|Year : 2017 | Volume
| Issue : 1 | Page : 35-38
Study on effectiveness and outcome of mifepristone and misoprostol in medical termination of pregnancy
Ajay K Jawarkar1, Pushpa O Lokare1, Anuradha Kizhatil1, Jyoti Ajay Jawarkar2, Sandhya G Kale3
1 Department of Community Medicine, Dr. Panjabrao Deshmukh Memorial Medical College, Amravati, Maharashtra, India
2 Department of OBGY, Jawarkar Hospital, Amravati, Maharashtra, India
3 Department of OBGY, Kale Hospital, Amravati, Maharashtra, India
|Date of Web Publication||15-Feb-2017|
Pushpa O Lokare
Department of Community Medicine, Dr. Panjabrao Deshmukh Memorial Medical College, Amravati - 444 603, Maharashtra
Source of Support: None, Conflict of Interest: None
BACKGROUND: One of the most effective and safest medical abortion (MA) regimens consist of the use of a combination of mifepristone and misoprostol. Misoprostol can be administrated by oral or vaginal route after giving a single dose of mifepristone. The present study was conducted to assess the effectiveness and complications by these two routes.
SUBJECTS AND METHODS: The present study was nonrandomized clinical trial conducted at two private hospitals and medical college, Amravati city. The women having a history of amenorrhea ≤49 days and who were willing for medical termination of pregnancy by MA pills method were included in the study during the 1-year after obtaining ethical approval. The women in both groups were given tablet mifepristone (200 mg day) on day 1 orally followed by tablet misoprostol (two tablets of 200 μg) on day 3 orally in one group and vaginally in other group.
RESULTS: The success rate of medical termination in group with oral administration of misoprostol was 96.3% as compared to 97.7% success rate in group with vaginal administration of misoprostol. The gastrointestinal side effects were 41.4% in group with oral administration of misoprostol as compared to 21.7% in group with vaginal administration of misoprostol. The Chi-square test of significance was applied using SPSS software version 16.0.
CONCLUSIONS: The success of medical termination of pregnancy was comparable in both groups with slightly higher success rate by vaginal route of administration of misoprostol.
Keywords: Medical termination of pregnancy, mifepristone, misoprostol
|How to cite this article:|
Jawarkar AK, Lokare PO, Kizhatil A, Jawarkar JA, Kale SG. Study on effectiveness and outcome of mifepristone and misoprostol in medical termination of pregnancy. Int J Health Allied Sci 2017;6:35-8
|How to cite this URL:|
Jawarkar AK, Lokare PO, Kizhatil A, Jawarkar JA, Kale SG. Study on effectiveness and outcome of mifepristone and misoprostol in medical termination of pregnancy. Int J Health Allied Sci [serial online] 2017 [cited 2022 Jan 23];6:35-8. Available from: https://www.ijhas.in/text.asp?2017/6/1/35/200200
Globally, it is estimated that out of the 210 million pregnancies that occur each year, 80 million are unintended. The proportion of all abortions that are unsafe has increased from 44% in 1995 and 47% in 2003 to 49% in 2008. The unsafe abortion leads to risk of morbidity and mortality mainly due to severe infections and bleeding resulting from the unsafe procedure or due to organ damage. The contraceptive use has resulted in reducing the number of unintended pregnancies but has not eliminated the need for access to safe abortion. The availability of facilities and trained service providers within reach of the entire population is essential for ensuring access to safe abortion services. Almost all countries have provisions under which abortion is legal, including to save the woman's life, to preserve physical or mental health, when the pregnancy is a result of rape or incest, or on socioeconomic grounds. Where abortion is legal, challenges may arise in terms of health-system restrictions on where the services can be provided, procurement of the drugs, and provided training to properly inform and counsel patients about their options.
