COMPARISON OF INDUCTION OF LABOR WITH FOLEY CATHETER AND PROSTAGLANDINS IN POSTDATE PREGNANCIES.
Objective: To compare the success of Foley catheter and prostaglandin E2 (PGE2) in females presenting with postdates pregnancy.
Study Design: Randomized controlled trial.
Place and Duration of Study: Department of obstetrics and gynecology, Combined Military Hospital (CMH), Quetta Jun 2015 to Oct 2015.
Material and Methods: Through non-probability, consecutive sampling technique 150 cases were included in the study. Informed consent and demographic details were noted. All females were randomly divided in two equal groups by using lottery method. In group A, Foley catheters, were administered. Speculum examination was performed, and 16F standard latex Foley catheter was inserted, using aseptic technique, above the internal cervical os and inflated with 30 mL of sterile water. The catheter was taped to the inner thigh with slight traction, and spigot inserted to occlude the lumen. In group B, PGE2 gel was inserted into the posterior vaginal fornix. Initially 2 mg dose per vaginum for nulliparous and 1 mg per vaginum for multi parous women was used. A post-insertion cardiotocography (CTG) was performed for at least 30 minutes. The cervix was re-examined after six hours and, if required, the procedure repeated using a further 1 mg PGE2 (regardless of parity).
Success was labelled for those females who delivered vaginally within 24 hours. Statistical analysis was performed using SPSS version 16. Both groups were compared for success in terms of vaginal delivery within 24 hrs by using chi-square test. A p-value [?]0.05 was taken as significant.
Results: The mean age of the patients was 28.33 +- 5.79 years, the mean gestational age was 42.00 +- 0.82 weeks. Success was achieved in 76 cases in which 26 were from group A and 50 were from group B. Statistically highly significant difference was found between the study groups and success of the patients i.e. p-value=0.000. Conclusion: PGE2 showed significantly greater success in terms of vaginal delivery within 24 hrs as compared to Foley catheter in females presenting with postdates pregnancy.
Keywords: Amniotic fluid, Foley's catheter, Induction of labor, Postdate pregnancy, Prostaglandin E2.
Pregnancy beyond 42 weeks or 294 days often invokes maternal concern about delay past the expected date of delivery. The incidence of postdate pregnancies is between 4-14%. Post-mature births can carry risks for both the mother and the infant, including fetal malnutrition which increases perinatal mortality1.
Postmaturity is the condition of a baby that has not yet been born after 42 weeks of gestation, two weeks beyond the normal 40 weeks. Weeks post-term, postmaturity, prolonged pregnancy, and post-dates pregnancy all refer to postmature birth2.
The most common cause of prolonged pregnancies is inaccurate dating. The use of standard clinical criteria to determine the estimated delivery date (EDD) tends to overestimate gestational age and consequently increases the incidence of postterm pregnancy. Clinical criteria which are commonly used to confirm gestational age include last menstrual period (LMP), the size of the uterus as estimated by bimanual examination in the first trimester, the perception of fetal movements, auscultation of fetal heart tones, and fundal height in a singleton pregnancy3.
When postterm pregnancy truly exists the cause is usually unknown. Common risk factors include primiparity, previous postterm pregnancy, male fetus, obesity, hormonal factors and genetic predisposition. It is not known how body mass index (BMI) affects the duration of pregnancy and timing of delivery, but interestingly obese women have a higher incidence of postterm pregnancy, while women with low BMI have a higher incidence of preterm labour (delivery before 37 weeks of gestation)3.
Induction of labour is the intentional or artificial initiation of cervical ripening and uterine contraction for the purpose of accomplishing delivery, prior to onset of spontaneous parturition. Induction of labor is indicated where the benefits to mother or to the fetus outweighs the benefit of continuing pregnancy4-6.
In postdates, different procedures could be performed for induction of labor. Vaginal prostaglandins E2 are effective whatever the cervical conditions. Insertion of catheter is a reliable method without any pharmacological effect. It opens interesting perspectives but with caution about the possibly increased risk of infections. A Foley catheter is a flexible tube passed through the urethra and into the bladder to drain urine. It is the most common type of indwelling urinary catheter7. The mechanical action of the Foley catheter strips the fetal membranes from the lower uterine segment and causes rupture of lysosomes in the decidual cells, part of which is phospholipase A. These lytic enzymes act on phospholipase to form arachidonic acid which is converted to prostaglandin, thereby improving the consistency and effacement of the cervix. The advantage of this method over the pharmacological preparation includes simplicity of preservation, lower cost and reduction of side effects8.
