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CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery) (CODEPAD)

Primary Purpose

Depression, Postpartum, Analgesia, Obstetrical, Anesthesia, Obstetrical

Status
Active
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Epidural delivery system
Entonox
Meperidine
Ultiva
Fentanyl
Ropivacaine
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Postpartum focused on measuring Anesthesia, Obstetrical, Epidural anesthesia, Postnatal depression, Persistent pain

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients at term (36 weeks gestation or more) (nulliparous and multiparous);
  • With a singleton fetus.

Exclusion Criteria:

  • Multiple pregnancies;
  • Non-cephalic fetal presentation;
  • Obstetric complications (e.g. pre-eclampsia, uncontrolled hypertension, uncontrolled diabetes);
  • Elective and urgent caesarean section (not from delivery suite).

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Epidural group

Non-epidural group

Arm Description

Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.

Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.

Outcomes

Primary Outcome Measures

The incidence of major postnatal depression in both groups
Edinburgh Postnatal Depression Scale (EPDS) score>=13
The incidence of (clinically significant, probable) postnatal depression in both groups
Edinburgh Postnatal Depression Scale (EPDS) score>=10

Secondary Outcome Measures

The incidence of acquiring post-delivery persistent pain in both groups
Pain score>3 in the perineal, surgical scar or abdomen region that lasts for at least 6 weeks post-delivery
Pain vulnerability in both groups (1)
Assessment via Pain Catastrophizing Scale (PCS) questionnaire before and after delivery
Pain vulnerability in both groups (2)
Assessment via Central Sensitisation Inventory (CSI) questionnaire before and after delivery
Pain vulnerability in both groups (3)
Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain
Psychological vulnerability in both groups (1)
Assessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery
Psychological vulnerability in both groups (2)
Assessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery
Psychological vulnerability in both groups (3)
Assessment via Perceived Stress Scale (PSS) questionnaire before delivery
Pain severity in both groups
Pain score>3 during labour
Preferences for labor analgesia
Recruited patients will be administered a survey on Discrete Choice Experiment (DCE) and other questions on their preferences for labor analgesia. For DCE, nine tasks will be included in which parturients will choose one of four hypothetical forms of labor analgesia: 1) epidural analgesia, 2) pethidine, 3) Entonox (nitrous oxide-oxygen mixture), and 4) no labor analgesia, which varies with regards to six attributes: 1) pain intensity following treatment, 2) duration of second stage of labor, 3) risk of instrumental delivery, 4) risk of back pain, 5) risk of permanent nerve injury, and 6) out-of-pocket cost.
Preferences for epidural analgesia
Recruited patients will be administered a survey on their preferences and opinions on epidural analgesia, including their concerns on possible risk of epidural analgesia e.g. instrumental delivery, prolonged duration of second stage of labor, back pain etc.
Chinese version of Angle Labor Pain Questionnaire (A-LPQ)
Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain. The tool comprises 22 items divided into five subscales on the childbirth pain experience: the enormity of the pain, the fear and anxiety, uterine contraction pain, birthing pain, and the back pain/ long haul. Each item is scaled from 0 to 10, implying a range from non to worst possible or extremely (where applicable), and therefore has a total score ranged from 0 to 220. The higher the score, the greater the labor pain.