The methods available for medical termination in early pregnancy are vaccum aspiration and medial methods. Medical abortion (MA) in India is approved up to 7 weeks of amenorrhea (49 days from the 1st day of the last menstrual period in women with the regular cycle of 28 days). MA is simple and a safe, nonsurgical procedure in which drugs are used to induce abortion. The most effective and safest MA regimen consists of a combination of mifepristone and misoprostol. Mifepristone was approved on September 28, 2000, by the Food and Drug Administration for the termination of early pregnancy. In India, the use of mifepristone (RU-486,) was approved by Drug Controller of India in April 2002. Mifepristone blocks the action of progesterone to enhance the contractility of the uterus and prompt the detachment of the implanted embryo. Misoprostol was licensed for use in India in 2002. It is a synthetic prostaglandin E1 analog. It binds to myometrial cells causing strong uterine contractions, cervical softening and dilation. This leads to expulsion of conceptus from the uterus. The efficacy of misoprostol may vary depending upon gestational age, the route of administration, or the frequency of dosing. Mifepristone should always be administered orally. The recommended dose is 200 mg. Administration of misoprostol is recommended 1–2 days (24–48 h) following ingestion of mifepristone. For vaginal, buccal or sublingual routes, the recommended dose of misoprostol is 800 µg. For oral administration, the recommended dose of misoprostol is 400 µg. MA options have made abortion more available to women in a variety of health-care settings, and home administration of MA is also highly acceptable.
The common side effects reported with this regime of MA pills include pain, bleeding, nausea, vomiting, fever with chills, diarrhea, headache, feeling of warmth, dizziness, and fatigue. A large number of studies are available using mifepristone followed by misoprostol which results in abortion in more than 90% of women with pregnancies up to 7 weeks of gestation. Various studies have conducted on the effectiveness of MA, very few studies are conducted to know the effectiveness of oral administration of mifepristone followed by oral versus vaginal administration of misoprostol. The present study is intended to know the effectiveness and complications by oral versus vaginal route administration of misoprostol.
| Subjects and Methods|| |
The present nonrandomized clinical trial was conducted at Dr. Panjabrao Deshmukh Medical College, Amravati, and two private nursing hospitals in Amravati city of Maharashtra. The clinical trial was registered with Indian Council of Medical Research clinical trial registry (CTRI/2014/07/004771). The women having a history of amenorrhea ≤49 days and who were willing for medical termination of pregnancy by MA pills method were included in the study. The pregnancy was confirmed by urine pregnancy test as well as ultrasonography. The written informed consent was obtained from all the participants. The study was carried out from January 2014 to December 2014 for 1 year. The women with ectopic pregnancies, history of bronchial asthma, hepatic insufficiency, chronic failure of the adrenal glands, clotting factor deficiencies, current long-term therapy with corticosteroids, drug allergy and those not willing to participate were excluded from the study.
Two types of drug were used in the study, i.e., mifepristone along with misoprostol which are the recommend drug for MA. The present study consisted of two groups in which method of drug administration was different. The women in one group (Group A) were given one tablet mifepristone (200 mg day) on day 1 for oral administration followed by tablets of misoprostol (two tablets of 200 µg) on day 3 for oral administration. The women in the second group (Group B) were given one tablet mifepristone (200 mg day) on day 1 orally followed by tablets of misoprostol (two tablets of 200 µg) on day 3 for vaginal administration.
The sociodemographic information and obstetric history was collected from the participants. The predesigned questionnaire for collecting the data on method of drug administration, health status of women during follow-up at regular intervals and complications if any was used. The follow-up was planned up to 15 days from every 2nd day up to 6 days thereafter on the 10th day and 15th of drug administration. Those women who could not come for follow-up were contacted by telephone for obtaining required information and insisted for hospital visit. Thus, a maximum attempt was done to minimize lost to follow-up. The complete removal of the product of conceptus was assessed by ultrasonography during follow-up. Women having failure with MA method were immediately shifted to surgical abortion methods after completion of stipulated action period.
Ethical approval was taken from Institutional Ethical Committee before initiation of the study.
The statistical analysis was done by calculating proportions and applying Chi-square test of significance and Fischer exact test at 0.05 level of significance. The software used was SPSS version 16.0.
Definitions used in the study
- Failure with MA is a term used when a surgical curettage is performed for any reason including clinician's decision, patient's choice, complications or a true drug failure or incomplete expulsion of products of conception 
- True drug failure is defined as the presence of gestational cardiac activity 2 weeks following mifepristone and misoprostol administration. It occurs in <1% of women and pregnancy should be terminated by surgical evacuation 
- Excessive bleeding was defined as soaking through two thick full-size sanitary pads per hour for 2 consecutive hours.
| Results|| |
In the present study, effect of medical termination by two methods was compared. In Group A, total women 134 were included where misoprostol was administrated by oral route on the 3rd day. In Group B, there were total 129 women and were given misoprostol by vaginal route on day 3.
