Clinical trial

Comparison of the Role of Epidural Analgesia Versus Non-epidural Analgesia in Postnatal Depression and Persistent Pain Development: a Randomized Controlled Trial

Name

2017/2090

Description

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.

Trial arms

Trial start

2017-06-15

Estimated PCD

2021-07-19

Trial end

2025-12-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

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.

Arms:

Epidural group

Entonox

Entonox will be given upon request in non-epidural group.

Arms:

Non-epidural group

Other names:

Laughing gas

Meperidine

Intramuscular pethidine (75mg/1.5ml) will be given upon request in non-epidural group.

Arms:

Non-epidural group

Other names:

Pethidine

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..

Arms:

Non-epidural group

Other names:

Remifentanil

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.

Arms:

Epidural group

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.

Arms:

Epidural group

Size

881

Primary endpoint

The incidence of major postnatal depression in both groups

6-10 weeks after delivery

The incidence of (clinically significant, probable) postnatal depression in both groups

6-10 weeks after delivery

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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cross over or switch to the other group of analgesia is allowed.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 881, 'type': 'ACTUAL'}}

Updated at

2024-01-05

1 organization

4 products

1 drug

5 indications

Organization

KK Women's and Children's Hospital

Product

Entonox

Indication

Major Depressive Disorder