J. CARBONEL (Spain) uses this method, with 3 doses of 8OO µg misoprostol
alone. The rate of success ranges from 90 to 92% in pregnancies up to 63
days of amenorrhoea (LMP). This technique is less expensive than that using
INDUCED ABORTION IN GESTATIONS FROM 19 TO 24 WEEKS OR MORE WITH 200 mg of MIFEPRISTONE + MISOPROSTOL + OXITOCIN
*J.LL Carbonell Esteve, *L. Várela, et al
*Clínica Mediterránea Medica Valencia, Castelló (Spain)
INTRODUCTION: Although some authors perform the D and E up to 22-23 weeks gestation, it is not advisable to use it beyond 19-20 weeks, since the risks and difficulties increase considerably with gestation. To determine a suitable protocol with maximum possible safety and efficacy is one of the burning scientific topics in termination of pregnancies of second late trimester and third trimester. Without any doubts mifepristone and misoprostol are indispensable in such protocol.
MATERIAL AND METHODS: They were administered mifepristone 200 mg orally 24-48 hours before vaginal administration of 800 µg of wet misoprostol + 2 dilapan shafts according to cervical conditions. 3-4 hours later the cervix was evaluated and if shafts were loose, a second dose of 600 µg of vaginal misoprostol was inserted or it was performed an artificial rupture of membranes (dilation 2-3 cm) and oxitocin infusion was established (6-8 drops by minute in a solution of 500 cc of ClNa with 30 U.I. of oxitocin). In an hour basis the cervix was examined and several medications were used to relieve pain and ripening the cervix. General sedation was used at expulsion. A complete hemogram with fibrinogen and TPTA 2 hours late were performed. Patients with cesarean section or previous uterine scar were not excluded.
RESULTS: 90 subjects between with 19 to 23.5 weeks gestation were successfully interrupted with the above protocol; 2 of them (20,4 and 20,5 weeks gestation) were failure cases at 32 and 31 hours, respectively, and were terminated by D and E. Only 30% of the cases received mifepristone before 24 hours. They were malformed 52.4% and 47.6% were voluntary abortions. The most frequent malformation was Down’s syndrome. The mean expulsion time was 5.5 hours, range 1.30-25 hours. There was a moderate hemorrhage by an atone uterus and the patient was discharged the following day, and an uterine rupture that forced to perform an urgent hysterectomy in a patient with a 19 years old cesarean section.
DISCUSSION: The use of mifepristone previously to the administration of prostaglandins improves significantly the cervical conditions and reduces in 50% the mean expulsion time, allowing that more than 60% of the cases can be discharged 6 hours post expulsion of the fetus and therefore to spend the night at home. Patients with previous cesarean section should be object of a different protocol, perhaps with less and maybe repeated doses of misoprostol. In the international bibliography there is reported a case of uterine rupture using a single 200 µg dose of vaginal misoprostol. It is urgent to determine with randomized clinical trials a proper dosing protocol for cases with previous uterine scar.
IS SPAIN A DEMOCRATIC COUNTRY CONCERNING RIGHTS TO ABORTION?
J.LL Carbonell Esteve
Clínica Mediterránea Medica Valencia, Castelló (Spain)
The answer without a doubt TO this question is NO. Given that, in 98,99% of the abortions in our country, the woman should be authorized by a psychiatrist to carry out her abortion. The supposition of serious danger for the woman's psychic health that contemplates the Spanish law of abortion is the “legal strainer” for which is carried out more than 90% of those almost 70.000 annual abortions of social character or for free will of the woman. Therefore, this not is tinged since in the practice the legal strainer that supposes an insult and confiscation of the sovereignty and the woman's freedom, allows that in the reality the abortion in our State is practically FREE as in other countries of the truly democratic Europe. Also, more than 60% of the cases the woman should pay the cost of her abortion.
More than 2.500 judicial diligences have opened up crime of illegal abortion of course and more than 20 trials have taken place so far for the same reason, since the promulgation of the abortion law in 1985. In the last sentence of the Supreme Tribunal of the year 2003, after 10 years of judicial prosecution and provisional freedom for 2 doctors from different clinics and for the own woman that aborted, and concluded that the abortion was “legal” although a psychiatry specialist did not authorize it but by a general doctor Specialist in Public Health (Dr. J. Carbonell). The woman was acquitted and alone the doctor that practiced the abortion was condemned (Dr. J. Vives) for a supposed crime of professional negligence.
It is hope that this serious situation changes with the new abortion law that the PSOE, at the moment in governs has committed openly as necessary to promulgate, so that it puts an end to this situation of serious artificial lack of defense, so much for doctors as for women themselves.
MIFEPRISTONA 200 MG + 600 µg OF SUBLINGUAL VERSUS VAGINAL MISOPROSTOL FOR SURGICAL ABORTION BETWEEN 12 TO 20 WEEKS GESTATION.
J.LL Carbonell, L. Várela, et al.
