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Biomedical subjects

A Velazco

Publications and source records attributed to A Velazco.

At least 19 recordsLinked to original sources

Oral and vaginal misoprostol 800 microg every 8 h for early abortion.

The objective of the study was to evaluate the efficacy and safety of 800 microg misoprostol (Cytotec) every 8 h for 24 h for pharmacological abortion; the treatment was repeated if abortion did not occur in the first 24-h interval. The first misoprostol doses were always self-administered into the vagina; the second and third doses could be administered orally or vaginally depending on the amount of bleeding. Four-hundred and fifty-two women with gestations between 36 and 63 days were recruited into the study. The main outcomes assessed were: successful abortion (complete abortion without surgery), side effects, mean drop in hemoglobin, vaginal bleeding and mean time of return of menstruation. Complete abortion occurred in 409/452 (90.5%; 95% confidence interval [CI] 87%, 93%) patients. Medication to relieve symptoms was administered to all women before the first misoprostol dose. Vaginal bleeding lasted 15.9 +/- 4.4 days. The mean drop in hemoglobin, measured 14 days after abortion, was statistically significant (p = 0.0001) but without clinical relevance. According to the results obtained, 800 microg of misoprostol administered every 8 h for 24 h could be a valid method for abortion for up to 9 weeks of gestation.

Abortifacient Agents, Nonsteroidal↗

Vaginal misoprostol 1000 microg for early abortion.

The objective of this study was to evaluate the safety and efficacy of 1000 microg misoprostol vaginally (Cytotec) self-administered into the vagina for medical abortion. Three-hundred women with gestations between 42 and 63 days, with previous written consent, received vaginal misoprostol every 24 h up to a maximum of three doses for abortion. Outcome measures assessed included: successful abortion (complete abortion without surgery), side effects, decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time of returning of menses. Complete abortion occurred in 279/300 (93.0%, 95% CI 90, 96) patients. Medication to relieve symptoms was administered to all subjects after every misoprostol dose. Vaginal bleeding lasted 14.7 +/- 5.4 days. Mean expulsion time was 8.1 +/- 3.0 h for those who aborted after the first misoprostol dose. The mean drop in hemoglobin was statistically significant (p = 0.0001) but without clinical relevance. The frequencies of nausea and diarrhea were high. According to the observed outcomes, 1000-microg misoprostol vaginally could be a valid method to terminate pregnancies up to nine weeks gestation.

Abortifacient Agents, Nonsteroidal↗

Misoprostol for abortion at 9-12 weeks' gestation in adolescents.

The objectives of the present clinical study were to evaluate the safety and efficacy of misoprostol (Cytotec), self-administered into the vagina for medical abortion, in adolescents under 18 years ofage. A group of 150 adolescents with gestations between 63 and 84 days, with previous written consent from the patient and parents or guardians, received 800 microg of vaginal misoprostol every 24 h, up to a maximum of three main doses, for abortion. Outcomes assessed included successful abortion (complete abortion without surgery), side-effects, decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time for the return of menses. Complete abortion occurred in 126/150 (84.0%, 95% confidence interval 77-89) patients. The frequencies of nausea and vomiting were statistically significantly higher when compared to those obtained for adult females. Vaginal bleeding lasted for 13.2 +/- 3.8 days (median 13 days, range 1-22 days). The mean expulsion time was 8.0 +/- 3.4 h (median 8 h, range 1-14 h) for all subjects who aborted after the first misoprostol dose. The mean drop in hemoglobin was statistically significant (p = 0.001), but without clinical relevance. From the high abortion rate obtained, we concluded that misoprostol alone is a valid method for terminating unwanted pregnancies at 10-13 weeks' gestation in adolescents under 18 years of age in the absence of mifepristone.

Abortifacient Agents, Nonsteroidal↗

Oral versus vaginal misoprostol for cervical priming in first-trimester abortion: a randomized trial.

