ORIGINAL ARTICLE
THE STUDY OF INTRA-CERVICAL FOLEYS CATHETER AND PGE2 GEL IN A RURAL SETUP.
Charanjeet Kaur1, Savita Jha2, Amandeep Singh Kaloti3
HOW TO CITE THIS ARTICLE:
Charanjeet Kaur, Savita Jha, Amandeep Singh Kaloti. “The study of intra-cervical foleys catheter and PGE2 gel in a rural setup”.Journal of Evolution of Medical and Dental Sciences 2013; Vol2, Issue 51, December 23; Page: 9966-9970.
ABSTRACT: AIM: The outcome of induction of labour depends on the status of cervix at the time of induction. OBJECTIVE: To compare PGE2 gel and intra – cervical Foley’s Catheter for pre – induction cervical ripening. STUDY DESIGN: A randomized prospective study was conducted in the Department of OBGY, at SGT Medical College Budhera, Gurgaon from July 2010 to December 2012. 800 Patients at with a Bishop’s score<3 with varied indication for induction were randomly selected to recieve intracervical PGE2 gel (400 patients) or Foley’s catheter (400 patients). Bishop’s score was reassessed after 6 hrs following induction & augmentation of labour was done if required. Chi square test and t – test were used for statistical analysis. RESULT: The two groups were compared with respect to maternal age, gestation age, induction of labour & initial Bishop’s score. The change in Bishop Score for Foley’s Catheter & PGE2 gel was 5.56 ± 1.82 respectively, P< 0.001, which was statistically significant. But there was no significant difference between the two groups. The difference in side effects is not statistically significant. 56 caesarean sections (14%) was performed in group A & 74 (18.5 %) were performed in group B (not significant). The induction to delivery interval was 15.32 ± 5.24 hrs in group A and 14.2 ± 5.14 hrs in group B (P=0.291). Apgar scores, birth weights and MICU admissions showed no diffidence between the two groups. CONCLUSION: The study shows that loch Foley’s Catheter and PGE2 gelare equally efficient in pre-induction cervical ripening.
INTRODUCTION: Cervical ripening is a prelude to the onset of labour whereby the cervix becomes soft and compliant. It is assessed using the Bishop score(1).Patients with a poor Bishops score <3 usually have higher rates of failure of induction (2).
Cervical repairing by physical or pharmacological interventions helps to decrease the induction failure (1, 2).
The aim of the study was to compare the efficacy of Foley’s Catheter with PGE2 gel for pre-induction cervical repining. The induction delivery interval, maternal and fetal outcomes and the need for augmentation of labour in the two groups were also compared.
MATERIALS AND METHODS: The study was conducted at SGT Medical College Budhera, Gurgaon in the Department of OBGY from July 2010 to December 2012.
A total of 800 patients with various indications for induction of labour were included after a written, valid consent.
INCLUSION CRITERIA:
PRIMIGRAVIDA,
GESTATIONAL AGE 37 > OR= WEEKS
SINGLETON PREGNANCY
CEPHALIC PRESENTATTION
BISHOPS SCORE ≤ 3
INTACT MEMBRANES.
EXCLUSION CRITERIA:
MULTIPLE PREGNANCIES
ABSENT MEMBRANES
MAL – PRESENTATION
APH
MEDICAL DISORDERS e.g. Diabetes, heart disease, renal disease.
Detailed history and examination was noted.
The Bishops score was assessed.
The patients randomly received Foley’s Catheter (Group A, n = 400) or PGE2 gel (Group B, n = 400).
Cervical status was reassesed 6 hours post-induction.
Demographic profile, gestational age, improvement of Bishops & score, induction-delivery interval was noted.
PGE2 gel was repeated for patients whose post-induction Bishops score was ≤ 6 in both the groups.
Labour was augmented by ARM/+oxytocin administration if required.
Patients who did not enter active phase of labour within 24 hrs of induction were labelled as failure of induction.
Students t test & chi square test were used for statistical analysis. Differences with a P value of < 0.05 were considered statistically significant with the confidence limit of 95% (power of test 80%).
RESULTS: Two groups A and B were allocated 400 randomized patients each. Both the groups were comparable with respect to the maternal age, gestational age, indication for induction and pre – induction Bishops score (Tables 1, 2).
Variable / Group A(n = 200) / Group B
(n = 200) / P
Maternal age / 22.27+- 2.97 / 22.00+-2.79 / 0.079
Gestation age / 38.7+- 1.73 / 38.9+-1.68 / 0.11
Indication for induction
PIH / 148(74%) / 146 (73%) / -
Post – datism / 118 (59%) / 124 (62%) / -
IUGR(intra uterine growth retardation) / 20 (10%) / 22 (11 %) / -
Oligohydraminos / 20 (10%) / 02 (1%) / -
IUFD(intra uterine fetal death) / 26 (13%) / 34 (17%) / -
Others / 68 (34%) / 72 (32%) / -
Mean pre-induction score / 1.48±0.67 / 1.59±0.78 / >0.005
Table 1: Demographic Profile
No statistically significant difference was demonstrated between the two groups.
Bishop Score / Group A(n = 200 / Group B
(n = 200
Mean pre-induction score / 1.48 ± 0.67 / 1.59 ± 0.78
Mean Post-induction score / 7.04 ± 7.08 / 7.08 ± 1.87
Mean Change in Score / 5.56 ± 1.89 / 5.49 ± 1.82
t = 20.91 / t = 40.17
P < 0.0001 / P ≤ 0.0001
Table 2: Change in Bishop Score.
