UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011664 |
|---|---|
| Receipt number | R000013641 |
| Scientific Title | Association between intrapartum fetal head malrotation and motor block by neuraxial analgesia: A randomized trial |
| Date of disclosure of the study information | 2013/09/07 |
| Last modified on | 2023/01/14 22:35:20 |
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Basic information
Public title
Association between intrapartum fetal head malrotation and motor block by neuraxial analgesia: A randomized trial
Acronym
Fetal malrotation and neuraxial analgesia
Scientific Title
Association between intrapartum fetal head malrotation and motor block by neuraxial analgesia: A randomized trial
Scientific Title:Acronym
Fetal malrotation and neuraxial analgesia
Region
| Japan |
Condition
Condition
Singletons in low-risk term deliveries proceeding in the vertex position
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Testing primarily whether the incidence of fetal head malrotation correlates to the technique of neuraxial analgesia and/or to the degree of relaxation of the lower extremities. Testing obstetric factors as possible contributing factor for fetal head malrotation.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Fetal head positioning; start of analgesia, before pushing and at delivery.
Modified Bromage score; 30 min after analgesia and at delivery.
Key secondary outcomes
Visual analog scale; 30 min after analgesia and at delivery.
Maternal satisfaction; within 24 hrs after delivery.
Cervical dilatation and station of the fetal head; start of analgesia, rupture of membrane, and oxytocin infusion if necessary.
Obstetric and neonatal outcomes.
Perineal injuries.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Date: February 2010 and December 2011
Method: traditional high-dose intermittent epidural injection (group H-EPD)
Medication: 0.25% bupivacaine
Dose: 9-12 mL initially, 6 mL thereafter
Frequency: as per request during labor
Interventions/Control_2
Date: February 2010 and December 2011
Method: low-dose continuous epidural infusion (group L-EPD)
Medication: 0.2% ropivacaine
Dose: 9-12 mL initially
Medication: 0.1% ropivacaine + 2 mcg/mL fentanyl
Dose: 8 mL/h
Frequency: continuous infusion during labor
Interventions/Control_3
Date: February 2010 and December 2011
Method: combined spinal-epidural analgesia (group CSEA)
Medication: 0.5% bupivacaine, fentanyl
Dose: 2.0 mg, 20 mcg, respectively, intrathecal injection
Medication: 0.1% ropivacaine + 2 mcg/mL fentanyl
Dose: 8 mL/h
Frequency: continuous infusion during labor
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
| 19 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Singletons in low-risk term pregnancies with the vertex position
Key exclusion criteria
fetal breech position, maternal short stature less than 150 cm, severe maternal complications (pregnancy-induced hypertension, diabetes mellitus, heart disease, coagulation disorder, etc.), estimated fetal body weight more than 4,000 g, fetal complications (fetal growth restriction, known coiling of the umbilical cord, fetal anomaly, etc.), and refusal of the patient
Target sample size
261
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | OKADA |
Organization
Keiyu Hospital
Division name
Anesthesiology
Zip code
2208521
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama, 2208521, Japan
TEL
045-221-8181
h-okada@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hisako |
| Middle name | |
| Last name | OKADA |
Organization
Keiyu Hospital
Division name
Anesthesiology
Zip code
2208521
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama, 2208521, Japan
TEL
045-221-8181
Homepage URL
teatree@carol.ocn.ne.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Hospital
Address
1-15-1, Kitazato, Minami-ku, Sagamihara-shi Kanagawa 252-0373, Japan
Tel
042-778-8111
h-okada@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
| 2013 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s12630-014-0236-4
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12630-014-0236-4
Number of participants that the trial has enrolled
305
Results
The incidence of intrapartum fetal head malrotation was not affected by neuraxial analgesia or the degree of lower extremity relaxation. For obstetric factors, known fetal head malrotation at the start of analgesia and early artificial rupture of membranes at an early stage of labor in primiparas may be associated with intrapartum malrotation.
Results date posted
| 2023 | Year | 01 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Criteria for inclusion in the study were singleton low-risk Japanese term (> 36 weeks) parturients with fetal vertex position requesting labour analgesia.
Participant flow
The study was approved by the Institutional Review Board at Kitasato University Hospital (May 2010). Before neuraxial analgesia, patients were randomly assigned to one of three treatments by choosing from sealed envelopes. The three groups were: intermittent high-dose epidural injection (H-EPD group: initially 0.25% bupivacaine 9-12 mL and an additional 6 mL as per request), low-dose epidural infusion (L-EPD group: 0.2% ropivacaine 9-12 mL, followed by an infusion of 0.1% ropivacaine with fentanyl 2 mcg/mL at 8 mL/hr), or CSEA (CSEA group: an intrathecal dose of bupivacaine 2.0 mg with fentanyl 20 mcg, followed by 0.1% ropivacaine with fentanyl 2 mcg/mL at 8 mL/hr).
Adverse events
None
Outcome measures
Fetal head rotation was examined using ultrasound before or immediately after analgesia and at delivery. Malrotation was defined as an occipital posterior (OP) or occipital transverse position at delivery. The modified Bromage scale (0 = no motor block; 1 = hip blocked; 2 = hip and knee blocked; 3 = hip, knee, and ankle blocked)3 was recorded at delivery, just before the parturient changed to the lithotomy position for pushing, to indicate the degree of motor blockade in the lower extremities.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013641
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