Comparative study of combination of Foley’s bulb and vaginal misoprostol versus vaginal misoprostol alone for cervical ripening and induction of labour at a tertiary hospital

 

 

Abstract              Background: A variety of methods have been used for cervical ripening or induction of labour. Such as mechanical methods (membrane striping, mechanical dilators, hygroscopic dilators, laminaria tents and foleys balloon catheter), medical methods (oxytocin, dinoprostone, misoprostol, mifepristone, nitric oxide donors, estrogen) and surgical method (amniotomy). Present study was aimed to evaluate combination of foley bulb with intravaginal misoprostol versus intravaginal misoprostol alone in cervical ripening and induction of labour at a tertiary hospital. Material and Methods: Present interventional, randomized prospective study was conducted in pregnant women with term singleton pregnancy, cephalic presentation, viable gestation, intact membranes and unfavorable cervix i.e. bishop score less than 6, planned for induction of labour. 200 patients were randomly divided into 2 groups as patients induced with catheter and misoprostol (Group A) and patients induced with misoprostol (Group B). Results: In present study 70% patients in Group A and 82% percent of patients in Group B were from age group of 21-30 years. Both the groups were comparable in terms of maternal age, mean gestational age and distribution of multigravida and primigravidae. (p < 0.05). Mean preinduction Bishop score was 2.48± 0.78 in group A and 2.37±0.8 in Group B and difference was statistically insignificant. (p=0.246). Mean Bishop score after induction of labour was 6.15 and 6.49 in Group A and B respectively and the difference was statistically significant (p=0.04). Mean change in Bishop score was 3.67 ± 1.25 in Group A and 4.12± 1.02 in Group B. Both the groups were compared statistically (p=0.006). Mean duration of induction to active phase of labour was 10.65±0.95 and 12.31±1.81 in Group A and B respectively and difference was statistically significant (p=0.001). The number of patients delivered vaginally were 87% in Group A and 89% in Group B. 13% patients had undergone lower segment caesarian section in group A and 11% in Group B. The results were found to be statistically insignificant (p=0.663). Conclusion: Combination of catheter and vaginal misoprostol seems to be faster and better method than vaginal misoprostol alone for induction of labor, effective in shortening induction to delivery interval and requires minimum number of doses of misoprostol.               

Keywords: induction of labour, primigravida, intracervical foley catheter, intravaginal misoprostol

 

INTRODUCTION

Labour is the process by which the fetus, after the period of viability is expelled from the genital tract to the outer world.¹ Labour induction is one of the most common procedures performed in Obstetrics, reaching 10 - 20% of deliveries worldwide, but its success depends largely on the condition of the cervix.² Common indications of labor induction are hypertensive disorders of pregnancy, post-dated pregnancy, premature rupture of membranes, intrauterine growth restriction, fetal complications (isoimmunization, oligohydramnios, non-reassuring fetal heart status, intrauterine fetal death) and maternal medical complications (diabetes mellitus, renal disease, chronic pulmonary disease).^1,3 Cervical ripening refers to the process of preparing the cervix for labor induction by promoting dilatation and effacement. A variety of methods have been used for cervical ripening or induction of labour. Such as mechanical methods (membrane striping, mechanical dilators, hygroscopic dilators, laminaria tents and foleys balloon catheter), medical methods (oxytocin, dinoprostone, misoprostol, mifepristone, nitric oxide donors, estrogen) and surgical method (amniotomy).⁴ The present study was aimed to evaluate combination of foley bulb with intravaginal misoprostol versus intravaginal misoprostol alone in cervical ripening and induction of labour at a tertiary hospital.

              

MATERIAL AND METHODS

Present study was conducted in Post Graduate Department of Obstetrics and Gynaecology, S.M.G.S. Hospital, Jammu over a period of one year from November 2018 to October 2019, after approval from Hospital Ethical Committee. Present study design was interventional, randomized prospective study

INCLUSION CRITERIA: Pregnant women with term singleton pregnancy, cephalic presentation, viable gestation, intact membranes and unfavourable cervix i.e. bishop score less than 6, planned for induction of labour, willing to participate in the study.

