Title: Comparative study of Mifepristone with Vaginal Misoprostol and Vaginal Misoprostol alone for second trimester medical termination of pregnancy
Abstract: INTRODUCTION:
Abortion is defined as the termination of pregnancy after implantation of the blastocyst in the endometrium but before fetus has attained the period of viability, before 20 weeks of gestation or weight less than 500 grams.(WHO). Abortions can be classified as either Spontaneous or Induced. About 85% of the induced abortions are in the first trimester and 15% in the second trimester. Ideally if the first trimester termination is done, prognosis is better. Morbidity and mortality rates in second trimester are 3-4 times higher than that of the first trimester terminating. There are various reasons for delay in seeking abortion:
1. Lack of information on the availability of abortion facilities.
2. Ignorance and / or psychological denial of pregnancy.
3. Ambivalence regarding the desirability of abortion
4. Late identification of Medical disorders contraindicating the continuation of pregnancy.
5. Late discovery of fetal malformation.
6. Lack of financial resources to reach the hospitals.
Induction of medical abortion in India is a hallmark in women's health. Medical abortion is an approach to pregnancy termination which is non invasive with minimal side effects. The mortality and morbidity rates are higher in second trimester termination of pregnancy than in first trimester termination of pregnancy. There is a search for better, safer, quickest, costeffective, convenient and feasible method for termination in second trimester. So in this study, medical method of termination of second trimester pregnancy with mifepristone and misoprostol is compared with misoprostol alone.
AIM OF THE STUDY:
1. To compare the outcome of tablet mifepristone and vaginal misoprostol versus vaginal misoprostol alone for second trimester medical termination of pregnancy.
2. To evaluate induction abortion interval.
3. To study and evaluate failure rate, complications, and side effects.
MATERIAL AND METHODS:
Inclusion criteria:
1. Pregnant women who need MTP from 13 — 20 weeks in family planning OPD.
2. Pregnant women with anomalous baby from 13-20 weeks of gestation.
3. Pregnant women with obstetric & medical indications for 2nd trimester termination from 13-20 weeks.
The study to be conducted in women admitted in GRH for second trimester termination of pregnancy. They were grouped into two GROUP A-mifepristone &misoprostol GROUPB-misoprostol alone Group A : T. mifepristone 200mg orally given . 48 hrs later, under strict aseptic precaution , misoprostol 400p.g is kept in the posterior fornix. The dose is repeated after 8hrs, 6hours, 4hours,4hours to the maximum of 5 doses. Group B : Under strict aseptic precaution 400iug misoprostol is kept in the posterior fomix. The dose is repeated after 8 hrs, 6 hours, 4 hours, 4 hours to the maximum of 5 doses. Analgesics and antibiotics are given. In each groups the following parameters and noted.
➢ The time of application of tablets.
➢ Number of doses of misoprostol.
➢ Monitoring of pulse, blood pressure, temperature.
➢ Progression of abortion assessed.
➢ oxytocin augmentation is done with oxytocin 10 units in 500m1 of normalsaline at 10 to 20 drops/minute is done when the cervix is effaced and 2-3 cm dilated with poor progression of abortion.
➢ Side effects like rigor, fever, nausea, vomiting, headache, abdominal pain, diarrhea, dizziness. ➢ Complications like retained products, bleeding, rupture, infection noted.
➢ Interval between induction and abortion interval noted.
➢ Whether the placenta expelled into noted. Inj. Oxytocin 10 units in 500m1 of normal saline at 20-30 drops per minute started if the placenta did not expelled in 30-60minutes.
➢ The placenta is examined for its completeness. routine check curettage is not done. It is done only when there is suspicion of retained products.
➢ After expulsion the women is kept in the labour ward for two hours to monitor vitals and bleeding.
➢ Inj. Anti D is given for Rh negative mothers.
➢ Milk suppression is given with cabergoline in women who undergo MTP more than 15 weeks.
➢ USG is done to rule out retained products after 24 hours. if there is significant retained products check curettage done.
➢ Repeat hemoglobin is done after 48 hours.
➢ Advise regarding contraception given. Patient is followed at the end of one month and the end of three months to enquire about menstrual regularity and general status.
RESULTS:
42% of patients are between 25-30 years of age in mifepristone and misoprostol group and 52% in misoprostol group.
➢ 56% are multigravida in mifepristone and misoprostol group and 62% in misoprostol group.
➢ Mean gestational age is 16.54 weeks mifepristone and misoprostol group and 16.20 weeks in misoprostol group.
➢ There is no statistically significant difference in age, parity, and gestational age in weeks between mifepristone with misoprostol group and misoprostol group.
➢ Induction to abortion interval is (12.93hrs.) shorter in mifepristone and misoprostol group than( 19.18 hrs.) in misoprostol group and is statistically significant. (p=0.001).
➢ The number of doses of misoprostol needed in mifepristone with misoprostol is less than misoprostol alone group and is statistically significant (p=0.008).
➢ Requirement of oxytocin augmentation was much less in mifepristone and misoprostol group (4%) than misoprostol group (10%) but not statistically significant. (p=0.481).
➢ The success rate is 98% in mifepristone with misoprostol group than 90% in misoprostol group, and is statistically significant. (p=0.027).
➢ Complete abortion occurred in 90% in mifepristone &misoprostol group and 60% misoprostol group. ➢ There is no statistically significance of age in relation to induction outcome in both the groups. (p=0.282).
➢ There is no statistically significance of parity in relation to induction outcome in both the groups. (p=0.662)
➢ There is no statistically significance of gestational age and relation to induction outcome in both the groups. (p =0.380).
➢ Side effects & Complications occurred in less number of patients 18% in mifepristone with misoprostol group than misoprostol group 52% and is statistically significant. (p=0.012).
➢ Incomplete abortion requiring curettage is more with misoprostol group (15/50) 30% than mifepristone with misoprostol group (4/50) 8% and is statistically significant(p=0.038).
CONCLUSION:
The combination of mifepristone and misoprostol is now an established and highly effective, safe method for second trimester medical termination of pregnancy. The combination of mifepristone and misoprostol significantly reduces the induction abortion interval. Mifepristone followed by misoprostol reduces the number of doses of misoprostol and hence the incidence of side effects and complications are reduced. Where mifepristone is not available or affordable, misoprostol alone has also been used and is shown to be effective, although higher total dosage is needed and the efficacy is lower than for the combined regimen. Therefore, whenever possible, combined regimen should be used. Future studies should focus on improving the pain management, treatment of women with failed medical abortion after 24 hrs and the safety of medical abortions regimens in women with a previous caesarean section or uterine scar.
Publication Year: 2017
Publication Date: 2017-04-01
Language: en
Type: dissertation
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