|
Middle East Fertility Society Journal
Middle East Fertility Society
ISSN: 1110-5690
Vol. 12, Num. 1, 2007, pp. 53-56
|
Oral vs Rectal Route of Misoprostol Administration : A randomized
Controlled Trial
Middle East Fertility Society Journal, Vol. 12, No. 1, 2007, pp. 53-56
Oral versus rectal route of misoprostol administration:
a randomized controlled trial
Farid Ibrahim Hassan, M.D.,Mohamed Khalid Mostapha, M.D., Mahmoud Abdel Sattar, M.D., Emad Marouf, M.D., Shokry Abdel Azim, M.D.
Department of Obstetrics and Gynecology, Al-Hussein
Hospital, Al-Azhar University, Cairo, Egypt
Correspondence:Dr. Farid I. Hassan, Department of Ob. and Gyn., Al-Hussein Hospital, Al-Azhar university, Cairo, Egypt
Received on June 3, 2006; revised and accepted on October 12, 2006
Code Number: mf07009
ABSTRACT
Objective: to compare between the efficacy of oral
versus rectal misoprostol in the treatment of incomplete abortion.
Design: prospective controlled trial. Patients
were allocated to intervention using alternate sequence
Setting: Al-Hussein Hospital, Al-Azhar University
Materials and methods: one hundred women with retained products
of conception were divided into two groups: G1: fifty women received
misoprostol 200 µg misoprostol/4 hs rectally and G2; fifty women received it
orally. Follow up and side effects were recorded
Results: There was no significant difference
between both groups regarding their background characteristics, response to
misoprostol, need to do D&C or side effects. the dose of 200ug misoprostol
every 4 hours (orally and rectally) for a maximum of 3 doses was not only
effective in complete evacuation but also had low incidence of side-effects
especially vomiting diarrhea and bleeding
Conclusion: misoprostol whether by oral or rectal
route seems to be an effective as a non invasive method for evacuation of the
uterus in women with retained products of conception.
Keywords: Misoprostol, incomplete abortion
Misoprostol is a
synthetic prostaglandin El analogue, which is cheap effective and
does not require special storage conditions, these features may be beneficial
in regions with limited resource for health care. (1).
Spontaneous abortion is
a common obstetric problem, occurring approximately in 14 19% of all clinically
recognized pregnancies (2). The use of misoprostol in women with retained
products of conception reduces the potential risks that may be associated with
general anesthesia and surgical evacuation (3, 4).
It
is still unclear to determine the optimal dose and route of administration of
misoprostol that can give the highest complete abortion rate and least side
effects (5). Misoprostol is offered in our hospital via the oral route, based
on published trials demonstrating the efficacy and simplicity of this method
(6, 7). The purpose of this study was to compare between the efficacies of oral
versus rectal misoprostol in the treatment of incomplete abortion.
MATERIALS AND METHODS
One hundred pregnant
women were recruited from Obstetrics and Gynecology department, Al-Hussein University Hospital. All women had first
Table 1. Comparison between patients
Characteristics in rectal group and oral group
|
Oral
|
Rectal
|
P value
|
Significance
|
|
|
|
|
|
Maternal age (Y)
|
24.8 ± 5.5
|
25.4 ± 5.7
|
0.341
|
N.S
|
Weight (Kg)
|
66.9 ± 12.2
|
66.9 ± 12.5
|
0.701
|
N.S
|
Parity
|
3.9 ± 2.2
|
3.7 ± 2.1
|
0.451
|
N.S
|
Gestational age (wks)
|
8.5 ± 1.7
|
7.5 ± 0.6
|
0.617
|
N.S
|
The initial uterine size (preg.wks)
|
7.6 ± 0.5
|
8.2 ± 1.5
|
0.423
|
N.S
|
trimester incomplete abortion diagnosed
clinically by history, examination, positive pregnancy test, and trans-vaginal
sonar showing retained products of conceptions.
Women were divided into
two groups: The 1st group (I): included 50 patients treated with 200 ug
misoprostol/4 hs rectally. The 2nd group (II): included 50 women treated with
200 ug/4 hs orally. Allocation to either group was done based on alternate
sequence.
The misoprostol-treated
groups were selected according to the following criteria: Hemodynamically
stable (pulse <100 bpm, Bl.p >90/60 mmHg, No history of bronchial asthma,
No known allergy to PGs, mild vaginal bleeding).
An informed consent was obtained from al cases. During treatment all patients were observed
carefully for Amount of blood loss by the number of vaginal napkin used and Hb%
for all patients before treatment.
After 24
hours of misoprostol intake proper examination was done to all cases to evaluate
the result of misoprostol use. if there is no vaginal bleeding, and uterus is
empty by trans-vaginal U/S the patient then discharged and followed-up after
one week.