EXCLUSION CRITERIA: Pregnant women with previous LSCS, placenta previa, chorioamnionitis, previous uterine surgeries like myomectomy, fetal malpresentation, multifetal gestation. Fetal demise, Fetal growth restriction. Contraindication to prostaglandins

An informed and written consent was taken from each patient for inclusion into the study. 200 patients were randomly divided into 2 groups as patients induced with catheter and misoprostol (Group A) and patients induced with misoprostol (Group B).

Group A - in 100 patients, under all aseptic precaution 16F foley catheter was inserted through internal cervical ostium. Foley’s catheter then inflated with 50 ml of normal saline. Catheter was then pulled against os and taped to inner side of the thigh. Simultaneously 25µg of misoprostol was kept per vaginum every four hourly for a maximum of 6 doses. Catheter was removed after 12 hrs. or earlier if patient went in active labour.

Group B - In 100 patients, 25 µg of misoprostol was kept per vaginum in the posterior fornix every four hourly for a maximum of 6 doses, till cervix became favourable or patient went in active labour, when required intravenous oxytocin was started 4 hrs. after the last dose of misoprostol at a rate of 2 milliunits per minute and subsequently increased by 2 milliunits every 30 minutes. Partogram was maintained throughout the labour.

The two groups were then compared with respect to change in bishop score, total duration of labour, induction to active phase of labour, induction to delivery interval, intrapartum complications (tachysystole, chorioamnionitis), mode of delivery, fetal outcome at birth, APGAR score and postpartum complications. The data was entered in MS EXCEL spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) version 21.0. Categorical variables were presented in number and percentage (%) and continuous variables were presented as mean ± SD and median. Quantitative variables were compared using Mann-Whitney Test between the two groups. Qualitative variables were correlated using Chi-Square test. A p value of <0.05 was considered statistically significant.

DISCUSSION

Induction of labour is an integral component of all maternity practices and is important as patients spend more than 24 hours in this process. Therefore, in this study we compared the efficacy and safety of vaginal misoprostol in combination with transcervical foley’s catheter versus vaginal misoprostol alone. The mean age of patients in Group A was 24.81±4.24. However it was observed to be 25.46±4.05 in Group B, difference was statistically insignificant. In the study done by Santosh et al.,⁵ it was found that the mean age in Group A and Group B was 24.32±3.35 yrs. and 24.35±3.30 respectively. It was analysed and found to be statistically insignificant. Carbone JF et al., ⁶ found that the mean age of patients in Group A and Group B was 25.7±7.2 and 24.2±5.5 respectively and 67% patients in Group A and 65% in Group B were nulliparous patients. The mean gestational age was 39.09±1.03 in Group A and 39.11±0.9 in Group B and difference was statistically insignificant. Santosh et al.,⁵ observed that the mean gestational age in Group A and Group B was 39.069±1.596 and 39.166 ±1.602 respectively and difference was statistically insignificant. In study done by Santosh et al.,⁵ noted that postdatism, antepartum eclampsia and antepartum haemorrhage were the leading indications for induction of labour. Similar findings were noted in present study. In the present Bishop score was better in misoprostol group after induction when compared combination group (foley’s with misoprostol). But misoprostol took more time to change this Bishop score. However in combination group there were two mechanisms working simultaneously to cause cervical dilatation and effacement in inducing labour. Our results were consistent with the studies done by Bhatiyani et al.,⁷ who found that mean Bishop score was more in misoprostol group as compared to combination group but, there was no significant difference in the improvement in Bishop score between the two groups. Kashanian M et al., ⁸ noted that mean change in bishop score was more in misoprostol group as compared to combination group (catheter with misoprostol). Similar findings were noted in present study. The combination group acts by additive action of mechanical as well as pharmacological ripening of cervix and leads to faster dilatation of cervix. Combination group had less induction to active phase interval than misoprostol only group. The combination group leads to 1.66 hours shorter induction to active phase interval when compared with misoprostol only group. Therefore, use of combination of catheter with vaginal misoprostol is better than vaginal misoprostol only for induction of labour. Our results were consistent with the studies done by Hussein M et al.⁹ We found that mean induction to delivery interval was shorter in combination group by a mean of 3.47 hours when compared with those induced with misoprostol group, the difference being statistically significant. The results were consistent with the other studies.^5,6,9 On the contrary Kashanian M et al.,⁷ Bhatiyani BR et al.,⁸ found that the duration of induction to delivery interval was faster with vaginal misoprostol alone compared to the combination group. In addition Chung et al.,¹⁰ Rust OA et al.,¹¹ reported no difference in induction to delivery interval between the two groups. They also reported that the addition of mechanical ripening with the trans-cervical foley balloon to intravaginal misoprostol did not improve the efficiency of preinduction cervical ripening . Mechanical and pharmacological cervical ripening agents appear to act independently rather than synergistically. In the present study no intrapartum or postpartum complication was observed in both the groups. Our results were consistent with the finding of Santosh et al.,⁵ who found hypertonic uterine action in 6.12% of the cases in Group A and 5.05% of the cases in Group B. There was no differences in labor complications in both the groups. Santosh et al.,⁵ concluded that the neonatal complications in the form of mild asphyxia were seen in 9.18% of the neonates in Group A and 12.12% of the neonates in group B. Neonatal jaundice was observed in 4.08% of the newborn in Group A and 4.08% in Group B. Around 2% of neonates had hypoglycaemia in both groups. Statistically, there was no difference in adverse neonatal outcome in both the groups. Similar findings were noted in present study.

