COMPARATIVE STUDY BETWEEN COMBINED USE OF INTRACERVICAL FOLEY CATHETER WITH VAGINAL MISOPROSTOL VERSUS VAGINAL MISOPROSTOL FOR MID TRIMESTER ABORTIONS IN PATIENTS WITH PREVIOUS CAESAREAN SECTIONS

Total dose of misoprostol required in combined was (682.33+_ 245) micrograms and in with < No significant difference as regard occurrence of advere effects between the two groups. Conclusions: Combined use of intracervical foley catheter and vaginal misoprostol is a novel safe, effective and acceptable method for termination of second trimester in patients with previous caesarean sectionpregnancy.


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Total dose of misoprostol required in combined group was (682.33+_ 245) micrograms and (1100 +_ 212) micrograms in misoprost group with p value < 0.001 No significant difference as regard occurrence of advere effects between the two groups. Conclusions:Combined use of intracervical foley catheter and vaginal misoprostol is a novel safe, effective and acceptable method for termination of second trimester in patients with previous caesarean sectionpregnancy.

…………………………………………………………………………………………………….... Introduction:-
Abortion is defined as 'termination of pregnancy by any means before the fetus is viable'. Viability is now considered to be reached at 23-24 weeks of gestation, in India it is 28 weeks. Second trimester, or mid-trimester, is a period ranging from 13 to 28 weeks of gestation, which again is subdivided into an early period between 13 and 20 weeks and a late period between 20 and 28 weeks. In this review, we are limited to abortions up to 20 weeks gestation.
Worldwide mid-trimester abortion constitutes 10-15% of all induced abortions but is responsible for two-thirds of all major complications . With delay in the marriages leading to increased risk of aneuploidy and further advancements in medical science in the form of prenatal screening for fetal anomalies , mid trimester abortion is increasing day by day.
With the increasing trends of caesarean section, obstetricians now commonly face the problem to tackle termination of pregnancy in scarred uterus. This challenge further increases if it is mid trimester abortion with previous caesarean section.
Many studies are still undergoing so as to decide the safest method of mid trimester abortion in patients with previous caesarean sections.
Misoprostol is a synthetic prostaglandin E1 analogue. Originally used to inhibit peptic ulcer. It was first used in obstetrics to induce abortion in 1988 . Now it is widely used for induction of labour, termination of pregnancy and management of postpartum haemorrhage but still its use in obstetrics is not approved by FDA.
The Foley's catheter traction is the cheapest, safest and successful mechanical method of cervical dilatation according to various studies. Transcervical extraamniotic intracervical foleys insertion causes mechanical stretching of the cervix and release of endogenous prostaglandins This study aims to compare the safety and efficacy of two regimens in mid trimester abortion in patients with previous caesarean section either by using combination of intracervical foleys with vaginal misoprostand vaginal misoprost alone.

Methods:-
This was a prospective randomized controlled trial conducted during the period of January 2019 to January 2020 in the department of obstetrics and gynaecology in patna medical college and hospital, Patna. The study recruited 108patients , who were randomly allocated groups. Misoprost administration was repeated at 6 hours interval. As soon as the catheter was expelled reassessment of the dilatation of the cervix was done.
In group B patients, with aseptic precautions 200μg misoprostol tablet was inserted in the posterior fornix every 6 hours till the expulsion or till maximum of six tablets were given.
The failure of the therapy was considered if there was no expulsion after 48 hours or there were serious side effects needing the treatment to be stopped.

Statistic Alanalysis
Pearson chi square&fischer's exact test were used to compare the categorical data between the two groups while Mann Whitney U test was used to compare the continuous data. P value < 0.05 is applied as statistically significant.   Induction to abortion interval was 24.16+_ 1.52 hours in group A whereas it was 45.76+_1.63 hours in group B (p value <0.021) showing that combined use of intracervical foley's with misoprostol is associated with shorter expulsion time and also resulting to shorter hospital stay in combined group with respect to group B.
TABLE4shows complications due to intervention in both the groups like nausea & vomiting, headache & giddiness, excessive bleeding, fever, need for surgical intervention , it was found that complications noted in both the groups were statistically not significant. There was no rupture of uterus in any group. 1 case in group A and 3 cases in group B required surgical intervention for complete evacuation of uterus.

Discussion:-
With the increasing global trend in caesarean section and limited evidence available on safe second term pregnancy termination in these women. Therefore, the decision to attempt pregnancy termination in the second trimester in 638 cases with previous uterine scar should be made on a case-by case basis, after consideration of the number of previous cesarean sections and gestational age, and availability of facilites to tackle emergency. In our study the overall dose of misoprostol required in combination with intracervical foley's catheter was significantally reduced in comparison to the doses required in case of misoprostol alone. Induction to abortion interval was also reduced in combined group in comparison to misoprostol alone group.
The most efficacious regimen for medical termination of second trimester pregnancy appears to be use of mifepristone followed by misoprostol. This regimen has an abortion rate of 97-99% in first 24 hours. In low resource setting mifepristone is non affordable or non available. Misoprostol is widely used for second trimester termination of pregnancy. However there is still a debate about the best route and dose with minimum induction to delivery interval and minimum side effects . In order to shorten the induction to delivery interval and to minimize the side effects of repeated dose of misoprostol, intracervical Foley's catheter combination is one of the better options. The purpose of our study was to compare the efficacy and outcome of misoprostol alone and in combination with intracervical Foley's catheter for medical termination of second trimester pregnancy. In this study the induction to deliveryinterval (IDI) was 24.16 +_1.52 hours in combined group which is significantly shorter than misoprostol alone group (45.76+-1.63 hours) .The side effects and complication was comparable without any significant difference. No uterine rupture observed in our study.The induction to delivery interval of misoprostol alone showed marked variation among various studies. It varies from 9 -47 hours, with success rate of 60-100%. Similar induction to delivery interval was observed by Shabana 28. These large variations in the outcome may be due to difference in the regimens used, routes of administration, indication, parity and the gestational age at the time of presentation. A study by Toptas et al., was conducted in a total of 91 pregnancies. Women between 13 to 26 gestational weeks were included in the study. Study participants received intravaginal misoprostol in combination with Foley's catheter (n=46) or intravaginal misoprostol alone (n=45). The authors concluded that combination of intravaginal misoprostol and extra amniotic Foley catheter for second trimester pregnancy termination does not provide additional efficacy with one case experiencing uterine rupture in the catheter group. Recently Razk et al., conducted comparative study including 90 pregnant women between 13 and 24 gestational weeks. Enrolled women were equally allocated into three groups. The first received vaginal misoprostol (n=30), the second received intracervical Foley catheter alone (n=30) and the third received both (n=30)30. The induction to abortion interval was 7.5±1.25 h in the combined group, compared to 11.76± 1.63 h in the misoprostol group and 19.76±1.52 h in the catheter alone group .

Conclusion:-
Intracervical foley's catheter with Misoprostol is safe and more efficacious than misoprostol alone for second trimester pregnancy termination in women with previous cesarean sectionwith no significant increase in side effects.