Drug-related data were
recorded as follows: Number of misoprostol tablets used till complete
evacuation has occurred; Duration of time till complete evacuation has occurred
and Side-effects of misoprostol.
All data were analyzed
statistically using Chi-square test to determine if statistically significant
difference is present between the patients and the incidence of complications.
Mann-Whitney U test was used to determine whether there was any statistically
significant difference in parity and gravidity between the groups. The level of
significance was <0.05.
RESULTS
There was no statistically
significant difference in the background characteristics between the two groups
(Table 1). In rectal group, complete evacuation with no need for D & C
occurred in 33 patients (66%) and 17 patients (34%) failed and D & C was
done to evacuate the contents completely. The failed cases were due to: Two
cases showed an attack of severe vaginal bleeding after about 1-3 hours
misoprostol intake.
Table 2. Factors affecting misoprostol response in
rectal and oral groups
|
Rectal group
|
Oral group
|
|
|
|
|
|
|
Failed cases with
incomplete evacuation
|
Succeeded cases with
complete evacuation
|
Failed cases with
incomplete evacuation
|
Succeeded cases with
complete evacuation
|
|
|
|
|
|
Maternal age (Y)
|
24.5 ± 5.4
|
24.3 ± 5.5
|
24.7 ± 5.2
|
24.4 ± 5.3
|
Weight (Kg)
|
66.5 ± 12.1
|
66.4 ± 12.2
|
66.3 ± 12.2
|
66.4 ± 12.1
|
Parity
|
3.8 ± 2.1
|
3.7 ± 1.9
|
3.7 ± 2.3
|
3.6 ± 2.2
|
Gestational age (wks)
|
9.5 ± 2.1
|
7.1 ± 1.6*
|
9.7 ± 2.4
|
7.1 ± 1.8*
|
Uterine size (preg.wks)
|
9.4 ± 1.8
|
7.2 ± 0.6*
|
9.6 ± 1.7
|
7.2 ± 0.7*
|
Table 3. Comparison between the
rate of complications in rectal group and oral group.
Complication
|
rectal
No = 50
|
oral
No = 50
|
P-value
|
Sign
|
|
|
|
|
|
Nausea
|
24 (48%)
|
28(56%)
|
0.300
|
N.S
|
Vomiting
|
7 (14%)
|
9 (18%)
|
0.585
|
N.S
|
Diarrhea
|
3 (6%)
|
4 (8%)
|
0.695
|
N.S
|
Breast Tenderness
|
7 (14%)
|
6 (12%)
|
0.766
|
N.S
|
Abdominal Colic
|
43 (86%)
|
42 (84%)
|
0.779
|
N.S
|
Fatigue
|
9 (18%)
|
11 (22%)
|
0.617
|
N.S
|
Headache
|
10 (20%)
|
12 (24%)
|
0.629
|
N.S
|
Sever bleeding
|
2 (4%)
|
3 (6%)
|
0.674
|
N.S
|
This bleeding caused marked hypotension, so an
urgent D & C was done to stop the bleeding. 14 patients showed remnants of conception after 24 hours of treatment that
was diagnosed by vaginal sonar and clinically by unchanged uterine size and
persistent vaginal bleeding, so D & C was done to evacuate the contents
completely. One patient refused to complete the treatment so D & C was
done.
In the oral group, the
number of cases with complete evacuation by misoprostol was 31 patients (62%)
with failure of about 19 cases (38%). These were: 3 cases showed an attack of
severe vaginal bleeding after 2 4 tablets misoprostol intake. The bleeding
caused hypotension and urgent D & C was done to stop the bleeding. 16
patients showed remnants of conception after 24 hours of the treatment, so D and
C also was done to evacuate the remnants completely.
It was found that after
one tablet (200 ug) only 2 patients in rectal group and one patient in oral
group showed complete evacuation. After 2 tablets 9 patients in rectal group
and 7 patients in oral group showed complete evacuation. After 3 tablets 22
patients in rectal group and 22 in oral group showed complete evacuation.
The factors affecting
misoprostol response in rectal and oral
groups are shown in table (2). The side effects developing during intake of
misoprostol orally and rectally are shown in table (3).
DISCUSSION
In many
parts of the world there is a strong preference among gynecologists to rely on
surgical evacuation for the management of incomplete abortion. Why so many
specialists have adopted surgery as the standard procedure seems determined by
custom and rooted in history rather than being an evidence-based choice.
The present study showed
that the use of misoprostol was associated with success rate up to 66% in the
rectal group compared to 62% in the oral group. This matches well with the
result of other investigators (8) who used misoprostol 200 ug/4hs rectally for
a maximum 4 doses in treatment of incomplete abortion and the success rate was
60%. Also the success rate in our study was similar to (9) in which oral
misoprostol was used in a dose of 400 ug every 4 hours up to a total dose of
1200 ug with a success rate of 65 75%.