Limitations of present study were small sample size, lack of a placebo group and lack of blinding after randomization. Multicentric studies with larger number of women are needed to achieve a statistical power sufficient to compare the occurrence of infrequent events.

 

CONCLUSION

Combination of catheter and vaginal misoprostol seems to be faster and better method than vaginal misoprostol alone for induction of labor, effective in shortening induction to delivery interval and requires minimum number of doses of misoprostol. There was no statistically significant difference in the maternal and neonatal outcome when these two methods were used for induction of labour.

 

REFERENCES

1. American College of Obstetricians and Gynecologists (ACOG). Induction of labor. Practice bulletin no. 107. Obstet and Gynecol 2009; 114:386-97.
2. Guerra GV, Cecatti JG, Souza JP, Faundes A, Morais SS, Gulmezoglu AM et al. Factors and outcomes associated with the induction of labour in Latin America. BJOG. 2009; 116:1762-772.
3. Ande AB, Ezeanochie CM, Olagbuji NB. Induction of labor in prolonged pregnancy with unfavourable cervix:comparison of sequential intracervical Foley’s catheter with intravaginal misoprostol and misoprostol alone. Arch Gynaecol Obstet 2012; 285(4):967-71.
4. Chen W, Xue J, Peprah MK, Wen SW, Walker M, GaoY et al. A Systematic review and network metaanalysis comparing use of foley’scatheter, misoprostol and dinoprostone for cervical ripening and induction of labour. BJOG: Int J Obstet and Gynaecol 2016; 123(3):346-54.
5. Santosh, Kour P, Kour A, Kour M, Garg R. A comparative study of combination of intracervical foley’s catheter and intravaginal misoprostol versus intravaginal misoprostol alone for induction of labour. Ind J Obstet and Gynecol Research 2018; 5(1):131-35.
6. Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction - a randomized controlled trial. Obstet Gynecol 2013; 121(2 pt 1):247-52.
7. Bhatiyani BR, Gandhewar MR, Kapsikar S, Gaikwad P. A study comparing vaginal misoprostol alone with vaginal misoprostol in combination with Foley catheter for cervical ripening and labour induction. Int J Reprod Contracept Obstet Gynecol 2017; 6:485-88.
8. Kashanian M, Akbarian AR, Fekrat M. Cervical ripening and induction of labor with intravaginal misoprostol and foley catheter cervical traction. Int J Gynecol Obstet 2006; 92:79-80.
9. Hussein M A comparative study between vaginal misoprostol and a combination of misoprostol and Foley catheter for cervical ripening and labour induction in early third trimester pregnancy. J Egy Society of Obstet and Gynecol 2007; 33:10-12.
10. Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective randomised controlled trial that compared misoprostol, Foley catheter and combination misoprostol with foley catheter for labour induction. Am J obstet Gynecol 2003; 189:1031-035.
11. Rust OA, Greybush M, Atlas RO, Jones KJ, Balducci J. Preinduction cervical ripening a randomized trial of intravaginal misoprostol alone and combination of transcervical Foley balloon and intravaginal misoprostol. J Reprod Med 2001; 46(10):899- 904.
    
    

 

 

 

 

 

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