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

KK Women's and Children's Hospital

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Analgesia, Obstetrical; Depression, Postpartum; Anesthesia, Obstetrical

Treatments: Drug: Entonox; Drug: Ultiva; Drug: Ropivacaine; Device: Epidural delivery system; Drug: Meperidine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03167905

2017/2090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 881 patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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881 participants in 2 patient groups

Epidural group

Experimental group

Description:

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

Treatment:

Drug: Fentanyl

Device: Epidural delivery system

Drug: Ropivacaine

Non-epidural group

Active Comparator group

Description:

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

Treatment:

Drug: Meperidine

Drug: Ultiva

Drug: Entonox