Epidural Analgesia in the Latent Phase of Labor and the Risk of Cesarean Delivery: A 5-year Randomized Controlled Trial

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The optimal timing of epidural analgesia (EA) for labor has been controversial, particularly as to how early in the latent phase parturients can safely benefit from it. Clinical guidelines before 2006 recommended that initiation of EA be delayed until 4.0 to 5.0 cm cervical dilation. After reviewing the current literature, the authors concluded that no study had addressed initiation of EA when cervical dilation is <2.0 cm. The hypothesis of this 5-year randomized controlled trial was that patient-controlled EA (PCEA) initiated in women in early labor (cervical dilation ≥1.0 cm dilation) does not increase the risk of prolonged labor or rate of cesarean section (CS), compared with women who wait for cervical dilation of ≥4.0 cm.
All healthy nulliparae with singleton pregnancies in spontaneous labor at term in the maternity/child care unit of Nanjing Medical University (China) between January 2003 and December 2007 were screened for eligibility. Women from 18 to 45 years willing to accept EA were randomly assigned to 1 of 2 groups; latent phase analgesia (cervical dilation at least 1.0 cm) or active phase (≥4.0 cm). Women randomized to the active phase group were allowed intramuscular meperidine analgesia until cervical dilation was ≥4.0 cm. EA was initiated in all women with a 15-mL mixture of 0.125% (1.25 mg/mL) ropivacaine with 0.3 μg/mL sufentanil, followed by maintenance of analgesia with PCEA (bolus 10 mL, lockout interval 15 min, maximum hourly limit 30 mL, no background infusion). Visual analog pain scores (VAS) of 0 to 100 were recorded at request for analgesia and hourly from the initiation of EA to the end of labor; and side effects were noted. The primary outcome was the rate of CS; secondary outcomes were characteristics of labor, analgesia, and delivery, and incidence of side effects from EA.
Fifteen thousand women were screened and 12,793 subjects were randomly assigned to the 2 groups; 164 were excluded, primarily because of protocol violations; 6274 women in the latent phase analgesia group and 6355 in the active phase group completed the study. The groups had similar demographic and obstetric characteristics. Median cervical dilation at time of initiation of EA was 1.6 cm in the latent phase group and 5.1 cm in the active phase group. There were no significant differences between the groups in rate of CS (approximately 23%; P=0.51), indications for CS, percentages treated with oxytocin infusion, maximum oxytocin dose, or rate of instrument-assisted delivery (approximately 12%; P=0.10). There were no differences in the duration of labor, duration of latent and active phases, time from request for analgesia to complete dilation, or time to delivery. Average VAS measurements were all similar. Duration of EA was longer in the latent phase group (median, 12.6 h, vs. 4.8 h; P=0.02). The incidence of intrapartum nausea and vomiting was lower in the latent phase group, but fewer women experienced pruritus in the active phase group. Overall maternal satisfaction scores with analgesia were higher in the latent phase group (median, 84) than the active phase group (62). Breastfeeding success at 6 weeks after delivery was lower in the latent phase group (70.1%, vs. 77.8%; P<0.0001), but there were no differences in neonatal outcomes.
These findings corroborate those of other studies published in the past 5 years; all concluded that neuraxial labor analgesia (epidural or combined-spinal epidural) initiated in the latent phase of labor does not increase rates of CS in nulliparous women or prolong the duration of labor, compared with delaying neuraxial analgesia until dilation of ≥4 cm.

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