Full Information

First Posted
May 2, 2017
Last Updated
October 2, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03167905
Brief Title
CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)
Acronym
CODEPAD
Official Title
Comparison of the Role of Epidural Analgesia Versus Non-epidural Analgesia in Postnatal Depression and Persistent Pain Development: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Postnatal depression affects about 10-15% of women after childbirth. Approximately 3-5% of women experience a moderate-to-severe depression that requires medical attention. This study aims to investigate the implication of pain relief choice in reducing the postnatal depression of women who deliver their babies.
Detailed Description
If the patients have not decided on which pain relief method to be used, and would like to take part in this study, they will be assigned to either epidural or non-epidural pain relief for labour based on the study randomization result. Blood samples will be drawn to study the presence of known functional polymorphisms in candidate genes associated with depression, pain, stress and anxiety. Patients will be followed up with study questionnaires related to pain and postnatal depression screening during the study. For some of the patients, a discrete choice experiment (DCE) on pain relief choice will be conducted, and their preferences on epidural analgesia will be asked. During any time of the labour period, the patient is allowed to switch the pain relief option upon request.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum, Analgesia, Obstetrical, Anesthesia, Obstetrical
Keywords
Anesthesia, Obstetrical, Epidural anesthesia, Postnatal depression, Persistent pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Cross over or switch to the other group of analgesia is allowed.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
881 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural group
Arm Type
Experimental
Arm Description
Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.
Arm Title
Non-epidural group
Arm Type
Active Comparator
Arm Description
Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.
Intervention Type
Device
Intervention Name(s)
Epidural delivery system
Intervention Description
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Intervention Type
Drug
Intervention Name(s)
Entonox
Other Intervention Name(s)
Laughing gas
Intervention Description
Entonox will be given upon request in non-epidural group.
Intervention Type
Drug
Intervention Name(s)
Meperidine
Other Intervention Name(s)
Pethidine
Intervention Description
Intramuscular pethidine (75mg/1.5ml) will be given upon request in non-epidural group.
Intervention Type
Drug
Intervention Name(s)
Ultiva
Other Intervention Name(s)
Remifentanil
Intervention Description
Intravenous patient controlled remifentanil (20-40mcg/ml) is only given when the patient rejects or cannot receive pethidine and entonox in non-epidural group..
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Primary Outcome Measure Information:
Title
The incidence of major postnatal depression in both groups
Description
Edinburgh Postnatal Depression Scale (EPDS) score>=13
Time Frame
6-10 weeks after delivery
Title
The incidence of (clinically significant, probable) postnatal depression in both groups
Description
Edinburgh Postnatal Depression Scale (EPDS) score>=10
Time Frame
6-10 weeks after delivery
Secondary Outcome Measure Information:
Title
The incidence of acquiring post-delivery persistent pain in both groups
Description
Pain score>3 in the perineal, surgical scar or abdomen region that lasts for at least 6 weeks post-delivery
Time Frame
6-10 weeks after delivery
Title
Pain vulnerability in both groups (1)
Description
Assessment via Pain Catastrophizing Scale (PCS) questionnaire before and after delivery
Time Frame
Upon recruitment until 6-10 weeks after delivery
Title
Pain vulnerability in both groups (2)
Description
Assessment via Central Sensitisation Inventory (CSI) questionnaire before and after delivery
Time Frame
Upon recruitment until 6-10 weeks after delivery
Title
Pain vulnerability in both groups (3)
Description
Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain
Time Frame
Upon recruitment till end of first stage of labor (1 day)
Title
Psychological vulnerability in both groups (1)
Description
Assessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery
Time Frame
Upon recruitment until 5 days after delivery
Title
Psychological vulnerability in both groups (2)
Description
Assessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery
Time Frame
Upon recruitment until 5 days after delivery
Title
Psychological vulnerability in both groups (3)
Description
Assessment via Perceived Stress Scale (PSS) questionnaire before delivery
Time Frame
Upon recruitment until 5 days after delivery
Title
Pain severity in both groups
Description
Pain score>3 during labour
Time Frame
During labour till one day after delivery
Title
Preferences for labor analgesia
Description
Recruited patients will be administered a survey on Discrete Choice Experiment (DCE) and other questions on their preferences for labor analgesia. For DCE, nine tasks will be included in which parturients will choose one of four hypothetical forms of labor analgesia: 1) epidural analgesia, 2) pethidine, 3) Entonox (nitrous oxide-oxygen mixture), and 4) no labor analgesia, which varies with regards to six attributes: 1) pain intensity following treatment, 2) duration of second stage of labor, 3) risk of instrumental delivery, 4) risk of back pain, 5) risk of permanent nerve injury, and 6) out-of-pocket cost.
Time Frame
Prior to labor and delivery
Title
Preferences for epidural analgesia
Description
Recruited patients will be administered a survey on their preferences and opinions on epidural analgesia, including their concerns on possible risk of epidural analgesia e.g. instrumental delivery, prolonged duration of second stage of labor, back pain etc.
Time Frame
Prior to labor and delivery
Title
Chinese version of Angle Labor Pain Questionnaire (A-LPQ)
Description
Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain. The tool comprises 22 items divided into five subscales on the childbirth pain experience: the enormity of the pain, the fear and anxiety, uterine contraction pain, birthing pain, and the back pain/ long haul. Each item is scaled from 0 to 10, implying a range from non to worst possible or extremely (where applicable), and therefore has a total score ranged from 0 to 220. The higher the score, the greater the labor pain.
Time Frame
Upon recruitment till end of first stage of labor (1 day)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients at term (36 weeks gestation or more) (nulliparous and multiparous); With a singleton fetus. Exclusion Criteria: Multiple pregnancies; Non-cephalic fetal presentation; Obstetric complications (e.g. pre-eclampsia, uncontrolled hypertension, uncontrolled diabetes); Elective and urgent caesarean section (not from delivery suite).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ban Leong Sng, FANZCA
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)

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