Randomized Control Study of Foley bulb and Vaginal
Indian Journal of Public Health Research & Development, April-June 2018, Vol.9, No. 2 97 Labour induction in the presence of an unfavourable
cervix is associated with an increased likelihood of prolonged labour and an increased incidence of chorioamnionitis and cesarean delivery.5 Various methods of ripening for the unfavourable cervix and induction of labour are being used by many obstetricians, still, the best agent and method for induction of labour remains uncertain. Thus this study was undertaken to evaluate the safety and efficacy of a combination of the Foley bulb and vaginal misoprostol with vaginal misoprostol alone for labour induction.
MeThOdOlOgy
Source of data: A randomized control study of pregnant women in labour attending the hospitals attached to J.J.M. Medical College, Davangere, between November 2014 to September 2016.
MATeRIAl ANd MeThOd
A prospective evaluation of women attending labor room in hospitals attached to J.J.M. Medical College, All gravidae of aged between 19-35 years who fulfill the inclusion criteria were included in the study.
Inclusion criteria: Singleton pregnancies, Vertex presentation, Unfavorable cervix (Bishop Score <6), gestational age greater than 28 weeks gestation,
exclusion criteria: Anomalous fetus. Women with Fetal malpresentation, Multifetal gestation, Fetal demise, Contraindication to prostaglandins, Non- reassuring fetal heart rate tracing, Oligohydramnios, Cephalo Pelvic Disproportion (CPD),Contracted pelvis, Placenta praevia, Previous caesarean delivery or other significant uterine surgery.
One hundred patients were enrolled, 50 in each group. An informed and written consent was taken from each patient. The course of study is explained. All patients underwent nvestigations like complete hemogram, serum proteins, Blood grouping and typing,routine urine examination, HIV test, HbSAg and Obstetric ultrasound.The patients were divided into two groups namely Group A and Group B. Vaginal misoprostol only group (Group A) received 25μg of misoprostol every 4 hours (maximum 6 doses). Once the cervix became favorable or patient is in active labor, misoprostol was discontinued. In the Combined group (Group B) a 16
F foley catheter was inserted through internal cervical os under all aseptic precautions and filled with 50 ml of normal saline. Catheter was then pulled against os and taped to inner side of the thigh. Simultaneously they received 25micrograms of misoprostol per vaginum for every four hours for a maximum of 6 doses. Partograph was maintained throughout the labour. Other aspects of labor management were similar for both groups, including continuous electronic fetal monitoring. In all patients, the cervical status was assessed by using Bishop Score prior to induction. Repeat Bishop Scores were assessed prior to each dose. Following parameters were recorded –number of doses, the interval between induction to onset of uterine contraction, induction-delivery interval, mode of induction-delivery, maternal and neonatal complications and adverse effects of the drug like fever, diarrhea, nausea and others.
Statistical Analysis: Data was analyzed using paired T test and chi-square test.
ReSulTS
Mean age was comparable in both the groups (23.7±3.4 vs 23.7±3.4 years). Postdated pregnancy formed the largest group of indication for induction in either group constituting 42% in misoprostol group and 34% in combination group, followed by gestational hypertension constituting the second major indication for induction in both the groups. There was almost an equal distribution of both primigravida and multigravida patients in both misoprostol and combination group. In misoprostol group full term (FT) pregnancies constituted upto 58% and postdated pregnancies constituted upto 42% of the total.
Where as in combination group, full term pregnancies formed upto 66% of the total and postdated pregnancies formed upto 34% of the total cases.
In present study, 50% of cases required one dose, 24% of cases required two doses, 16% of cases required 3 doses and 10% of cases required 4 doses of intravaginal misoprostol. In combination group, 64% of cases required one dose, 36% of cases required two doses.
P-value was significant (p<0.002) and less number of cases in combination group required more than one dose of misoprostol.
The induction to pain interval ranged from 1-4 hours (2.82±0.77) in misoprostol group and 0.5 – 4 hours (2.55±0.96) in combination group and both were comparable.
98 Indian Journal of Public Health Research & Development, April-June 2018, Vol.9, No. 2 The induction delivery interval ranged from
4.5-32.5 hours with a mean of 12.19±7.22 hours in misoprostol group, while in the combination group it ranged from 4-16 hours with a mean of 7.32±3.26 hours. 5 cases in vaginal misoprostol group and 2 cases in combination group were taken for caesarean section.
