UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062099 |
|---|---|
| Receipt number | R000070857 |
| Scientific Title | The Association between Preoperative Fasting in Mothers Undergoing Elective Caesarean Section and Neonatal Hypoglycaemia The PETITY Study Randomised Controlled Trial |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/30 13:59:12 |
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Basic information
Public title
The Association between Preoperative Fasting in Mothers Undergoing Elective Caesarean Section and Neonatal Hypoglycaemia
Acronym
RCT PETIT-Y Study
Scientific Title
The Association between Preoperative Fasting in Mothers Undergoing Elective Caesarean Section and Neonatal Hypoglycaemia
The PETITY Study Randomised Controlled Trial
Scientific Title:Acronym
RCT PETITY Study
Region
| Japan |
Condition
Condition
History of cesarean section, neonatal hypoglycemia
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to clarify the impact of differences in maternal preoperative fasting management on the incidence of neonatal hypoglycemia and to compare and evaluate preoperative management strategies that promote physical and psychological comfort for both the mother and the newborn.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of cases in which at least one of the three blood glucose measurements taken after birth (immediately after birth, 1 hour later, and 2 hours later) was less than 50 mg/dL
Key secondary outcomes
Whether the newborn was hospitalized (therapeutic intervention)
Mother's hunger and thirst scores (questionnaire to be developed), time to recovery of postoperative bowel motility, first passage of gas, postoperative nausea and vomiting, and length of postoperative hospital stay. Maternal insulin and blood glucose levels upon entering the operating room, and umbilical cord blood insulin and blood glucose levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Upon admission, patients are randomly assigned to either the diet and fluid intake group or the oral rehydration solution group.
Interventions/Control_2
Measure insulin and blood glucose levels in the mother and umbilical cord blood upon entering the operating room
Interventions/Control_3
Measure the newborn's blood glucose level three times (immediately after birth, 1 hour later, and 2 hours later).
Interventions/Control_4
Compilation of data on my mothers postoperative hunger and thirst scores, time to recovery of bowel motility, first passage of gas, postoperative nausea and vomiting, and length of postoperative hospital stay
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 1 | days-old | > |
Gender
Male and Female
Key inclusion criteria
Pregnant women at our hospital undergoing elective cesarean sections without complications (breech presentation, history of previous cesarean sections, concurrent uterine fibroids, use of anticoagulants) and their newborns (full-term)
Key exclusion criteria
(1) Emergency cesarean section
(2) Gestational diabetes mellitus (GDM)
(3) Hypertensive disorders of pregnancy (HDP)
(4) Preterm infants
(5) Low birth weight infants
(6) Thyroid disorders (select only cases with well-controlled disease and a history of outpatient care)
(7) Other cases deemed inappropriate by the principal investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | EITA |
| Middle name | |
| Last name | TAMANAHA |
Organization
Social Medical Corporation Yuuai-kai, Yuuai Medical Center
Division name
pediatrics
Zip code
901-0224
Address
50-212 Yone, Tomigusuku City, Okinawa Prefecture
TEL
0988503811
etamanaha1188@gmail.com
Public contact
Name of contact person
| 1st name | EITA |
| Middle name | |
| Last name | TAMANAHA |
Organization
Social Medical Corporation Yuuai-kai
Division name
Medical Department/Pediatrics
Zip code
901-0224
Address
50-212 Yone, Tomigusuku City, Okinawa Prefecture
TEL
0988503811
Homepage URL
etamanaha1188@gmail.com
Sponsor or person
Institute
Social Medical Corporation Yuuai-kai, Yuuai Medical Center
Institute
Department
Personal name
EITA TAMANAHA
Funding Source
Organization
Social Medical Corporation Yuuai-kai, Yuuai Medical Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
No
Name of secondary funder(s)
No
IRB Contact (For public release)
Organization
Social Medical Corporation Yuuai-kai, Ethics Review Committee
Address
50-212 Yone, Tomigusuku City, Okinawa Prefecture
Tel
0988503811
etamanaha@yuuai.or.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
社会医療法人友愛会（沖縄県）、友愛医療センター（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 30 | Day |
Last modified on
| 2026 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070857
