Induction of labour (IOL) is a widely used obstetric intervention aimed at artificially initiating labour, with its global prevalence nearly doubling since 1990¹. However, IOL rates vary significantly across different regions due to inconsistencies in clinical guidelines and lack of consensus². In high-income countries, approximately 25% of neonates are born following IOL, whereas the rates remain comparatively lower in low- and middle-income countries (LMIC).The onset of labour is influenced by cervical ripening and dilation, accompanied by labour pains^3,4. Cervical ripening involves softening of the cervix, which precedes labour contractions and facilitates foetal passage. This process results from complex biochemical changes that cause collagen realignment and rearrangement. As a result, the cervix thins, softens, relaxes, and dilates in response to uterine contractions. Key changes include decreased collagen fibre alignment, reduced fibre strength, and weakened extracellular matrix tensile strength. Additionally, an increase in cervical decorin (dermatan sulphate proteoglycan 2) leads to collagen fibre separation⁵. These combined processes ultimately contribute to cervical softening and readiness for labour.The Bishop score is a clinical tool used to assess cervical ripening, with a score <4 indicating an unfavourable cervix for labour progression. Induction agents are used in such cases to achieve a score >4, ensuring effective cervical ripening^6,7. Pharmacologic methods include prostaglandins (misoprostol, dinoprostone), oxytocin, and other agents like mifepristone and nitric oxide donors. Mechanical methods, such as Foley’s catheter and laminaria tents, and complementary methods like nipple stimulation and acupuncture, also aid induction. These interventions facilitate cervical changes, allowing the cervix to shorten, thin, and dilate for successful labour induction^8.9,10.Labour induction is indicated in late preterm, early term, late-term, and post-term pregnancies based on obstetric and medical history^11-15. The goal of IOL is to stimulate cervical ripening, initiate uterine contractions, and facilitate vaginal delivery while minimizing the need for Caesarean section. Foley’s catheter is a widely used mechanical method that promotes cervical dilation and endogenous prostaglandin release. Studies suggest that larger balloon inflation volumes (30-60 mL) may shorten the induction-to-delivery interval without increasing the Caesarean section rate.Castor oil, derived from the Ricinus communis plant, is used in some regions to induce labour, primarily due to its high ricinoleic acid content. Studies show that over 50% of women who consumed castor oil entered active labour within 24 hours, compared to only 4% in the control group. Ricinoleic acid stimulates intestinal smooth muscle and activates prostaglandin E2 (EP3) receptors, influencing both intestinal motility and uterine contractions^16-17.

AIM

The aim of study is to compare effectiveness of foleys catheter v/s castor oil for cervical ripening and labor induction in multigravida patients.

This randomized controlled and observational clinical study was conducted at the Department of Obstetrics and Gynecology, Mathura Das Mathur Hospital, attached to Dr. S. N. Medical College, Jodhpur, Rajasthan, India. The study was carried out after obtaining institutional ethics committee approval and continued until the required sample size was achieved. The study population included multigravida patients admitted to the labour room at MDM Hospital. Patients were randomly assigned to two groups using a computerized randomization technique: Group A (Foley’s catheter group) and Group B (Castor oil group), with a sample size of 16 in each group, rounded to 40 per group. Sample size calculation was performed with an alpha error of 0.05 and study power of 80%, using the formula for hypothesis testing for two independent population proportions. Inclusion criteria included multigravida patients with singleton pregnancy at term, cephalic presentation, and a Bishop score of ≤4. Exclusion criteria comprised placenta previa/vasa previa, malpresentations, scarred uterus, active genital infection, antepartum haemorrhage, premature rupture of membranes (PROM), prolapsed umbilical cord, and previous pelvic surgeries such as VVF/RVF repair, pelvic floor repair, or third-/fourth-degree perineal tear repair.