There was statistically highly significant difference in induction delivery interval between the misoprostol and combination group. In the present study, 84% of total cases in misoprostol group and 92% of the total cases in combination group had spontaneous vaginal delivery. Full term outlet forceps delivery occurred in 4% of the cases in the misoprostol group as well as in the combination group. Full term vacuum delivery occurred in 2% of the cases in misoprostol group when compared to none in combination group. Caesarean sections were more in misoprostol group (10%) as compared to combination group (4%).Failed induction was present in 6% of the cases in misoprostol group and 2% of the cases in combination group and LSCS was the mode of delivery in failed induction cases..44 of total cases in misoprostol group and 47 of total cases in combination group had clear liquor. 4% of the total cases in misoprostol group and 2% of total cases in combination group had thick meconium stained liquor and babies required NICU care.
8% of the total cases in misoprostol group and 4% of the total cases in combination group had thin meconium stained liquor. The placenta was complete in all the cases in both misoprostol and combination group.
No maternal complication occurred in any case of combination group. Tachysystole occurred in 2% of the total cases in misoprostol group. Fetal distress occurred in 8% of cases in vaginal misoprostol group and 6%
of cases in combination group.6% of the babies in vaginal misoprostol group required NICU care and none required NICU care in combination group. In the present study, initial Bishop Score was 3-4 in 78% of the cases in misoprostol group and 94% of the cases in combination group.66% of the cases in misoprostol group, delivered before T12 and 84% of the cases delivered before T12 in combination group.
dISCuSSION
The induction delivery interval as shown by the previous studies 6-11 was shorter in combination group when compared to misoprostol group alone and it was statistically
significant. In the present study, the
findings correlated with previous studies. It is evident from the previous studies6
,-11, that there is more of vaginal deliveries in combination group when compared to misoprostol group.
In the present study, 84% of the total cases in misoprostol group and 92% of the total cases in combination group delivered vaginally. Full term outlet forceps delivery occurred in 4% of the cases in the misoprostol group as well as in the combination group. Full term vacuum delivery occurred in 2% of the cases in the misoprostol group. Caesarean sections were more in misoprostol group as compared to combination group. Failed induction was present in 6% of the cases in misoprostol group and 2% of the cases in combination group.
In a randomized controlled trial conducted by Carbone et al
11in year 2013, it is seen that major categories for indication for induction were postdated pregnancies, chronic hypertension and pre-eclampsia. In a study conducted by Dahiya et al
10in 2016, post datism and pre-eclampsia were the leading indications for induction of labour.In the present study, post dated pregnancy formed largest group of indication constituting 42% in misoprostol group and 34% in combination group and is in conformation with other studies.
It was observed in the study conducted by Carbone et al11 that maternal complications such as tachysystole was more with only misoprostol group. It was 17.9% in combination group and 19.7% in misoprostol group.In a meta analysis conducted by Chen W., Xue J. et al12 risk of tachysystole with fetal heart rate changes was less with combination group (RR 0.58, 95% CI 0.38 – 0.91; p=0.02).In the present study, tachysystole was observed in 2% of the cases with misoprostol group and none with combination group. 4% of the total cases in misoprostol group and 2% of total cases in combination group had thick meconium stained liquor. 8% of the total cases in misoprostol group and 4% of the total cases in combination group had thin meconium stained liquor.
Conflict of Interest: None
Indian Journal of Public Health Research & Development, April-June 2018, Vol.9, No. 2 99 Source of Support: Self-funding.
ethical Clearance: Taken from Institution Ethics Committee
CONCluSION
Induction of labour is indicated when the benefits to either the mother or the fetus outweigh those of continuing the pregnancy. A risk benefit analysis is necessary before any induction of labour. Combination of Foleys bulb and intravaginal misoprostol is more effective agent for cervical ripening and labour induction than intravaginal misoprostol alone. Both the modes of induction require close observation during course of labour as tachysystole often occur. Babies with meconium stained liquor need expert resuscitation and NICU care. Prior counseling is needed before induction of labour and with regard to the long term outcome of babies admitted to NICU.
Combined method of induction will go long way of its ability to induce labour and its outcome. But one should be cautious of its unpredictable risk.
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