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Association between intrapartum fetal head malrotation and motor block by neuraxial analgesia: A randomized trial

Association between intrapartum fetal head malrotation and motor block by neuraxial analgesia: A randomized trial - Fetal malrotation and neuraxial analgesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011664
Enrollment
261
Registered
2013-09-07
Start date
2010-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Singletons in low-risk term deliveries proceeding in the vertex position

Interventions

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:

Sponsors

Kitasato University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Singletons in low-risk term pregnancies with the vertex position

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Fetal head positioning; start of analgesia, before pushing and at delivery. Modified Bromage score; 30 min after analgesia and at delivery.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactHisako OKADA

Keiyu Hospital Anesthesiology

teatree@carol.ocn.ne.jp045-221-8181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026