OBJECTIVE:Oxytocin is the first-line uterotonic agent for labor induction and augmentation, but high-dose or prolonged use is often associated with adverse effects. Phloroglucinol, an antispasmodic, may alleviate cervical spasm and promote dilation. While existing randomized controlled trials (RCTs) suggest that combining phloroglucinol with oxytocin may shorten labor duration safely, a comprehensive meta-analysis is lacking. This study aimed to evaluate the efficacy and safety of intravenous phloroglucinol combined with oxytocin in term parturients to provide evidence-based guidance for clinical practice.
METHODS:This systematic review was registered in PROSPERO (CRD420251143546). A systematic search was conducted of PubMed, Embase, Scopus, CNKI, Wanfang, and VIP databases from inception to July 2025. A total of 20 RCTs involving 2,819 parturients were included. Primary outcomes included total labor duration, first-stage labor duration, neonatal Apgar score, rate of normal vaginal delivery (NVD), Bishop score, degree of cervical dilation, and maternal-neonatal safety outcomes (fetal distress, postpartum hemorrhage, neonatal asphyxia, uterine atony, cervical laceration, and cervical edema). Meta-analysis was performed using Stata 18.0. A fixed-effects model was applied when I2 < 50 %, and a random-effects model was used when I2 ≥ 50 %. Subgroup and sensitivity analyses were conducted for outcomes with high heterogeneity. Publication bias was assessed for outcomes reported in more than seven studies.
RESULTS:Compared to oxytocin alone, combination therapy significantly reduced total labor duration (MD = -3.05, 95 % CI [-3.91, -2.18], P < 0.001) and first-stage labor duration (MD = -3.08, 95 % CI [-3.96, -2.20], P < 0.001).The combination therapy did not significantly affectApgar scores (SMD = -0.08, 95 % CI [-0.02, 0.18], P = 0.12) but increased the rate of normal vaginal delivery (NVD) (OR = 1.10, 95 % CI [1.02, 1.18], P = 0.01). Safety analysis showed that combination therapywas associated withreduced risks of fetal distress (OR = 0.42, 95 % CI [0.25, 0.90], P = 0.02), postpartum hemorrhage (OR = 0.27, 95 % CI [0.12, 0.59], P < 0.01), neonatal asphyxia (OR = 0.47, 95 % CI [0.25, 0.90], P = 0.02), uterine atony (OR = 0.46, 95 % CI [0.22, 0.94], P = 0.03), cervical laceration (OR = 0.17, 95 % CI [0.03, 0.92], P = 0.04), and cervical edema (OR = 0.25, 95 % CI [0.06, 0.98], P = 0.05). Most outcomes exhibited low heterogeneity (I2 < 50 %), and sensitivity analysisconfirmed the robustness of the findings.
CONCLUSION:Intravenous administration of phloroglucinol combined with oxytocin in term parturients significantly accelerates labor progression and increases the rate of vaginal delivery without increasing adverse maternal or neonatal events. This strategy appears to beasafe and effectiveapproachfor labor management. Further validation through large-scale, multicenter RCTs is recommended.