The objective of this study was to compare the oral and vaginal administration of misoprostol for cervical priming before surgical abortion up to 63 days' gestation. A total of 900 pregnant women, with ages ranging from 18 to 42 years, who asked for pregnancy termination, were included in this study. Women were randomly allocated to one of the following groups: oral administration of 400 microg misoprostol, 8 h before aspiration; and vaginal self-administration of 400 microg misoprostol, 4 h before aspiration. During admission, all subjects were checked on a 15-min basis. The preoperative cervical dilatation achieved was the main outcome assessed. The cervix was dilated (Hegar > or = 8) in 348 (78%) subjects from the oral treatment group and in 391 (87%) women from the vaginal treatment group; this difference was statistically significant (p = 0.0004). The mean dilatation achieved in the oral treatment group was 8.1 mm (SD 1.6 mm) and it was 8.5 mm (SD 1.5 mm) in the vaginal treatment group; this difference was statistically significant (p = 0.0001). The frequencies of side-effects such as nausea, vomiting, diarrhea and chills reported by women from the vaginal misoprostol group were 10, 8, 18 and 4 times lower, respectively, than those reported by subjects from the oral misoprostol group. In conclusion, vaginal self-administration of misoprostol was the best administration route, as it obtained the same or greater priming effectiveness of the cervix in half the time with a much lower frequency of side-effects.

Abortifacient Agents, Nonsteroidal↗

Vaginal misoprostol 600 microg for early abortion.

The objective of this study was to evaluate the efficacy and safety of the vaginal self-administration of 600 microg misoprostol up to a maximum administration of three doses in a 24-h period, one every 8 h, for abortion up to 9 weeks' gestation. A group of 90 voluntary women with gestations from 35 to 63 days participated in the study. All women who aborted received a single additional dose of 600 microg misoprostol. Outcome measures included successful abortion (complete abortion without requiring surgical procedure) and side-effects. Complete abortion occurred in 57/89 (64%, 95% confidence interval 53-74%) subjects. The mean expulsion time was 7.4 +/- 3.8 h (median 7.2 h, range 3-20 h) for all women who aborted within the first 24 h of the administration of misoprostol. Thirty-two cases failed to abort, 28 cases due to failure of the method, of which 24 had a negative cardiac rhythm after the third dose, and four cases due to the doctor's decision. The results obtained in this study led us to the conclusion that the 600-microg misoprostol dose regimen was not adequate to produce a high or an acceptable abortive efficacy.

Abortifacient Agents, Nonsteroidal↗

Misoprostol for abortion up to 9 weeks' gestation in adolescents.

The objectives of the present clinical study were to evaluate the safety and efficacy of misoprostol (Cytotec) self-administered into the vagina for medical abortion in adolescents under the age of 18 years. After obtaining written consent from the patients and parents or guardians, a group of 150 adolescents with gestations between 35 and 63 days received 800 microg of vaginal misoprostol every 24 h, up to a maximum of three main doses, for abortion. Outcomes assessed included successful abortion (complete abortion without surgery), side-effects, decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time for the return of menses. Complete abortion occurred in 133/150 (88.7%, 95% confidence interval 82-93) patients. The frequencies of nausea, vomiting and diarrhea were statistically significantly higher when compared to those obtained for adult females. Vaginal bleeding lasted for 12.7 +/- 5.7 days (median 12 days, range 1-23 days). The mean expulsion time was 6.8 +/- 2.4 h (median 6 h, range 3-14 h) for those who aborted after the first misoprostol dose. The mean time for the return of menses, for those who aborted with misoprostol, was 34.7 +/- 3.4 days. The mean decrease in hemoglobin was statistically significant (p = 0.001), but had no clinical relevance. Taking into account the high abortion rate obtained, we could conclude that misoprostol alone is a valid method for terminating unwanted pregnancies in adolescents under the age of 18 years.

Abortifacient Agents, Nonsteroidal↗

Early abortion with 800 micrograms of misoprostol by the vaginal route.

The objective of this study was to confirm the effectiveness and safety of self-administration of misoprostol every 24 h, for abortion up to 9 weeks of gestation. A group of 720 volunteer subjects with gestations from 35 to 63 days received 800 micrograms of vaginal misoprostol every 24 h up to a maximum of three main doses for abortion. Outcome measures assessed included successful abortion (complete abortion without requiring surgery), side effects, decrease in hemoglobin, mean time of vaginal bleeding, and mean time of return of menses. Complete abortion occurred in 644 of 720 (89.4%, 95% CI 87, 92) subjects. The mean decrease in hemoglobin was statistically significant (p = 0.0001). There were 14 subjects with clinically significant decreases in hemoglobin, but only two required transfusions. Vaginal bleeding lasted 6.7 +/- 3.9 days, spotting 8.1 +/- 4 days, and total bleeding 14 +/- 5.3 days. Mean expulsion time was 8.0 +/- 3.4 h. Although mifepristone remains unavailable, given the low price and availability of misoprostol in > 72 countries of the world, this latter drug constitutes an abortion alternative, provided that a minimum clinical network is nearby or accessible.