N= [Z1-∝/22P(1-P)+Z1-βP11-P1+P21-P2 ]2(P1- P2)2

Where,

N = Sample size

Z1-∝/2 = Standard normal deviate for Type 1 error (taken as 1.96 for 95% confidence level or alpha error 0.05)

Z1-β = Standard normal deviate for Type 2 error (taken as 0.84 for 80% study power)

P1 = proportion of improvement in bishops score in group A (Foleys catheter group) [taken as 58% as per finding of Taani et al.]47

 P2= proportion of improvement in bishops score in group B (Castor oil group) [taken as 91 %  as per finding of Gilad et al.]40

P = (P1 + P2)/2

Sample size was calculated to be a minimum of 16 subjects. Considering 10% attrition rate, Sample size was increased and rounded off to 40 subjects in each group.

Table: 1 distribution according to age

The table compares the age distribution of two groups, A and B, with Group A having a higher percentage (87.5%) of participants aged 21-30 years compared to Group B (65%). Group A has a mean age of 28.20 years (SD 3.82), while Group B has a mean age of 29.35 years (SD 5.10). The p-value of 0.9988 indicates no significant difference between the groups' ages.

Table: 2 distribution according to Indication of Induction

The table outlines the indications for induction in groups A and B. Group A has participants with GDM (5%), HDOP (7.5%), IUGR (10%), oligohydramnios (10%), postdated (65%), and pre-eclampsia (2.5%). Group B has participants with GDM (7.5%), HDOP (12.5%), oligohydramnios (12.5%), postdated (65%), and pre-eclampsia (2.5%), but no cases of IUGR. The p-value of 0.4423 suggests no significant difference in the indications for induction between the two groups

Table: 3 distribution according to use of oxytocin

The table compares the use of oxytocin in groups A and B. In Group A, 72.5% did not receive oxytocin, while 27.5% did. In Group B, 42.5% did not receive oxytocin, while 57.5% did. The p-value of 0.0066 indicates significant difference in oxytocin use between the two groups.

Table: 4 distribution according to mode of delivery

The table shows the mode of delivery in groups A and B. In Group A, 10% had lower segment cesarean sections (LSCS) and 90% had normal vaginal deliveries (NVD). In Group B, 32.5% had LSCS and 67.5% had NVD. The p-value of 0.013 indicates significant difference in the mode of delivery between the two groups.

Table: 5 distribution according to indication for LSCS

The table details the indications for lower segment cesarean section (LSCS) in groups A and B. In Group A, 2.5% were due to CPD, 2.5% due to DTA, 7.5% due to fetal distress, and 2.5% due to MSL, with 85% not requiring LSCS. In Group B, 5% were due to DTA, 5% due to fetal distress, and 12.5% due to MSL, with 77.5% not requiring LSCS. The p-value of 0.2987 indicates no significant difference in LSCS indications between the two groups.

GRAPH: distribution according to maternal  and fetal complications

In Group A, 2.5% of mothers experienced fever and vaginal bleeding, while 95% had no complications, whereas in Group B, 10% had diarrhea, 7.5% had nausea, 5% had vomiting, and 87.5% had no complications, with a significant p-value of 0.038. Fetal complications showed no significant difference (p=0.238), with 2.5% in Group A experiencing birth asphyxia and MAS, while in Group B, 2.5% had birth asphyxia and TTN, 5% had MAS, and 90% had no complications.

Table: 6 Time interval of induction of labor and delivery

The table compares the induction-to-labor and induction-to-delivery intervals between groups A and B. Group A has a mean induction-to-labor interval of 7.11 hours (SD 2.61) and a mean induction-to-delivery interval of 12.96 hours (SD 4.79). Group B has longer intervals, with a mean induction-to-labor interval of 9.83 hours (SD 3.10) and a mean induction-to-delivery interval of 16.69 hours (SD 5.23). The p-value of 0.0001 indicates a significant difference between the two groups for both intervals.

Table: 7 Comparison of BISHOP Score.