In this study improvement in the Bishops score in group A was 5.56 ± 1.89 (Mean ± SD, P<0.001) and in GROUP B it was 5.49 ± 1.82 (Mean ± SR, P<0.001), however no significant difference in the mean changes in two groups could be established (TABLE 3).
Mode of delivery / Group A(n = 200 / Group B
(n = 200 / P Value
X2 = test
Spontaneous / 100 (50%) / 116(58%) / X2 = 4.45
ARM / 32 (16%) / 40(20%) / df2
Oxytocin / 148(74%) / 160(80%) / P = 0.21
ARM + Oxytocin / 120(60%) / 84(42%)
Total / 400 / 400 / 800
Table 3: Need for augmentation
No significant difference in need for augmentation in both groups.
The need to further argument labour was studied.
100(25 %) patients in group A and 116(29%) patients in group B went into spontaneous labour.
In Foley’s catheter group, augmentation of labour was required by doing ARM (in 32), oxytocin infusion (in 148) and both ARM + oxytocin in 120 patients.
In PGE2 gel group, 40 patients required ARM,160 patients required oxytocin and 84 patients required both ARM + oxytocin.
The need for augmentation of labour in the two groups was not statistically significant.
TABLE 4 Shows that there was no statistically significant differences in spontaneous vaginal delivery in both the groups.
Groups A had 82% (n=328) and group B has 78.5% (n=314) spontaneous deliveries.
L.S.C.S. was done for fetal distress in 17 patients in group A and 21 in group B.
The other indication for LSCS were failure to progress (20 and 26 respectively) and failure of induction (2 and 6 respectively).
The need for LSCS was not significant in both the groups.
Variable / Group A(n = 200 / Group B
(n = 200 / P Value
Spontaneous / 328 (164%) / 314 (157%) / X2 = 1.68
Instrumental / 16 (8%) / 12 (6%) / df2
LSCS / 56 (28%) / 74 (37%) / P = 0.438
Total / 400 / 400 / -
Induction-delivery / 15.32 ± 5.24 / 14.2 ± 5.14 / t = 1.059
Interval / - / - / P =0.291
Table 4: Mode of deliver and induction – delivery interval
TABLE 5 Shows that the incidence of perinatal asphyxia with APGAR score ≤ 7 at 5 min and meconium aspiration syndrome were similar in both groups.
18.5 % of babies in group A (n = 74) and 21% of babies in group B (n = 84) required NICU admission.
The perinatal morbidity in both the groups was not statistically significant.
Variable / Group A(n = 200 / Group B
(n = 200 / P Value
Meconium Aspiration Syndrome(MAS) / 18 / 22 / .0.005(NS)
LSCS for Fetal Distress / 34 / 42 / -
1 min Apgar ≤ 7 / 40 / 44 / -
5 min Apgar ≤ 7 / 30 / 32 / -
NICU admission / 74 / 84 / -
Neonatal deaths / 14 / 18 / -
Table 5: Neonatal outcome
DISCUSSION: The study confirmed that both Foley’s Catheter & PGE2 gel are equally effective in pre – induction cervical repining. The mean change in Bishops score in Foley’s Catheter 5.56 ± 1.89 (P<0.0001) and PGE2 gel 5.49 ± 1.82 (P<0.0001) were highly significant. However, a comparison between the two groups showed that one method did not confer a statistically significant advantage over the other.
There was no infections related morbidity with the use of Foley’s Catheter as also stated by St.Onge and Conners(2) and Anthony et al(4).
The mean induction delivery interval was 15.32 hrs in Foley’s group and 14.2 hrs in PGE2 group which was not statistically significant. Similar observations were observed by Dewan et al(3). 14% patients in group A and 18.5% in group B required LSCS which is similar to those of St.Onge and Conners(2) and Anthony et al(4).
It was observed that use of Foley’s catheter & PGE2 was not associated with increased rate of caesarean section.
Neonatal outcome data showed that there was no significant difference with respect to MAS (18 and 22 respectively), 1 min APGAR score <7 (30 and 32 respectively), MICU admission (74 and 84 respectively), in the two groups.
The total cost of Foley’s catheter was much less than PGE2(3, 4).
CONCLUSION: The study has revealed that there is no significant difference in the efficacy of intra-cervical Foley’s catheter or PGE2 gel for pre-induction cervical ripening. The other variables like induction delivery interval, need for augmentation and maternal and neonatal outcome were similar in both the groups.
REFERENCES:
- National Institute for Clinical Excellence. Clinical guidelines for induction of labour, Appendix-E, LONDON: NICE; 2001.
- St. Onge RD, Conners GT. Preinduction cervical ripening: a comparison of intracervical PGE2 gel vs. the Foley catheter. AM J Obstet Gynecol. 1995; 172:687-90.
- Dewan F, Ara AM, Begum A. Foley’s `catheter versus prostaglandin for induction of labour. Singap J Obstet Gynaecol. 2001;32: 56-63.
- Anthony C, Sciscione DO, Helen M, et al. A prospective, randomized comparison of Foley catheter insertion vs. intracervical PGE2 gel for preinduction cervical ripening. Am J Obstet Gynecol. 1999;180:55-9.
Journal of Evolution of Medical and Dental Sciences/ Volume 2/ Issue 51/ December 23, 2013 Page 1