Medical termination of pregnancy by mifepristone
and sublingual misoprostol: preliminary results of
their use in reproductive health centre of Nabeul
Halleb, D1; Temimi, F2; Belcaid, A1; Ben Khedija,
W1; Wahbi, H1
1 Centre de la Sante´ de la Reproduction, Nabeul, Tunisia; 2 Ofﬁce
National de la Famille et de la Population, Tunis, Tunisia
Introduction: Medical termination of pregnancy (TOP) is a
method increasingly used worldwide. It was introduced in Tunisia
by the National Ofﬁce of Family and Population, since 1994 as
part of research. Then it was extended in 22 of the 24
reproductive health centres. Medical TOP was introduced in the
Nabeul Centre since November 2002. We used three different
protocols; the third protocol was introduced since March 2010.
The aim of the study was to describe the effects of this protocol
on medical TOP effectiveness; frequency of side effects, and
frequency of TOP failure.
Methods: We conducted a retrospective observational study
performed in the reproductive health centre of Nabeul from April
2010 to June 2010 about women who chose medical TOP.
For all women consulting for TOP, the medical staff explained
the interest of medical TOP and the risks of this method
compared to the surgical one.
On the ﬁrst day, counselling was conducted, clinical and
ultrasound examinations were made to identify no exclusion
factors: anaemia, ectopic pregnancy, and pregnancy off the pill,
kidney failure and liver failure. Then 200 mg of mifepristone was
administered by the midwife or the physician.
On the second day, 400 lg of misoprostol was administered by
the sublingual route. On the ﬁfteenth day, a check was performed
by a clinical and ultrasound examination.
We considered as method failure: surgical aspiration for
ongoing pregnancy, a total retention or signiﬁcant bleeding.
Withdrawals were not recorded as such.
The study analysis was performed by SPSS with statistical
veriﬁcation by the v2 and ANOVA at a signiﬁcance level of 5%
(P £ 0.05).
Results: We included 562 women (27.48% single and 72.52%
married) who have chosen medical TOP during the study period.
The average age was 32 years, ranging from 18 to 50. Educational
level was illiterate for 5.1%, elementary or secondary for 78.8%
and university for 16%. In 77% of cases women had not had a
medical TOP before, 16.5% of them had one previously, 4.7%
twice and 1.9% three or more times. The age of pregnancy was in
60% of cases <6 weeks of gestation, in 34.7% of cases between 6
and 7 weeks of gestation, and in 6.9% of cases between 8 and
9 weeks. The expulsion occurred in 54.2% of cases before 4 hours
and in 44.4% after 4 hours. Pain was reported in 10.5% of cases
and need appropriate treatment. Surgical abortion was used in
1.2% (ongoing pregnancy in 1% of cases and bleeding 0.2% of
Statistical analysis showed: (i) a signiﬁcant relationship between
gestational age and the period of expulsion (P = 0.047); no
signiﬁcant relationship between the gestational age and the failure
of the TOP; no signiﬁcant relationship between educational level
and gestational age at the time of ﬁrst consultation (P = 0.243).
Conclusion: The protocol adopted in this study appeared to be
safe, effective and acceptable to women. However we must be
aware and explain to women that the use of medical TOP does
not replace contraception, contrary to popular belief.