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

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ClinicalTrials.gov Identifier: NCT03167905
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Depression, Postpartum Analgesia, Obstetrical Anesthesia, Obstetrical Device: Epidural delivery system Drug: Entonox Drug: Meperidine Drug: Ultiva Drug: Fentanyl Drug: Ropivacaine Phase 2 Phase 3

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.

During any time of the labour period, the patient is allowed to switch the pain relief option upon request.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cross over or switch to the other group of analgesia is allowed.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Role of Epidural Analgesia Versus Non-epidural Analgesia in Postnatal Depression and Persistent Pain Development: a Randomized Controlled Trial
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : January 16, 2020
Estimated Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Epidural group
Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.
Device: Epidural delivery system
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Drug: Fentanyl
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Drug: Ropivacaine
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Active Comparator: Non-epidural group
Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.
Drug: Entonox
Entonox will be given upon request in non-epidural group.
Other Name: Laughing gas

Drug: Meperidine
Intramuscular pethidine (75mg/1.5ml) will be given upon request in non-epidural group.
Other Name: Pethidine

Drug: Ultiva
Intravenous patient controlled remifentanil (20-40mcg/ml) is only given when the patient rejects or cannot receive pethidine and entonox in non-epidural group..
Other Name: Remifentanil




Primary Outcome Measures :
  1. The incidence of postnatal depression in both groups [ Time Frame: 6-10 weeks after delivery ]
    Edinburgh Postnatal Depression Scale (EPDS) score>13


Secondary Outcome Measures :
  1. The incidence of acquiring post-delivery persistent pain in both groups [ Time Frame: 6-10 weeks after delivery ]
    Pain score>3 in the perineal, surgical scar or abdomen region that lasts for at least 6 weeks post-delivery

  2. Pain vulnerability in both groups (1) [ Time Frame: Upon recruitment until 6-10 weeks after delivery ]
    Assessment via Pain Catastrophizing Scale (PCS) questionnaire before and after delivery

  3. Pain vulnerability in both groups (2) [ Time Frame: Upon recruitment until 6-10 weeks after delivery ]
    Assessment via Central Sensitisation Inventory (CSI) questionnaire before and after delivery

  4. Psychological vulnerability in both groups (1) [ Time Frame: Upon recruitment until 5 days after delivery ]
    Assessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery

  5. Psychological vulnerability in both groups (2) [ Time Frame: Upon recruitment until 5 days after delivery ]
    Assessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery

  6. Psychological vulnerability in both groups (3) [ Time Frame: Upon recruitment until 5 days after delivery ]
    Assessment via Perceived Stress Scale (PSS) questionnaire before delivery

  7. Pain severity in both groups [ Time Frame: During labour till one day after delivery ]
    Pain score>3 during labour



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167905


Contacts
Contact: Ban Leong Sng, FANZCA +6563941081 sng.ban.leong@kkh.com.sg
Contact: Alex Tiong Heng Sia, MMED+ +6563941081 Alex.Sia.TH@kkh.com.sg

Locations
Singapore
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: Ban Leong Sng, FANZCA    +6563941081    sng.ban.leong@kkh.com.sg   
Contact: Alex Tiong Heng Sia, MMED+    +6563941081    alex.sia.th@kkh.com.sg   
Principal Investigator: Ban Leong Sng, FANZCA         
Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
Principal Investigator: Ban Leong Sng, FANZCA KK Women's and Children's Hospital

Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT03167905     History of Changes
Other Study ID Numbers: 2017/2090
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KK Women's and Children's Hospital:
Anesthesia, Obstetrical
Epidural anesthesia
Postnatal depression
Persistent pain

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Fentanyl
Remifentanil
Meperidine
Nitrous Oxide
Ropivacaine
Entonox
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local
Hypnotics and Sedatives
Anesthetics, Combined
Anesthetics, Inhalation
Analgesics, Non-Narcotic