UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the improvement of anesthetic method for cervical cerclage
Title of the study (Brief title)	Study of the improvement of anesthetic method for cervical carclage
Region	Japan

Condition
Condition	Cervical Insufficiency
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of adding morphine and fentanyl to local anesthetic in spinal anesthesia for cervical cerclage.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The analgesic effect of intraoperative and postoperative period Need for additional analgesic
Key secondary outcomes	The side effects for the patient and fetus

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	The patient undergoing cervical cerclage
Key exclusion criteria	Contraindications to spinal anesthesia Contraindications to morphine or fentanyl
Target sample size	10

Research contact person
Name of lead principal investigator	Atsuko Hirano
Organization	Tokyo Metropolitan Bokutoh Hospital
Division name	Dept.Anesthesiology
Address	4-23-15,Kotobashi,Sumida-ku,Tokyo,Japan
TEL	03-3633-6151
Email	hirano.k.a.1980@gmail.com

Public contact
Name of contact person	Atsuko Hirano
Organization	Tokyo Metropolitan Bokutoh Hospital
Division name	Dept.Anesthesiology
Address	4-23-15,Kotobashi,Sumida-ku,Tokyo,Japan
TEL	03-3633-6151
Homepage URL
Email	hirano.k.a.1980@gmail.com

Sponsor
Institute	Tokyo Metropolitan Bokutoh Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Bokutoh Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 02 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 06 Day
Anticipated trial start date	2015 Year 02 Month 15 Day
Last follow-up date	2018 Year 06 Month 10 Day
Date of closure to data entry	2018 Year 06 Month 10 Day
Date trial data considered complete	2018 Year 06 Month 10 Day
Date analysis concluded	2018 Year 06 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Compared to the same number of consecutive cases before the study, administration of morphine and fentanyl to the spinal subarachnoid space significantly increased the analgesic effect during and after the operation. Although there was no serious side effect, the incidence of itching sensation was higher in the opioid administration group.
Other related information	Evaluate the improvement of intraoperative and postoperative analgesia and the side effects to the mother and fetus of adding morphine and fentanyl to local anesthetic during spinal anesthesia for cervical cerclage.

Management information
Registered date	2015 Year 02 Month 14 Day
Last modified on	2018 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019168