European Journal of Cardiovascular Medicine

Induction of labour is a common obstetric intervention used in approximately 20% of pregnancies. [1] A prerequisite for a successful induction is a favourable cervix, commonly assessed using the Bishop Score. [2] When the cervix is unfavourable (Bishop score ≤4), cervical ripening methods are employed to increase the chances of successful induction. [3] Cervical ripening can be achieved using pharmacological or mechanical methods. Dinoprostone (PGE2) is a widely used pharmacological agent that induces cervical softening and dilatation through enzymatic collagen breakdown. [4] It is administered either as a gel, insert, or tablet. [5] While effective, prostaglandins may have side effects such as uterine hyperstimulation and fetal distress. [6] Mechanical methods, particularly the use of a transcervical Foley catheter, are also well-established. The Foley catheter works by direct pressure on the internal os and stimulating endogenous prostaglandins. [7] It has the advantage of being cheaper, widely available, and associated with a lower risk of uterine hyperstimulation. [8] However, it may cause discomfort, infection, and a longer induction time. [9]

Multiple studies have compared these two methods. Sciscione et al. reported that Foley catheters were as effective as dinoprostone in achieving vaginal delivery but had a longer induction time. [10] A randomized controlled trial by Pennell et al. showed higher patient satisfaction with prostaglandins but fewer maternal side effects with mechanical methods. [11] Despite numerous studies, there remains debate over which method is superior in terms of safety, efficiency, and maternal satisfaction. [12]

This study aims to compare the efficacy and safety of intracervical dinoprostone gel versus Foley catheter insertion for labour induction in women with an unfavorable cervix.

This prospective, comparative study was conducted over 18 months at a tertiary care hospital’s Obstetrics and Gynaecology Department.

Sample Size

A total of 200 term pregnant women were enrolled and randomly assigned into two equal groups: Group A (Dinoprostone gel) and Group B (Foley catheter).

Inclusion Criteria

• Singleton pregnancy
• Gestational age ≥37 weeks
• Cephalic presentation
• Bishop score ≤4
• Intact membranes
• Reactive non-stress test

Exclusion Criteria

• Previous cesarean section or uterine surgery
• Placenta previa or abruption
• Multiple gestation
• Fetal growth restriction or anomalies
• Active labor
• Contraindications to prostaglandins

Methodology

After obtaining informed consent, participants were assigned to either Group A or B using a computer-generated randomization table.

• Group A (n=100): Received 0.5 mg intracervical dinoprostone gel every 6 hours for a maximum of 3 doses.
• Group B (n=100): Foley catheter (16F) was inserted and balloon inflated with 30 ml saline. It was removed after 12 hours or earlier if expelled.

After cervical ripening, labor was augmented with oxytocin if necessary. Maternal and fetal monitoring was done per standard protocol.

Outcome Measures

Primary outcomes:

• Induction-to-delivery interval
• Mode of delivery (vaginal/cesarean)

Secondary outcomes:

• Maternal complications (hyperstimulation, infection)
• Neonatal outcomes (Apgar score, NICU admission)

Statistical Analysis

Data were analyzed using SPSS software. Continuous variables were expressed as mean ± SD and analyzed using Student’s t-test. Categorical variables were compared using Chi-square test. A p-value <0.05 was considered statistically significant.

Table 1: Demographic Profile

In table 1, Both groups are demographically similar (mean age ~26 years; *p* = 0.42). Comparable pregnancy history (mean gravida ~1.6–1.7; *p* = 0.56). Nearly identical gestational ages (mean ~39 weeks; *p* = 0.65).

Table 2: Induction-to-Delivery Interval

In table 2, Dinoprostone achieved delivery 3.6 hours faster on average (10.2 hours) compared to the Foley catheter (13.8 hours). The narrower standard deviation (SD) for dinoprostone (±3.6 vs. ±4.2) suggests more consistent/predictable delivery times with prostaglandin use.

Table 3: Mode of Delivery

Table 4: Maternal Complications

Table 5: Neonatal Outcomes

Table 6: Need for Oxytocin Augmentation

This study aimed to compare the effectiveness of dinoprostone gel versus mechanical dilatation using Foley catheter in labor induction among women with an unfavorable cervix. Our findings showed that dinoprostone gel was associated with a significantly shorter induction-to-delivery interval and higher vaginal delivery rates compared to the Foley catheter.

The results are consistent with Sciscione et al., who also reported shorter labor with prostaglandins. [13] Similarly, a meta-analysis by Jozwiak et al. concluded that pharmacological methods were more effective in shortening labor duration. [14] However, mechanical methods had the advantage of lower hyperstimulation rates.

Maternal complications differed significantly. Dinoprostone was associated with higher rates of uterine hyperstimulation, which aligns with observations by Sanchez-Ramos et al. [15] On the other hand, Foley catheter use was linked to a higher rate of infection, likely due to its invasive nature and prolonged placement.

In terms of neonatal outcomes, both groups showed comparable Apgar scores and NICU admissions, which is consistent with the study by Pennell et al. [16] this suggests that both methods are equally safe for the fetus when appropriately monitored.

An important consideration is the resource setting. In low-resource areas, Foley catheters may be more practical due to their low cost and minimal systemic side effects. [17-24] However, when efficacy and shorter labor are priorities, dinoprostone gel may be preferred despite its cost and side effect profile.

In inference, both methods are effective for cervical ripening, but the choice should be individualized based on patient profile, institutional protocols, and resource availability. Dinoprostone gel is more effective than mechanical dilatation for achieving timely vaginal delivery in women with unfavorable cervices but increases uterine hyperstimulation risk. Mechanical dilatation is a viable alternative, particularly for women with prostaglandin contraindications, though vigilance for infection is warranted. Individualized selection based on maternal risk profile is recommended.

Dinoprostone gel is more effective than Foley catheter in terms of reducing induction-to-delivery interval and increasing vaginal delivery rates. However, it carries a higher risk of hyperstimulation. Mechanical dilatation is safer, cost-effective, and associated with fewer systemic side effects but may prolong labor. Clinicians should individualize induction strategies based on maternal and institutional contexts.

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