The rationale of this study was to compare the success of Foley catheter and prostaglandin E2 (PGE2) in females presenting with postdates pregnancy. It has been noticed in routine as well as through literature that PGE2 is a more effective method for induction of labor and has benefits in terms of early spontaneous delivery without compromising the health of fetus and mother. But we have also observed that there is controversy in results of already conducted studies and the studies which have been mentioned above were conducted on small sample size. So we intend to find a more suitable and beneficial method of induction of labour and to conduct this study on a larger sample size in order to make this study more reliable. Our study will help us in implementing a more suitable method for induction of labour.
MATERIAL AND METHODS
This randomized controlled trial was conducted at the department of obstetrics and gynecology, Combined Military Hospital (CMH) Quetta from, June 2015 to October 2015. Sample size of 150 cases; 75 cases is calculated with 80% power of test, 5% level of significance and taking expected percentage of success i.e. 60% with Foley catheter and 37.1% with PGE2 in females presenting with postdates pregnancy. Non probability, consecutive sampling was used. Pregnant women aged 20-40 years of parity <5 presenting with postdates pregnancy (as per operational definition) with Bishop Score <6 were included in the study.
While exclusion criteria was multiple pregnancies or non-cephalic presentation (on USG), females with hypertension (BP [greater than or equal to]140/ 90 mmHg) or hypotension (BP 1.2 mg/dl), or deranged hepatic function (AST >40 IU, ALT >40 IU), cardiac diseases (abnormal ECG and medical record), history of severe asthma, palpitation, anemia (Hb 0.05)14. Ezimokhai and Nwabinelli found that ripening effect of a Foley catheter on the cervix in 21 primigravida to be similar to that of 5 mg of PGE2 in vaginal gel in 14 primigravida15.
Deshmukh et al showed that for pre-induction cervical ripening there is no difference in efficacy between intra cervical PGE2 gel or intra cervical Foley catheter. Also, other factors like induction-delivery interval, maternal and neonatal outcome and need for oxytocin for further augmentation were similar in both the groups16.
Another found that the Foley catheters are efficacious with a shorter induction to-delivery time than PG for induction of labor with an unfavorable cervix17.
Both agents have similar CS rates, but Foley catheters result in increased need for oxytocin stimulation and there is more tachysystole with PG18.
One randomized controlled trial reported that in women with an unfavorable cervix at term, induction of labor with a Foley catheter is similar to induction of labor with prostaglandin E2 gel, with fewer maternal and neonatal side-effects19. A clinical study by Rashid et al20. Found favorable and beneficial effect of Foley catheter. Vaknin et al21 performed a meta-analysis comparing the efficacy and safety of cervical ripening and labour induction by Foley catheter balloon versus locally applied prostaglandin in third trimester of pregnancy.
PGE2 showed significantly greater success in terms of vaginal delivery within 24 hrs as compared to Foley catheter in females presenting with postdates pregnancy.
CONFLICT OF INTEREST
This study has no conflict of interest to declare by any author.
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18. Vaknin Z, Kurzweil Y, Sherman D. Foley catheter balloon vs locally applied prostaglandins for cervical ripening and labor induction: a systematic review and metaanalysis. Am J Obstet Gynecol 2010; 203(5): 418-29.
19. Jozwiak M, Rengerink KO, Benthem M, van Beek E, Dijksterhuis MG, de Graaf IM, et al. Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial. The Lancet 2012; 378(9809): 2095-103.
20. M. Rashid, A. Begum, S. B. Chowdhury , S. Chowdhury, "Induction of Labor by Foley's Catheter Method. A Clinical Study of Forty Cases," J Obstet Gynaecol Bangladesh 1994; 9(1): 16-21.
21. Kurzweil Y , Sherman D, "Foley Catheter Balloon vs Locally Applied Prostaglandins for Cervical Ripening and Labour Induction: A Systematic Review and Metaanalysis," Am J Obstet Gynecol 2010; 203(5), 418-29.
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|Publication:||Pakistan Armed Forces Medical Journal|
|Article Type:||Clinical report|
|Date:||Apr 30, 2017|
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