DOI: 10.18410/jebmh/2015/615
ORIGINAL ARTICLE
STUDY OF WHO SAFE ABORTION REGIMEN IN MEDICAL
ABORTIONS IN A TERTIARY CENTRE
Joylene Diana D’Almeida1, Sujaya V. Rao2
HOW TO CITE THIS ARTICLE:
Joylene Diana D’Almeida, Sujaya V. Rao. ”Study of Who Safe Abortion Regimen in Medical Abortions in a
Tertiary Centre”. Journal of Evidence based Medicine and Healthcare; Volume 2, Issue 30, July 27, 2015;
Page: 4344-4350, DOI: 10.18410/jebmh/2015/615
ABSTRACT: Medical abortion is the use of drugs to induce abortion of a fetus. Due to the
advances in the field of research, numerous regimens have been formulated to ensure a fast and
complete expulsion of the fetus. These regimens also aim to towards reduced post abortal side
effects and to decrease the need for surgical evacuation post medical abortion. The objective of
this cross sectional analysis was to study the effectiveness of the WHO safe abortion regimen in a
tertiary care hospital. METHODS: A total of 60 patients with pregnancies of 12 to 30 weeks of
gestation and in whom a medical abortion was deemed necessary were chosen. After instituting
the WHO SAFE ABORTION regimen they were analysed based on indication for pregnancy
termination, onset of pain with WHO regimen and time of expulsion as well as post abortal side
effects and the need for surgical evacuation due to failure of the WHO safe abortion regimen.
Post abortion an ultrasound was done to confirm the success of the regimen. RESULTS: Majority
of patients in our study was multiparous and Mean gestational age for pregnancy termination was
20.6 weeks. The most common indication for medical abortion was incidental diagnosis of fetal
demise or fetal anomaly on ultrasonography (43.6%). The average duration for onset of pain was
3 hours and the average time needed for expulsion was 6 hours from the start of the Abortion
regimen. The most common post abortal side effect was excessive bleeding. Only about 13.3
percent patients needed a surgical evacuation due to failure of the regimen. CONCLUSION: This
study showed that the WHO safe abortion regimen is highly effective and a desirable method for
medical termination of pregnancy, especially in early pregnancy and in patients in whom a
surgical method of abortion could pose as a risk. The WHO SAFE ABORTION regimen has minimal
post abortal side effects, need for surgical intervention and the time needed for expulsion is less.
Hence it can be used as a day care regimen as well. Whenever in doubt of the completeness of
the abortion, a check ultrasound is recommended post procedure to ensure completeness of
expulsion.
KEYWORDS: Safe abortions, Mifepristone, Misoprostol.
INTRODUCTION: Mifepristone is a drug used in the medical termination of pregnancy. It serves
as an alternative to surgical evacuation or vaccum aspiration for abortions.1
Of the variety of drugs available, the combination of mifepristone and mispoprostol is
found to be most effective regimen in inducing abortions. Mifepristone is a progesterone
antagonist and Misoprostol is a prostaglandin PGE1 analogue.2
Mifepristone terminates pregnancy by initiating endometrial erosion that causes the
developing placenta and embryo to detach from the lining of the uterus. Misoprostol, taken after
the Mifepristone, causes dilation of the cervix and increases the frequency and strength of uterine
contractions needed to expel the embryo and pregnancy tissue.3
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ORIGINAL ARTICLE
The number of early medical abortions has increased substantially over the years.
Mifepristone use has grown steadily since its introduction in India and world over in recent years.4
Estimates indicate that mifepristone accounted for roughly 27% of eligible medical abortion
abortions in the United States and is continuing to grow. In India the brand names for
mifepristone are cytotec, oxaprost and cytoprost.
Although misoprostol alone was being traditionally used in medical abortion practices in
had the disadvantage of having excessive G I side effects, causing severe pain and the in
convenience of requiring multiple doses.
Mifepristone and misoprostol regimens have increasingly become an integral part of
medical abortion provision in the country.
Despite these advances, an estimated 22 million abortions continue to be performed
unsafely each year, resulting in the death of an estimated 47,000 women and disabilities for an
additional 5 million women.5Hence the burning need of the hour is a safe and effective medical
method for termination of pregnancies.
