UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039343 |
|---|---|
| Receipt number | R000044874 |
| Scientific Title | Prospective cohort study on postpartum pain and recovery after vaginal delivery with and without labor analgesia. |
| Date of disclosure of the study information | 2020/01/31 |
| Last modified on | 2024/02/03 12:50:34 |
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Basic information
Public title
Prospective cohort study on postpartum pain and recovery after vaginal delivery with and without labor analgesia.
Acronym
Prospective study on postpartum pain and recovery.
Scientific Title
Prospective cohort study on postpartum pain and recovery after vaginal delivery with and without labor analgesia.
Scientific Title:Acronym
Prospective study on postpartum pain and recovery.
Region
| Japan |
Condition
Condition
Post vaginal delivery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effects of labor analgesia on postpartum pain and recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postpartum pain score on numeric rating scale.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
Women who are:
- planning to have vaginal delivery at St Luke's International Hospital before 11/24/2020.
- able to read, write and have conversation in Japanese
- equal to or above 20 years old
- primipara
- 35 weeks gestation or later
- without serious maternal or fetal complications
Key exclusion criteria
- maternal complications: chronic or pregnancy-induced hypertension requiring medical interventions, active psychiatric disorders (including depression, anxiety disorder), diabetes requiring medical intervention, non-singleton pregnancy, chronic pain or chronic opioid use.
- allergy to materials used in the activity tracker (fitbit)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Rimu |
| Middle name | |
| Last name | Suzuki |
Organization
St Luke's International Hospital
Division name
Department of Anesthesia
Zip code
104-8560
Address
9-1, Akashi-cho, Chuo-ku
TEL
03-3541-5151
rimus@luke.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Maeda |
Organization
Brigham and Women's Hospital
Division name
Department of Anesthesiology, Perioperative and Pain Medicine
Zip code
02445
Address
75 Fruit St. Boston MA 02115
TEL
1-617-732-5500
Homepage URL
amaeda@bwh.harvard.edu
Sponsor or person
Institute
St Luke's International Univerity
Institute
Department
Personal name
Funding Source
Organization
Society for Women's Health Science Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Management Office, St Luke's International Hospital
Address
104-8560 9-1 Akashi-cho, Chuo-ku, Tokyo
Tel
03-3541-5151
kenkyukikaku@luke.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0292393
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0292393
Number of participants that the trial has enrolled
300
Results
95 and 116 had a vaginal delivery without and with epidural analgesia. The median number of steps increased daily in both groups, with no significant difference between the groups. Postpartum pain was mild overall, with median pain scores <4 and similar between the groups. MFI and EQ-5D-5L scores were worst on postpartum (PP) day 1 and gradually improved to antenatal level by 1-month PP visit. The use of epidural analgesia was associated with lower odds of achieving adequate PP ambulation.
Results date posted
| 2024 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 10 | Month | 05 | Day |
Baseline Characteristics
Primiparous women anticipating a vaginal childbirth between January 2020 and May 2021 were enrolled. Women with major comorbidities or postpartum complications and those who underwent a cesarean delivery were excluded.
Participant flow
Daily step count was measured using a wrist-worn activity tracker (FitbitTM Inspire HR) for 120 hours after vaginal childbirth. Subjective
fatigue levels and health-related quality of life were assessed using the Multidimensional Fatigue Inventory (MFI) and EuroQol 5 Dimension 5 Level (EQ-5D-5L), respectively, at the 3rd trimester antenatal visit, on postpartum day 1 and 3, and at the one-month postpartum visit. Rest and dynamic pain scores and the
Adverse events
Not applicable.
Outcome measures
Daily step count was measured using a wrist-worn activity tracker (FitbitTM Inspire HR) for 120 hours after vaginal childbirth. Subjective
fatigue levels and health-related quality of life were assessed using the Multidimensional Fatigue Inventory (MFI) and EuroQol 5 Dimension 5 Level (EQ-5D-5L), respectively, at the 3rd trimester antenatal visit, on postpartum day 1 and 3, and at the one-month postpartum visit. Rest and dynamic pain scores and the
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 04 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 04 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 05 | Day |
Other
Other related information
We will obtain data on postpartum pain and physical recovery, using questionnaires and an ambulation tracker.
Management information
Registered date
| 2020 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044874
