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NCT Number: NCT02920489

Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

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.

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Key information

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparas (aged 18-36 years) with single cephalic term pregnancy;
  • Plan to deliver vaginally, and are considered suitable for a trial of vaginal delivery by obstetricians;
  • Admitted to the delivery room;
  • Agree to receive epidural analgesia during labor.

Exclusion criteria

  • History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists);
  • 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.
  • Other reasons that are considered unsuitable for study participation.

Treatment and study plan

Individualized epidural analgesia

Drug

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.

Other names: Individualized analgesia with sufentanil and ropivacaine

Routine epidural analgesia

Drug

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.

Other names: Routine analgesia with sufentanil and ropivacaine

Primary outcomes

  1. The most severe labor pain score during labor

    Time frame: Assessed at 24 hours after delivery

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

Secondary outcomes

  1. Incidence of instrumental delivery

    Time frame: At the time of delivery

    Incidence of instrumental delivery

  2. Incidence of Cesarean delivery

    Time frame: At the time of delivery

    Incidence of Cesarean delivery

  3. Neonatal Apgar score

    Time frame: At 1 and 5 minutes after delivery

    Neonatal Apgar score

  4. Maternal satisfaction with labor analgesia

    Time frame: Assessed at 24 hours after delivery

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

  5. Persistent pain score at 24 hours and 42 days after delivery

    Time frame: At 24 hours and 42 days after delivery

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

  6. Rate of breast-feeding

    Time frame: At 24 hours and 42 days after delivery

    Rate of breast-feeding

  7. Incidence of postpartum depression

    Time frame: At 42 days after delivery

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

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Impact of Individualized Timing of Analgesia on the Effectiveness of Labor Analgesia: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2016
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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