0.08% levobupivacaine(2 mcg/ml of fentanyl), 0 ml/hr, PCA: 5 ml/dose, LOT: 15 min.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
age is 20 years old or older
primipara
Cervix dilation is 5cm or more at the timing of induction of labor
paper based informed consent is obtained before labor starts
Key exclusion criteria
multipara
abnormal cardio tocogram at the timing of induction of labor
contraindication of epidural anesthesia
whom research director judged not qualified as research subject
Target sample size
870
Research contact person
Name of lead principal investigator
| 1st name | SHOKO |
| Middle name | |
| Last name | OKAHARA |
Organization
Juntendo University Hospital
Division name
Anesthesiology
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Shoko0719@yahoo.com
Public contact
Name of contact person
| 1st name | SHOKO |
| Middle name | |
| Last name | OKAHARA |
Organization
Juntendo University Hospital
Division name
Anesthegiology
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Homepage URL
Shoko0719@yahoo.com
Sponsor or person
Institute
Juntendo University Hospital
department of anesthegiology
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
3-1-3 Hongo Bunkyo-ku Tokyo Japan
Tel
03-3813-3111
sokahara@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000039979
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000039979
Number of participants that the trial has enrolled
302
Results
Demographic characteristics were similar in DPE and CSEA groups.
The primary outcome: the incidence of PD (including bradycardia) within 90 minutes after induction of labor analgesia, was significantly lower with DPE.
Results date posted
| 2021 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1:nulliparous
2:age between 20 to 50
3:eligible for vaginal delivery
4:no contraindication for neuraxial anesthesia
5:full-term pregnancy (37 to 41 weeks)
6:cervix dilation at induction smaller than 6cm were eligible for the study
7:normal CTG tracing within 30 minutes before induction of labor analgesia
8:no spontaneous normal delivery within 90 minutes after induction of labor analgesia
Participant flow
Parturients who delivered at Juntendo University Hospital between Marth 2019 and April 2020 with the baseline characteristics were candidates for DPE group as intervention.
Parturients who delivered in the same institution prior to the study with equivalent inclusion criteria as DPE group were enrolled for CSEA group. The data was collected from April 1, 2018, until the number of cases was equal to that of DPE group.
COVID-19 pandemic occurred during the study period made it difficult to continue recruiting patients. By April 2020 when the first state of emergency was declared by the Japanese government, 151 eligible cases for prospective DPE group had been collected. After consulting with a statistician, we altered sample size to 151 for each group and obtained with an approval of the ethics committee.
Adverse events
There was no maternal death or fetal death.
Outcome measures
The primary outcome: the incidence of PD (including bradycardia) within 90 minutes after induction of labor analgesia.
The secondary outcomes were divided into anesthetic, maternal and fetal outcomes.
Anesthetic outcomes: CTG classification before and after induction of anesthesia, NRS at induction, PCEA consumption during labor, physician top-up for breakthrough pain.
Maternal outcomes: cervix dilation/cervical effacement/fetal station at induction, rate of forceps delivery, rate of caesarean section, blood loss, duration of labor and use of uterotonics.
Fetal outcomes: Apgar score, umbilical cord artery blood pH/BE.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 06 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039979
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| Registered date | File name |
| Research case data | |
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