Abortifacient Agents, Nonsteroidal↗

25 mg or 50 mg of oral methotrexate followed by vaginal misoprostol 7 days after for early abortion: a randomized trial.

BACKGROUND: Several combinations of oral or intravenous methotrexate plus vaginal misoprostol have been used for early abortion with success rates varying widely. So far, any study has evaluated the efficacy and safety of lower doses of oral methotrexate followed by vaginal misoprostol for early abortion. OBJECTIVES: To evaluate the efficacy and safety of methotrexate 25 or 50 mg orally and 800 micrograms of misoprostol vaginally 7 days after the methotrexate for abortion at </=56 days of gestation. STUDY DESIGN: Three-hundred and ten pregnant women seeking elective abortion were randomly allocated to receive 25 mg (group I) or 50 mg (group II) of methotrexate orally and 800 micrograms of misoprostol vaginally 7 days after the methotrexate. The misoprostol dose was repeated 48 and 96 h later if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side effects and vaginal bleeding. Relative risks were used for the comparison between the outcomes from both treatment regimens. RESULTS: In group I aborted 135/148 cases (91%, 95% CI 85, 95%), and 139/154 cases (90%, 95% CI 84, 94%) aborted in group II (relative risk [RR] = 1.01, RR 95% CI 0.94, 1.09). CONCLUSIONS: The two treatment regimens showed the same efficacy and safety, so it would be advisable at least to use the smaller methotrexate dose, i.e. 25 mg.

Abortifacient Agents, Nonsteroidal↗

Vaginal misoprostol for abortion at 10-13 weeks' gestation.

OBJECTIVE: The effectiveness and safety of misoprostol have been reported for abortion up to 22 weeks' gestation. The objective of this study was to demonstrate the effectiveness and safety of self-administration of misoprostol every 12 h, without the need of postexpulsion systematic curettage, in late first-trimester abortions (10-13 weeks' gestation). METHODS: A group of 180 women with gestations from 64 to 91 days, self-administered 800 micrograms of vaginal misoprostol every 12 h for a maximum of three doses without performing postexpulsion systematic preventive curettage. Outcome measures included successful abortion (complete and incomplete abortion without requiring a surgical procedure), side-effects, mean expulsion time and vaginal bleeding. RESULTS: Successful abortion occurred in 153/180 (85%) subjects (95% confidence interval (CI) 79-90). The decrease of hemoglobin was statistically significant (p = 0.0001) but clinically unimportant: 12.1 mg/dl (SD 1.1) before treatment and 11.7 mg/dl (SD 1.1) afterwards. The mean expulsion time for patients who aborted after the first dose was 8.3 +/- 3.6 h (median 8 h, range 2-12 h). Vaginal bleeding lasted 6 +/- 3 days, spotting 7 +/- 3 days and total bleeding 13 +/- 4 days. The median dose of misoprostol administered was 1780 micrograms (range 1400-3000 micrograms). CONCLUSIONS: The high degree of acceptability, its efficacy and the fact that postabortion systematic curettage was not needed make misoprostol a suitable alternative to the currently available methods for termination of pregnancy at 10-13 weeks' gestation.

Abortifacient Agents, Nonsteroidal↗

Oral methotrexate and vaginal misoprostol for early abortion.

A prospective trial including 300 pregnant women seeking elective abortion was conducted to evaluate the safety and efficacy of methotrexate and misoprostol for abortion at < or = 63 days' gestation. Subjects received methotrexate 50 mg orally and were randomly allocated to receive 800 micrograms of misoprostol vaginally 3, 4, or 5 days after administration of the methotrexate. The misoprostol dose was repeated 48 and 96 h later if abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure) and side effects. Complete abortion occurred in 273 of 300 patients (91%, 95%, CI 87, 94%) patients. No significant statistical differences were found in the success rates when misoprostol was given days 3, 4, or 5 after the administration of methotrexate (p = 0.69). Vaginal bleeding lasted 7.1 +/- 3.8 days, spotting 4.1 +/- 2.5 days, and total bleeding 11.2 +/- 4.1 days. Side effects for methotrexate were minimal, whereas, for misoprostol they were mild and transient except for pain. The use of methotrexate and misoprostol together could be an alternative to the intramuscular use of methotrexate or the use of antiprogestins and prostaglandin for medical abortion.

