UMIN-ICDS Clinical Trial

Public title

Labor analgesia and distress during procedures after vaginal birth

Acronym

Distress during procedures after vaginal birth

Scientific Title

Effect of Labor Analgesia on Distress During Procedures After Vaginal Delivery: A Single-Center Prospective Cohort Study

Scientific Title:Acronym

Labor analgesia and postpartum procedural distress cohort study

Region

Japan

Condition

Physical and psychological distress associated with procedures after vaginal delivery

Classification by specialty

Obstetrics and Gynecology	Anesthesiology	Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the Postpartum Procedure Global Distress Score (PPGDS) between women with effective neuraxial labor analgesia at the time of postpartum procedures and women receiving standard care without neuraxial labor analgesia, among women undergoing procedures including perineal, vaginal, or cervical suturing after vaginal delivery. Associations with pain, discomfort, fear, anxiety, loss of control, embarrassment and dignity, procedural ease, additional analgesia, procedure interruptions, blood loss, and complications will also be explored.

Basic objectives2

Others

Basic objectives -Others

To evaluate the association between effective neuraxial analgesia during postpartum procedures and patient-reported global distress in routine clinical care.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Postpartum Procedure Global Distress Score (PPGDS; 0-10), assessed by the participant 30 minutes to 2 hours after completion of the target postpartum procedures. The score reflects global distress across the procedures, including pain, discomfort, fear, anxiety, embarrassment, and helplessness. A score of 0 indicates no distress and 10 the worst imaginable distress. This is a study-defined, single-item patient-reported outcome and is not an established validated scale.

Key secondary outcomes

At 30 minutes to 2 hours after procedure completion: proportions with PPGDS scores of 7 or higher and 4 or higher; procedural pain, non-pain discomfort/pressure/pulling sensations, fear, anxiety, loss of control/helplessness, and embarrassment/compromised dignity (each NRS 0-10); acceptability of the procedural experience and desire for earlier or stronger anesthesia/analgesia (each on a 5-point scale); preference for the same analgesic method in a similar situation (yes/no/unsure).
On postpartum day 1: perineal pain NRS 0-10.
During procedures: use and number of additional local anesthetic administrations, pudendal nerve blocks, epidural top-ups, intravenous analgesics, or other analgesia; number of interruptions; total procedure and suturing durations; blood loss, postpartum hemorrhage, transfusion, and additional uterotonic use.
After procedure completion: operator-rated procedural ease NRS 0-10.
From medical records through 1 month postpartum: vaginal wall or perineal hematoma, repeat suturing, infection, urinary retention, epidural-related complications, repeat visits, and prolonged hospitalization.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

50

years-old

>

Gender

Female

Key inclusion criteria

Pregnant women aged 18 years or older at consent who meet the following criteria: gestational age of 35 weeks 0 days to 37 weeks 6 days and planned delivery at Kitasato University Hospital; no regular labor contractions, or awaiting planned induction without severe pain and able to understand the study explanation; singleton pregnancy with vaginal delivery planned or considered acceptable; ability to understand the study and complete questionnaires in Japanese; and provision of written informed consent. The primary analysis includes those who deliver vaginally at 37 weeks 0 days or later, undergo target procedures including perineal, vaginal, or cervical suturing, and provide PPGDS data.

Key exclusion criteria

Withdrawal of consent after enrollment; cesarean delivery; delivery before 37 weeks 0 days; no target postpartum procedure such as perineal, vaginal, or cervical suturing after vaginal delivery (these participants are counted in the consented cohort and participant flow); immediate postpartum patient-reported outcome assessment judged ethically or medically inappropriate by the principal investigator or attending physician because of stillbirth or deterioration in maternal or neonatal condition; inability to complete the questionnaire within the assessment window because of postpartum hemorrhage, impaired consciousness, emergency surgery, or similar circumstances; or anesthesia/procedures not comparable with routine delivery-room procedures, such as general anesthesia, spinal anesthesia, or complex repair in an operating room.

Target sample size

100

Name of lead principal investigator

1st name	Shunsuke
Middle name
Last name	Hyuga

Organization

Kitasato University

Division name

Department of Anesthesiology, School of Medicine

Zip code

252-0375

Address

1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture

TEL

0427788606

Email

shyuga@kitasato-u.ac.jp

Name of contact person

1st name	Shunsuke
Middle name
Last name	Hyuga

Organization

Kitasato university

Division name

Department of Anesthesiology, School of Medicine

Zip code

2520375

Address

1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan

TEL

0427788606

Homepage URL

Email

shyuga@kitasato-u.ac.jp

Institute

Kitasato University

Institute

Department

Personal name

Organization

Kitasato University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Kitasato University School of Medicine and Hospital Ethics Committee

Address

1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan

Tel

042-778-8273

Email

rinri@med.kitasato-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

03

Day

Date of IRB

2026

Year

07

Month

27

Day

Anticipated trial start date

2026

Year

09

Month

13

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Single-center prospective observational cohort study at Kitasato University Hospital. Pregnant women providing consent and delivering between institutional permission and December 31, 2027 are eligible. Written consent is obtained at 35 weeks 0 days to 37 weeks 6 days during an outpatient visit or planned admission before regular labor, or before planned induction when there is no severe pain or urgency and the study can be understood. Initial consent during labor is generally not obtained. Anesthesia, analgesia, and procedures are not assigned for research. Women whose neuraxial labor analgesia is continued or topped up and documented by clinicians as available for postpartum procedures at their start are compared with women receiving standard care without neuraxial labor analgesia. Neuraxial analgesia that is clearly ineffective or discontinued at the time of procedures is handled separately in sensitivity analyses. Necessary local anesthesia, additional analgesia, and procedure interruptions are provided in both groups; analgesia is not restricted or delayed for research. Data are collected from medical records and participant and operator questionnaires. The target is 100 consented participants, with approximately 70 in the primary analysis. PPGDS is analyzed using linear regression to estimate the adjusted mean difference and 95% confidence interval. Missing primary outcomes are excluded from the primary analysis, with reasons described. Follow-up extends from consent to 1 month postpartum; information at 1 month is limited to routine records, without additional visits. The study period ends on March 31, 2028. Institutional protocol number: B26-053.

Registered date

2026

Year

09

Month

08

Day

Last modified on

2026

Year

09

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071947