The following were the aim and objectives of this crossectional analysis study:
1. To assess the mean gestational age of pregnancies requiring medical abortions.
2. To assess the common indications for medical abortions.
3. To assess the average time for onset of pain and average time required for expulsion with
Who Safe Abortion regimen.
4. To assess the post abortal side effects of WHO SAFE ABORTION regimen.
5. To assess the need for surgical evacuation post failure of medical termination of pregnancy.
MATERIALS AND METHODS: This study was done in the department of Obstetrics and
Gynaecology, Father Muller Medical College hospital, Mangalore. The study was a cross sectional
study.
A total of 60 patients attending the OBG Department at 12 to 30 weeks of pregnancy
requiring a medical abortion were chosen. The patients were of differing parity and ages and
were evaluated based on their symptoms and indication for pregnancy termination. All patients
were instituted with the WHO safe abortion regimen6:
1. Mifepristone low dose 200 mg was given orally followed by misoprostol 800 micrograms per
vaginally after 24 hours.
2. Subsequent misoprostol doses were 400 μg, which was administered vaginally every 3
hours up to four further doses, until expulsion of the products of conception.
3. For pregnancies beyond 24 weeks, the dose of misoprostol should be reduced, due to the
greater sensitivity of the uterus to prostaglandins, but the lack of clinical studies precludes
specific dosing.
The outcome was analysed based on time taken for onset of pain, total time taken for
expulsion, the post abortal side effects like fever, excessive bleeding, chills and rigor as well as G
I side effects and the need for surgical evacuation post failure of medical abortion.
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DOI: 10.18410/jebmh/2015/615
ORIGINAL ARTICLE
INCLUSION CRITERIA:
1. Documented indication for medical abortion such as fetal demise, incomplete abortionor
fetal anomaly
2. Pregnancies between 12 to 30 weeks
EXCLUSION CRITERIA:
1. Allergy to mifepristone or misoprostol.
2. Bronchial asthma.
3. Porphyria.
4. Adrenal failure.
5. Suspected ectopic pregnancy.
6. More than one uterine scar.
7. Long term use of corticosteroids.
RESULTS AND DISCUSSION: When the data was analysed in our study 46.6 percent patients
were found to be primis and 33.3 percent were found to be pregnant for more than two times.
Most patients belonged to the low socio economic status. The average period of gestation of
patients undergoing medical abortion was 20.6 weeks. The distribution of patients in various
stages of pregnancy was as follows:
PERIOD OF GESTATION PERCENTAGE
12 to 16 weeks
20
17 to 21 weeks
26.6
22 to 26 weeks
26.6
27 to 31 weeks
26.6
Table 1
Figure 1
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ORIGINAL ARTICLE
It was noticed that of the total number of patients who underwent medical abortion,
bleeding and decreased fetal movements were seen in 26.6 percent of presenting complaints.
Vast majority of patients (43.3%) who underwent a medical abortion had no presenting
complaints or were incidentally diagnosed with fetal demise or anomalies on Ultrasonography.
Figure 2
Among the indications for medical abortion, 66.6 percent of patients had fetal demise
diagnosed incidentally on routine ultrasound, 6.6 percent had major fetal anomalies like
anencehaly, holoprosencephaly, 6.6 percent has severe symmetrical Growth restriction with
oligohydrmanios and 13.3 percent had severe medical disorders like AML and intractable
hyperemesis.
Figure 3
The average time for the onset of pain once the WHO safe abortion regimen i.e point 0
was instituted was 3 hours. (induction to onset of pain interval)
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The average time taken for expulsion of fetus from the time the WHO safe abortion
regimen i.e., point 0 was instituted was 6 hours, in our study. (Induction to delivery interval)
In a Study of 50 mothers with fetal demise, conducted in a government medical college in
Jammu, 68% patients delivered in 12 hours with the mifepristone and misoprostol combination
regimen and 100% delivered in 24 hours. We obtained comparable results in our study.7
Wagaarachichi et al,8 found that the induction to delivery interval was at an average of 8,
5 hours when the WHO safe abortion regimen was used. 87.5 percent of their patients delivered
in 24 hours.