The table compares the BISHOP scores at different time intervals between groups A and B. At 0 hours, Group A has a mean BISHOP score of 3.3 (SD 0.46), while Group B has a mean score of 3.4 (SD 0.50), with a p-value of 0.3548. At 6 hours, Group A has a mean score of 8.075 (SD 1.91) compared to Group B's 7.45 (SD 1.50), with a p-value of 0.1076. At 12 hours, Group A has a mean score of 10.1 (SD 1.28) and Group B has 9.35 (SD 1.4), with a p-value of 0.0145, indicating significant differences between the groups at these intervals.

Induction of labor” describes the artificial triggering of uterine contractions with the aim of initiating labor and hence delivery in order to reduce maternal or neonatal morbidity and mortality. Before induction of labor, prior cervical ripening enables the risk of Cesarean section to be reduced for a Bishop score ≤ 6. Among the various methods for cervical ripening, Mechanical methods such as the balloon catheter appear to induce fewer contractions but with a longer time of labor, comparable rate of vaginal deliveries, and have a similar rate of maternal or fetal complications¹⁸.

The mean age of women in Foleys catheter group is 28.20 years with majority (87.5%) of participants aged 21-30 years, while mean age of Castor oil group is 29.35 years with majority of women are in age group 21-30 years (65%). We found statistically no significant difference in age between two groups. Gu et al¹⁹ conducted a study on Foley Catheter for Induction of Labor and in their study mean age of women was 28 years.

In our study the most common indication for induction is postdated pregnancy followed by oligohydramnios, HDOP, pre-eclampsia and IUGR. After indication for induction we found that in group-A only 27.5% had given oxytocin while in group-B 57.5% women had given oxytocin. And, this difference is found to be statistically significant (0.0066). We also found that compared to Group-B, the number of C-section is significantly low (p-value 0.013) in group-A (10% versus 32.5% in group-B). The most common indication for C-section in group-B is MSL followed by Fetal distress and DTA, while in group-A only 2.5% had MSL. In study by Okoro et al²⁰ measured the effects of a single oral dose of castor oil (60 mL) on labor induction. Labor induction 24 hours after the intervention occurred in 57% of individuals in the intervention group and 4% of those in the control group. The rate of delivery 48 hours after the intervention was 48.6% in the intervention group and 21.7% in the control group. The proportion of women requiring formal induction of labor with misoprostol or oxytocin was significantly lower in the intervention group than in the control group (17.1% vs 41.5%). Individuals in the intervention group were less likely to have their labor augmented with oxytocin than those in the control group (47.1% vs 71.0%).

Along with this, we found that maternal complication like Diarrhea, nausea and vomiting are very high in group-B. In group-A only 2.5% women have fever and vaginal bleeding.

In this study we found that number of foetal complication in Group-A is 5% (birth asphyxia and MAS in 2.5% each), while in Group-B we found foetal complication in around 10% (birth asphyxia, MAS and TTN). Although, complication is more in Group-B but we found no statistical difference between two group (p-value 0.238). Similarly, ratio of NICU admission is high in Group-B (12.5%) as compared to Group-A (5%). Her, also we found no statistical significance between two groups with respect to NICU admission (p-value 0.235).

In our study we found that Induction to labour interval and induction to delivery interval is significantly low in Group-A compared to Group-B. we also found statistically no significant difference in BISHOP at 0 hour and 6 hours but found a statistically significant difference in at 12 hours with high score in Group-A compared to group-B (p-value 0.0145).

Uterine contractions before the onset the spontaneous labor is indicated in cases where the benefits of giving birth outweigh the benefits of prolonged pregnancy. Cervical ripening before the induction of labor and termination of pregnancy at different gestation periods reduces maternal and foetal complications including the need for caesarean section. In our study we found that requirement of oxytocin, number C-section, induction-to-labor and induction-to-delivery intervals, maternal complication, fetal complication are lower in women who used Foleys catheter compared to women whom given Castor oil for cervical ripening and labor induction. The present trial, which suggested that Foley catheter could be safely used in cervical ripening for both obstetrical and medical indications. 

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