Clínica Mediterránea Medica. Valencia, Spain
INTRODUCTION: The use of vaginal misoprostol for ripening the cervix before second trimester abortions performed with the technique of Dilation and Evacuation (D and E), has represented a significant advance in the practice it of such procedure. Few carried out studies exist, using 200 mg of mifepristona before the administration of misoprostol. One of the legal indications of mifepristone is its use as a sensibilizing agent to the action of prostaglandins for second trimester abortions. To study the efficacy of sublingual versus vaginal misoprostol was the object of this study.
MATERIAL AND METHODS: 600 women with gestations between 12 to 20 weeks were randomly allocated to receive 200 mg of oral mifepristone and 15-48 hours later 600 µg of sublingual or vaginal misoprostol. Vaginal misoprostol (group 1) was inserted by doctors into the vaginal fornix and the buccal tablets (group 2) were placed by subject themselves sublingually and the other tablets inside the cheeks. In both groups, D and E was performed between 1 and 1.30 hours after the administration of misoprostol. Patients with previous cesarean section were not excluded. It was measured: 1) effect of mifepristone 2) achieved dilation, 3) side effects of misoprostol, and 4) duration of post abortion bleeding. The effect of mifepristone was assessed, before and after treatment, by means of vaginal exam detailing: position, length, consistency and dilation of the cervix.
RESULTS: So far they 200 women were treated with this protocol. In 91% of patients, the cervical conditions were improved after the administration of mifepristone. There was not any side effect of interest. The mean dilation reached was of 12 and 13 mm, in groups 1 and 2, respectively. Nausea, vomiting, chills/fever were present in 7,8% and 15%, vomiting 3% and 4,5%, fever/chills 30% and 36%, in groups 1 and 2, respectively. These signs and symptoms were always of moderate and acceptable intensity as referred by 91% of patients. After the administration of misoprostol and before the D and E there were 4% and 5% in groups 1 and 2, respectively, of spontaneous expulsions, that is to say pharmacological abortions.
DISCUSSION: Comparing with the well-known experience the fact of administering mifepristone 200 mg previously supposes an important advance in what concerns to the improvement of the cervical conditions for the realization of a D and E, so that once administered the misoprostol the necessary time of wait to perform the D and E decreases in about f 50%, otherwise they begin to take place pharmacological abortions. The reached dilation is very superior to the one obtained with the administration of misoprostol alone, being the dilation softer and physiologic, also shortening the surgical and anesthetics times. The sublingual route has practically demonstrated to be as effective as the vaginal one, that which represents a considerable advance in what concerns to the patient's comfort. More studies should be carried out in order to demonstrate the efficacy and safety of sublingual administration of misoprostol that presents fewer incidences of side effects due to the elimination the enterohepatic course and with similar dilatory efficacy as the vaginal route.
Mifepristone 10 mg for emergency contraception up to 144 hours after an
Carbonell JL,* García R,† Breto A,† Llorente M,* Marí JM,* Sánchez E,* Salvador I,*
†Eusebio Hernández Gyneco-Obstetric Teaching Hospital, Havana, Cuba.
*Mediterrania Medica Clinic, Valencia, Spain.
Background: Mifepristone 10 mg has proved to be an effective emergency contraceptive
when administered up to 120 hours after unprotected coitus. We assessed whether the
same effectiveness can be achieved if mifepristone is administered in a longer postcoital
interval (144 hours). Methods: Between May 2003 and February 2005, in the Eusebio
Hernández Gyneco-Obstetric Teaching Hospital in Havana, Cuba, we conducted a single-
arm trial to evaluate the effectiveness of 10 mg mifepristone for emergency contraception
up to 144 hours (6 days) after unprotected coitus, A total of 635 women who requested
emergency contraception after a single act of unprotected intercourse were included in the
study. Results: After treatment there was a total of 7/635 (1.1%) pregnancies, 95% CI 0.4
– 2.3%. The prevented pregnancy fraction was 88.0% with 95% CI 77.1 – 95.1%. The
most common side effects reported by subjects were dizziness (6.1%) and nausea (4.9%);
vomiting was only reported by 0.6%. In 38/635 (6.0%) women menstruation was delayed >
7 days. Conclusions: Mifepristone 10 mg administered after unprotected sex can be an
effective method in emergency contraception with an acceptable profile of side effects, but
bigger studies are necessary to verify that it could be administered up to 6 days (144
hours) after an unprotected intercourse.
Misoprostol for cervical priming: Vaginal vs sublingual
Carbonell J. LL.,* Llorente M,* Barambio S.,† Sánchez E.,* Varela L.,* González G.,*
*Clínica Mediterrania Médica, Valencia, España
† Clínica Tutor Médica, Barcelona, España
Objectives: to assess the effectiveness and safety of mifepristone 200 mg 48 hours before
administering misoprostol 600 µg, vaginal versus sublingual route, prior to D&E in 12-to-
Design: Controlled randomized clinical trial. Setting: Clínica Mediterrania Médica,
Subjects: Women with 12-to-20-week pregnancies wanting a voluntary abortion under the
requirements of serious danger for the mother’s mental health and/or fetal malformations,
between 9 July 2004 and 9 February 2006.
