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Completed

NCT Number: NCT00380978

Neuraxial Versus Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery

The purpose of this study in nulliparous women undergoing induction of labor is to determine whether initiation of neuraxial analgesia compared to systemic opioid analgesia early in labor (< 4 cm cervical dilation)affects the cesarean delivery rate.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

Women in early labor frequently request pain medication. Obstetricians may prescribe narcotics (administered as an intravenous (IV) or intramuscular (IM) injection). However, IV or IM narcotics provide incomplete pain relief and have maternal and fetal/neonatal side effects, e.g., maternal drowsiness, respiratory depression, nausea, vomiting, and neonatal respiratory depression. Other obstetricians allow their patients to request early neuraxial (spinal or epidural) analgesia. The results of several studies comparing patients who received epidural versus IV/IM narcotic labor analgesia (not specifically in early labor)suggest that initiation of early neuraxial analgesia may be associated with higher Cesarean delivery rates. It has been hypothesized that epidural/spinal local anesthetics may induce pelvic musculature relaxation leading to failure of fetal descent and rotation. However, early pain may be a marker for other factors that increase the risk of Cesarean delivery, e.g., large or malpositioned baby, or dysfunctional labor. Whether or not early neuraxial analgesia (particularly if narcotic based, which would not cause pelvic muscle paralysis) compared to IV/IM narcotics, adversely affects the outcome of labor has not been studied in a randomized, prospective fashion. The purpose of this study is to compare Cesarean and forcep delivery rates, and quality of pain relief, in first-time mothers undergoing induction of labor who receive neuraxial versus IV/IM analgesia for early labor (cervical dilation < 4 cm).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • induction of labor
  • nulliparity
  • >36 weeks gestation
  • singleton
  • vertex position
  • cervical dilation < 4 cm at first request for analgesia
  • desires neuraxial analgesia

Exclusion criteria

  • spontaneously laboring
  • multiparity
  • nonvertex presentation
  • at or >4cm at analgesia request
  • chronic opioid therapy
  • acute opioid therapy within 4 hours of analgesia request
  • allergy to study drugs (hydromorphone, fentanyl, bupivacaine, lidocaine)

Treatment and study plan

combined spinal epidural analgesia

Procedure

Analgesia was initiated in the early group using a standard needle-through-needle technique with intrathecal fentanyl 25 mcg and an epidural test dose of lidocaine 15 mg/ml and epinephrine 5 mcg/ml in 3ml. At the second analgesia request, the cervix was examined. Epidural analgesia was initiated with a dilute bupivicaine/fentanyl solution if the cervix was less than 4 cm. If the cervix was 4 cm or more, epidural analgesia was initiated with bupivicaine 1.25 mg/ml. If no cervical exam was performed at the second request for analgesia, the cervix was assumed to be at least 4 cm dilated. Thereafter, analgesia was maintained in all participants in the early group with patient-controlled epidural analgesia.

Other names: CSE

late analgesia (systemic)

Procedure

Analgesia was initiated in the late group with hydromorphone 1mg intramuscularly (IM) and 1 mg intravenously (IV). If the cervix was less than 4 cm at the second analgesia request, hydromorphone analgesia was repeated. Epidural analgesia was initiated with bupivicaine 1.25 mg/ml if the cervix was 4 cm or more. At the third analgesia request, epidural analgesia was initiated regardless of cervical dilation. Thereafter, epidural analgesia was maintained with patient controlled analgesia until delivery.

Other names: Dilaudid, narcotic

Primary outcomes

  1. Delivered by Cesarean Section

    Time frame: Time form initiation of labor analgesia to delivery (up to 24 hours)

    The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.

Secondary outcomes

  1. Instrumented Vaginal Delivery

    Time frame: At time of decision for delivery

    The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.

  2. Duration of Labor

    Time frame: Initiation of induction of labor to time of delivery

    Labor was induced by initiating an oxytocin infusion or by infusing extra-amniotic saline followed by oxytocin. All participants had continuous external electronic fetal heart rate (FHR) monitoring and tocodynamometry. Internal fetal scalp electrodes were placed when the external tracing was not interpretable, and intrauterine pressure catheters were used to measure the intensity of contractions when deemed necessary by the obstetricians. Artificial rupture of membranes was performed, and nurses titrated oxytocin infusions according to institutional protocol.

  3. Indication for Cesarean Delivery

    Time frame: At time of decision for delivery

    The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.

  4. Analgesia Efficacy

    Time frame: At first and second analgesia requests

    Patients were asked to rate their average pain score using an 11-point verbal rating score (VRS)for pain (0 - 10: 0= no pain, 10= worst pain imaginable) between 1st and 2nd analgesia request.

  5. Nausea

    Time frame: At second analgesia request

    Participants were asked to rate their nausea (as none, mild, moderate, or severe) and report the presence or absence of vomiting.

  6. Neonatal Outcome (APGAR Score < 7 at 5 Minutes)

    Time frame: APGAR score at 5 minutes

    Infant's Apgar scores measured at 5 minutes of life and were assigned by nurses and pediatricians responsible for neonatal assessment. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing the five values. The categories are skin color, pulse, reflex to stimulation, muscle tome, and breathing. The test was done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 3 and below are generally regarded as critically low, 4 to 6 fairly low, and 7 to 10 generally normal.

  7. Vomiting

    Time frame: Vomiting at second analgesia request

    Vomiting during labor analgesia

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • International Anesthesia Research Society (IARS)

Registry information

Official study title

Early Compared With Late Neuraxial Analgesia in Nulliparous Labor Induction

Important dates

Study start
2001
Primary completion
2008
Study completion
2008
First posted
Sep 27, 2006
Registry last updated
Apr 14, 2014

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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