The documented side effects seen as a result of mifepristone and misoprostol based WHO
safe abortion regimen in the present study were fever (6.6%), chills and rigor (6.6%), abdominal
pain (6.6%) and excessive bleeding (20%)in our study. Over all the study reflected that
occurrence of complications with the WHO safe abortion regimen was low. Hence it proved to be
safe to use in induction of abortion in clinical practice.
At the end of the study it was learnt that only about 13.33 percent of patients required
surgical intervention as a result of failure of medical abortion. Surgical intervention included
dilatation and curettage or suction vaccum aspiration done for EPOC (evacuation of retained
products of conception. Retained products were confirmed by USG post medical abortion.
It was seen that the chances of failure of medical abortion and need for surgical
intervention therefore, increased with advances in period of gestation. Medically induced
abortions usually succeeded and were complete when done in early pregnancy. As pregnancy
advances, the need for surgical methods of abortion becomes evident.
The limitations of our study were that it included pregnancies from 12 weeks on wards
and not earlier gestations. The WHO safe abortion protocol is widely accepted and is efficacious
in early pregnancy.
Each year, 22 million unsafe abortions are estimated to take place. Nearly all unsafe
abortions (98%) occur in developing countries. The total number of unsafe abortions has
increased from about 20 million in 2003 to 22 million in 2008, although the global rate of unsafe
abortion has remained unchanged since 2000. Approximately 47 000 pregnancy-related deaths
are due to complications of unsafe abortion. In addition, 5 million women are estimated to suffer
disability as a result of complications due to unsafe abortion.6
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ORIGINAL ARTICLE
We formed the impression that the WHO safe abortion protocol using mifepristone and
misoprostol is reliable in medical induction of abortions even in pregnancies as advanced as 30
weeks and has reduced number of side effects. The chance of failure and need for surgical
intervention post medical abortion are also low (13.3%) with this regimen.
Contrary to our findings Gary et al,9 feel that increased use of mifepristone/misoprostol for
medical abortion may result in larger numbers of lethal infections from the clostridium sordellii
bacterium. Medical abortion, according to their study, was associated with higher rates of
prolonged bleeding, nausea, vomiting, and pain than is surgical abortion, and the rate of use of
analgesic drugs is greater with medical abortion.
In 2007, in Finland 64%, in Sweden 61%, and in the United Kingdom 35% of all abortions
were performed using the medical method. The continuing increase in the number of medical
abortions performed each year and the risk of major health complications is of great interest to
patients and health care provider.10
CONCLUSION: Mifepristone and misoprostol has increasingly become an integral part of
abortion provision in the country and likely has contributed to a trend towards early abortions.
The WHO safe abortion regimen is highly effective and a desirable method for medical
termination of pregnancy, especially in early pregnancy and in patients in whom a surgical
method of abortion could pose as a risk.
Whenever in doubt of the completeness of the abortion, a check ultrasound is
recommended post procedure to ensure completeness of expulsion
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ORIGINAL ARTICLE
8. Wagaarachi PT et. al. Medical management of late intrauterine death using a combination of
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http://www.ncbi.nlm.nih.gov/pubmed/19888037. PMID: 19888037.
AUTHORS:
1. Joylene Diana D’Almeida
2. Sujaya V. Rao
PARTICULARS OF CONTRIBUTORS:
1. Assistant Professor & Consultant
Gynecologist, Department of Obstetrics
& Gynecology, Father Muller Medical
College, Hospital.
2. Professor & Head of Unit, Department
of Obstetrics & Gynecology, Father
Muller Medical College, Hospital.
NAME ADDRESS EMAIL ID OF THE
CORRESPONDING AUTHOR:
Dr. Joylene Diana D’Almeida,
Dal Villa,
Jeppu Bappal 1st Cross,
Mangalore-02.
E-mail: joylene16@yahoo.com
Date
Date
Date
Date
of
of
of
of
Submission: 07/07/2015.
Peer Review: 10/07/2015.
Acceptance: 17/07/2015.
Publishing: 24/07/2015.
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