Methods: 900 women were randomized to be included in one of the following 4 groups: I)
sublingual mifepristone 200 mg plus misoprostol 600 µg before D&E, II) vaginal
mifepristone 200 mg plus misoprostol 600 µg before D&E, III) sublingual 600 µg
misoprostol before D&E, and IV4) vaginal misoprostol 600 µg before D&E.
Main outcomes measured: The degree of cervical dilation achieved before D&E, surgical
time necessary to terminate the pregnancy and side effects of misoprostol.
Results: The average cervical dilation in the mifepristone groups was 12.5 ± 2.8 mm (IC
95% 12.3 – 12.8), versus 8.5 ± 3.2 mm (IC 95% 8.2 – 8.8) in those receiving only
misoprostol. Surgical time in the mifepristone sublingual misoprostol group was 11.9 ± 4.3
minutes versus 13.0 ± 5.3 in the sublingual misoprostol group without mifepristone,
(p=0.007); in the mifepristone vaginal misoprostol group the average surgical time was
12.3 ± 5.0 minutes, versus 13.0 ± 6.2 in the vaginal misoprostol group without
Conclusions: administering mifepristone before D&E with misoprostol in second-trimester
abortions makes surgery easy and, to a certain extent, lessens the risk of cervical injuries,
especially in D&E in advanced gestational periods.
Sublingual versus vaginal misoprostol 400 µg for cervical priming
Josep Lluis Carbonell1, J. Marí1, F. Valero2, M. Llorente1, I Salvador1, L Varela1, P Leal1,
A. Candel1, A Tudela1, M Serrano1, E Muñoz1,1Clinica “Mediterrania Medica”, Valencia, Castelló, Spain. 2Clínica “Ginemur”, Murcia,
Murcia Capital, Spain.
Objective: To compare the sublingual and vaginal administration of misoprostol for
cervical priming before first trimester surgical abortion. Design: Open, multicenter,
randomized trial. Locations: Four clinics in Spain: Valencia, Castelló, Murcia and Murcia
Capital. Participants: 1424 healthy pregnant women with amenorrhea ≤ 84 days who
voluntarily decided to terminate their pregnancies. Methods: Women were randomly
assigned to receive a single dose of 400-µg misoprostol sublingually or vaginally 1 to 3
hours before aspiration. Outcomes assessed: The cervix dilation before surgery and
surgical time needed for aspiration. They were also evaluated the incidence of side effects
such as nausea, vomiting, diarrhea, fever/chill and parestheses. Results: The mean
cervical dilation achieved was 6.8 ± 0.8 mm and 6.7 ± 0.9 for sublingual and vaginal
groups, respectively. Mean surgical time for the sublingual group was 7.0 ± 2.8 minutes
and 7.4 ± 2.5 for the vaginal group. Nausea, vomiting and diarrhea were more frequent in
the sublingual group. Conclusions: Both regimens had similar efficacy; however, the
sublingual route caused more side effects.
VAGINAL MISOPROSTOL 800 µG EVERY 12 HOURS FOR SECOND TRIMESTER ABORTION.*
J.LL. Carbonell Esteve,a J. Rodríguez,b et al.
aClínica “Mediterránea Medica”, Valencia Spain.
bHospital Docente Gineco-Obstetrico “Eusebio Hernandez”, Havana, Cuba
INTRODUCTION: Since Bugalho et al. published in 1992 the first study using doses of 800 µg of misoprostol for second trimester abortion, so far numerous studies have been carried out using different dose and administration intervals. Some of them have used 200 mg of mifepristone 48 hours before misoprostol and they have obtained significantly shorter expulsion times. An appropriate protocol to carry out abortions of more than 12 week gestation regarding efficacy and safety is yet to be determined.
MATERIAL AND METHODS: Subjects with a previous uterine scar were excluded. A total of 269 women between 12 and 20 weeks gestation received 800 µg of vaginal misoprostol every 12 hours up to a maximum of 3 doses. Side effects, duration of bleeding, expulsion time, etc. were measured. Success was defined as the complete expulsion of the fetus and placenta without curettage after expulsion.
RESULTS: Complete abortion occurred in 245/269 (91.1%, 95% CI 87%-94%). After the first misoprostol dose aborted 66,5% of subjects; 19% of subjects aborted after the second misoprostol dose; and 5,6% aborted after the third dose, totalling 91,1%. There were 24 (8.9%) failure cases according to protocol. Mean vaginal bleeding time was 15.7 ± 4.1 days. Chills, nausea and vomiting were the most frequent side effects, all of them mild and transient. There 13 blood transfusions due to vaginal bleeding.
CONCLUSIONS: Of the 13 transfusions, only 1.1% were correctly indicated, the rest of them were unnecessary according to hemoglobin values. The administration of 800 µg misoprostol doses every 12 hours could be to valid alternative for abortion beyond 12 weeks gestation, especially in those countries where mifepristone is not yet available.