Unique ID issued by UMIN | UMIN000011664 |
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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 |
Association between intrapartum fetal head malrotation and motor block by neuraxial analgesia: A randomized trial
Fetal malrotation and neuraxial analgesia
Association between intrapartum fetal head malrotation and motor block by neuraxial analgesia: A randomized trial
Fetal malrotation and neuraxial analgesia
Japan |
Singletons in low-risk term deliveries proceeding in the vertex position
Obstetrics and Gynecology | Anesthesiology | Adult |
Others
NO
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.
Bio-equivalence
Confirmatory
Explanatory
Not applicable
Fetal head positioning; start of analgesia, before pushing and at delivery.
Modified Bromage score; 30 min after analgesia and at delivery.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
NO
Numbered container method
3
Treatment
Medicine | Maneuver |
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
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
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
19 | years-old | <= |
45 | years-old | >= |
Female
Singletons in low-risk term pregnancies with the vertex position
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
261
1st name | Hisako |
Middle name | |
Last name | OKADA |
Keiyu Hospital
Anesthesiology
2208521
3-7-3 Minatomirai, Nishi-ku, Yokohama, 2208521, Japan
045-221-8181
h-okada@juntendo.ac.jp
1st name | Hisako |
Middle name | |
Last name | OKADA |
Keiyu Hospital
Anesthesiology
2208521
3-7-3 Minatomirai, Nishi-ku, Yokohama, 2208521, Japan
045-221-8181
teatree@carol.ocn.ne.jp
Kitasato University Hospital
None
Self funding
Kitasato University Hospital
1-15-1, Kitazato, Minami-ku, Sagamihara-shi Kanagawa 252-0373, Japan
042-778-8111
h-okada@juntendo.ac.jp
NO
2013 | Year | 09 | Month | 07 | Day |
https://link.springer.com/article/10.1007/s12630-014-0236-4
Published
https://link.springer.com/article/10.1007/s12630-014-0236-4
305
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.
2023 | Year | 01 | Month | 14 | Day |
Criteria for inclusion in the study were singleton low-risk Japanese term (> 36 weeks) parturients with fetal vertex position requesting labour analgesia.
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).
None
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.
Completed
2010 | Year | 01 | Month | 31 | Day |
2010 | Year | 01 | Month | 31 | Day |
2010 | Year | 02 | Month | 01 | Day |
2011 | Year | 12 | Month | 31 | Day |
2011 | Year | 12 | Month | 31 | Day |
2012 | Year | 12 | Month | 31 | Day |
2012 | Year | 12 | Month | 31 | Day |
2013 | Year | 09 | Month | 06 | Day |
2023 | Year | 01 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013641
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