It also found that the
dose of 200ug misoprostol every 4 hours (orally and rectally) for a maximum of
3 doses was not only effective in complete evacuation but also had low
incidence of side-effects especially vomiting diarrhea and bleeding.
Gestational
age and the initial uterine size were the most important factors as most cases
with gestational age and initial uterine size lesser than 10 weeks showed
complete evacuation with a high success rate but the maternal, body weight and
parity were not important. Other investigators found that, the gestational age
and the initial uterine size also were the most important factors in evacuation
of the uterus in case of spontaneous abortion (10).
As regards the side
effects developing during misoprostol intake compared with the side effects of
the surgical treatment it was found that the complication of highest rate was
nausea as it occurred in 46% in oral group and 42% in rectal group as compared
to only 6% with D&C. Vomiting was a complication in 14% in rectal group and
in 18% oral group and in only 4% in D&C. Diarrhea occurred in 6% in rectal
group and 8% in oral group. Vomiting and diarrhea were mild and deserved no
treatment. The abdominal colic occurred in a high percentage of the rectal
group (86%) and the oral group (84%) but with D&C it was 14%.
On the other hand in
(Chung et al, 2001) study using oral misoprostol in the treatment of
incomplete abortion, the side effects were nausea (68%), vomiting (34%),
diarrhea (72%), abdominal colic (85%).
There was no statistical
significant difference between rectal and oral group as regard the number of
tablets of misoprostol needed for complete evacuation. Other investigators used
misoprostol orally and rectally in treatment of incomplete abortion (11). They
found that, the number of misoprostol tablets needed for complete evacuation by
rectal route was significantly lesser than oral route as 77% of patients showed
complete evacuation after 3 tablets with rectal group versus 63% in oral group.
In this study the difference in the number of misoprostol tablets needed for
complete evacuation in oral and rectal groups was not clear as the study was
done on small number of patients so the study must be repeated on large number
of patients to show the difference.
According to the present
study, the rectal route of misoprostol was equally effective like the oral
route with no significant difference in side effects. So, we may conclude that
misoprostol whether by oral or rectal route seems to be an effective as a non
invasive method for evacuation of the uterus in women with retained products of
conception. Further studies are needed to study the effect of higher doses of
misoprostol to avoid the need of surgical evacuation.
REFERENCES
-
Cowett
AA, Golub RM, Grobman WA. Cost-effectiveness of dilation and evacuation versus
the induction of labor for second-trimester pregnancy termination. Am J Obstet
Gynecol. 2006 Mar;194(3):768-73
-
Adolfsson A,
Larsson PG. Cumulative incidence of previous spontaneous abortion in Sweden in
1983-2003: a register study. Acta Obstet Gynecol Scand. 2006;85(6):741
-
Creinin
MD, Huang X, Westhoff C, Barnhart K, Gilles JM, Zhang J; National Institute of
Child Health and Human Development Management of Early Pregnancy Failure Trial.
Factors related to successful misoprostol treatment for early pregnancy
failure. Obstet Gynecol. 2006 Apr;107(4):901-7.
-
Nguyen
TN, Blum J, Durocher J, Quan TT, Winikoff B. A randomized controlled study
comparing 600 versus 1,200 microgram oral misoprostol for medical management of
incomplete abortion. Contraception. 2005 Dec;72(6):438-42
-
Tang
OS, Ho PC. The pharmacokinetics and different regimens of misoprostol in early
first-trimester medical abortion. Contraception. 2006 Jul;74(1):26-30.
-
Ngai
SW, Tang OS, Lao T, Ho PC. Oral misoprostol versus placebo for cervical
dilatation prior to vacuum aspiration in first trimester pregnancy. Hum
Reprod 1995;10: 12201222.
-
Ngai
SW, Yeung KC, Lao T, Ho PC. Oral misoprostol versus vaginal gemeprost for
cervical dilatation prior to vacuum aspiration in women in the sixth to twelfth
week of gestation. Contraception 1995;51: 347350.
-
Koopersmith
TB, Mishell DR Jr. The use of misoprostol for termination of early pregnancy.
Contraception. 1996 Apr;53(4):238-42
-
Chung
TK, Lee DT, Cheung LP, Haines CJ, Chang AM. Spontaneous abortion: a randomized,
controlled trial comparing surgical evacuation with conservative management
using misoprostol. Fertil Steril. 1999 Jun;71(6):1054-9.
-
De Jonge ET, Makin JD,
Manefeldt E, De Wet GH, Pattinson RC. Randomized clinical trial of medical
evacuation and surgical curettage for incomplete miscarriage. BMJ. 1995 Sep
9;311(7006):662
-
Pandian Z, Ashok P,
Templeton A. The treatment of incomplete miscarriage with oral misoprostol.
BJOG, 2001 Feb;108(2):213-4.
Copyright © Middle East Fertility Society
|