In the present study, out of total 134 women in Group A (oral administration), 61.2% were below 30 years of age while out of 129 women in Group B 74.4% were in the same age group. All women were belonging to Hindu religion in Group A as compared to 86.8% were Hindu in Group B. The proportion of women having educational status below high school was 66.4% in Group A while it was 58.1% in Group B. The proportion of married women in both groups was higher, i.e., 89.5% and 96.9%, respectively. Similarly, the proportion of homemakers was 80.6% in Group A and 86% in Group B [Table 1]. The mean gestational age of women in both groups was 6 weeks.
As shown in Graph 1, the success rate of medical termination in Group A was 96.3% as compared to 97.7% success rate in Group B. In Group A, out of total five failures of medical termination of pregnancy, all are shifted toward surgical evacuation except one woman who refused for surgical evacuation and continued her pregnancy. In Group B, all three women having a failure of MA were undergone surgical evacuation.
It was found that in Group A, the success of medical termination of pregnancy was 96.8% among those women with gravid status ≤2 while it was 95.9% in the women with gravid status >2. Thus, gravid status was not significantly associated with the success of medical termination in Group A (P = 0.58). In Group B, the success of medical termination of pregnancy was higher (100%) in the women with gravid status >2. However, the difference was not statistically significant (P = 0.17) [Table 2].
|Table 2: Distribution of success of medical termination with gravid status in both group|
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[Table 3] revealed the complications of medical termination of pregnancy in two groups. In Group A, nausea and vomiting was present among 41.4% of the women as compared to 21.7% in Group B. The observed difference was statistically significant (P < 0.01). The bleeding with abdominal pain for longer duration was present in women from Group A (2.2%) of which two women required blood transfusion because of excessive per vaginal bleeding. The bleeding with abdominal pain was present only in a single woman in Group B. The proportion of women with retained product of conception was higher (3.7%) in Group A as compared to Group B (2.3%).
|Table 3: Complications of medical termination of pregnancy in two groups|
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| Discussion|| |
Recently, the use of mifepristone and misoprostol for medical termination has gained wide acceptance by women and medical practitioners. There are two methods of administration of misoprostol either by oral or by vaginal route after giving single dose mifepristone. For knowing the effectiveness and complications of medical termination by two route present study was planned. It was found that failure after mifepristone with vaginal route was 2.3%. This finding was consistent with a study where they found that the frequency of failure after MA, followed by subsequent surgical intervention, is 2%–6% in cases of mifepristone with vaginal prostaglandin analog. In a study by D'Almeida and Rao, 13.3% patients needed a surgical evacuation due to the failure of the regimen by this route which was higher as compared to the present study.
The success rate of medical termination by oral route was 96.3% as compared to 97.7% success rate in group with vaginal route. el-Refaey et al. who found that 87% of patients receiving oral misoprostol aborted, while vaginal administration of misoprostol resulted in a 95% abortion rate. Thus, vaginal route of administration resulted in higher success rate.
Odeh et al. in their study revealed that women who had more than one pregnancy required uterine evacuation more likely than primigravid women. Our study had not shown any association with gravid status with success or failure of medical termination of pregnancy by any route.
The documented side effects seen as a result of mifepristone and misoprostol based safe abortion regimen in a study were fever (6.6%), chills and rigor (6.6%), abdominal pain (6.6%) and excessive bleeding (20%) after vaginal route of administration. The majority of the patient were prescribed analgesics and antispasmodics in case of any pain or fever in the present study. That might be the reasons for minimal complications in our study. World Health Organization (WHO) stated that complications like gastrointestinal upset are more common with oral route than vaginal route. The results of our study are similar to the findings documented by WHO.
All women, in our study, were about 6 weeks of gestational age. The study needs to be conducted for comparing the effect of medical termination in different gestational age. However, in India, Medical Termination of Pregnancy pills are permitted up to 49 days of pregnancy.
| Conclusion|| |
The success of medical termination of pregnancy was comparable in both groups with slightly higher success rate by vaginal route of administration of misoprostol with lesser complications. The gravid status had not shown any association with success rate of medical termination in any of the methods. The complications like nausea and vomiting were significantly higher in group with oral administration of misoprostol. Although the complications like bleeding with abdominal pain and retained product of conception was slightly higher in group with oral administration of misoprostol as compared to vaginal administration was not statistically significant.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]