Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

N/ACompletedNCT02920489

Peking University First Hospital200 enrolled

Overview

Neuraxial analgesia is the gold standard to relieve labor pain. A recent "Practice guidelines for obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation \< 5 cm) or on a individualized basis. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.

Neuraxial analgesia is the gold standard to relieve labor pain. It also helps to attenuate maternal anxiety and improve maternal satisfaction. A recent "Practice guidelines for obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation \< 5 cm) or, for some special patients, be provided on a individualized basis. Studies showed that, when compared with late administration, early administration of labor analgesia resulted in equivocal findings for spontaneous, instrumented, and cesarean delivery. The investigators hypothesize that neuraxial labor analgesia provided on an individualized basis will further improve analgesia quality and maternal satisfaction. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Labor Pain Analgesia, Obstetrical Early Medical Intervention

Interventions

Individualized epidural analgesiaDRUG

Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the numeric rating scale is 5 or higher. Analgesia will be terminated at the end of the third stage of labor.

Routine epidural analgesiaDRUG

Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the cervix is dilated to 1 cm or more. Analgesia will be terminated at the end of the third stage of labor.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 36 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Nulliparas (aged 18-36 years) with single cephalic term pregnancy; 2. Plan to deliver vaginally, and are considered suitable for a trial of vaginal delivery by obstetricians; 3. Admitted to the delivery room; 4. Agree to receive epidural analgesia during labor. Exclusion Criteria: 1. History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists); 2. Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy. 3. Other reasons that are considered unsuitable for study participation.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

The most severe labor pain score during labor

Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.

Time frame: Assessed at 24 hours after delivery

Secondary Outcomes

Incidence of instrumental delivery

Time frame: At the time of delivery

Incidence of Cesarean delivery

Time frame: At the time of delivery

Neonatal Apgar score

Time frame: At 1 and 5 minutes after delivery

Maternal satisfaction with labor analgesia

Assessed with the Likert scale, where 1=extremely dissatisfaction, 2=dissatisfaction, 3=neither dissatisfaction nor satisfaction, 4=satisfaction, 5=extremely satisfaction.

Time frame: Assessed at 24 hours after delivery

Persistent pain score at 24 hours and 42 days after delivery

Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.

Time frame: At 24 hours and 42 days after delivery

Rate of breast-feeding

Time frame: At 24 hours and 42 days after delivery

Incidence of postpartum depression

Postpartum depression will be diagnosed as Edinburgh postnatal depression scale of 10 or higher.

Data from ClinicalTrials.gov

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