Abortifacient Agents, Nonsteroidal↗

Vaginal misoprostol for late first trimester abortion.

A group of 120 women with gestations from 64 to 84 days received 800 micrograms of vaginal misoprostol every 24 h for a maximum of three doses without performing postexpulsion systematic preventive curettage. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side effects, and mean time of expulsion and vaginal bleeding. Complete abortion occurred in 104 of 120 (87%, 95% CI 79, 92) subjects. The decrease of hemoglobin was statistically significant (p = 0.0001) but clinically unimportant: 12.2 mg/dL (SD 1.1) before treatment and 11.6 mg/dL (SD 1.0) after treatment. Statistically significant differences were found only between the success rates for white women in comparison with nonwhite women, in which case the success rates were higher for white than for nonwhite women. Vaginal bleeding lasted 8 +/- 5 days, spotting 4 +/- 3, and total bleeding 12 +/- 4 days. The acceptable expulsion time, the fact that postabortion systematic curettage was not needed, the clinically insignificant hemoglobin loss, and the success rate obtained show that misoprostol administered vaginally may be a valid method for interrupting gestations of 10-12 weeks.

Abortifacient Agents, Nonsteroidal↗

Vaginal misoprostol for early second-trimester abortion.

OBJECTIVES: To demonstrate the effectiveness and safety of misoprostol without the need of postexpulsion systematic curettage in early second-trimester abortions, i.e. at 13-15 weeks' gestation. METHODS: A group of 151 women, with gestations from 85 to 105 days, received 800 micrograms of vaginal misoprostol every 25 h for a maximum of three doses, without having postexpulsion systematic preventive curettage performed. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side-effects, mean expulsion time and mean time of vaginal bleeding. RESULTS: Complete abortion occurred in 121/151 subjects (80%; 95% confidence interval, 78-87%). The decrease in hemoglobin was statistically significant (p = 0.0001), but without clinical relevance (11.8 mg/dl (SD, 0.9) before treatment and 11.4 mg/dl (SD, 1.0) afterwards. No statistically significant differences were found between the success rate and any of the women's characteristics. Vaginal bleeding lasted 6 +/- 3 days, spotting 6 +/- 3 days, and total bleeding 12 +/- 5 days (median, 11 days; range, 1-29). CONCLUSIONS: The acceptable expulsion time in 80% of the cases, the fact that postabortion systematic curettage was not needed, the clinically insignificant hemoglobin loss and the abortion rate obtained, show that misoprostol by vaginal administration may be an alternative for interrupting gestation in the early second trimester of pregnancy.

Abortifacient Agents, Nonsteroidal↗

The use of misoprostol for termination of early pregnancy.

Misoprostol is a prostaglandin analogue with uterotonic properties. A group of 141 women with less than 70 days of pregnancy received up to 3 doses of 800 micrograms of misoprostol every 48 hr. Failure was defined as the need for surgical abortion and success as the complete expulsion of the products of conception pharmacologically. In total, 132 cases (93.6%, 95% CI 89.4-97.8) aborted pharmacologically and 9 cases (6.4%) failed. The decrease in hemoglobin was statistically significant (p = 0.001) but without clinical repercussions; before treatment: 11.95 mg/dI (SD 1.19) and after: 11.14 (SD 1.20). Statistically significant differences were not noticed between success rates and failures in relation to gravidity, parity, previous abortions, race, or age, but were noticed with a gestation upwards of 9 weeks (p = 0.01). The third dose of misoprostol showed very little efficacy. The convenience of using more frequent doses and shortening the treatment, combined with different routes of administration, are discussed.

Abortifacient Agents, Nonsteroidal↗

Misoprostol 3, 4, or 5 days after methotrexate for early abortion. A randomized trial.

A randomized trial was conducted including 287 pregnant women seeking elective abortion to compare the efficacy of misoprostol given 3, 4, or 5 days after methotrexate for abortion at < or = 63 days' gestation. Subjects received 50 mg/m2 methotrexate intramuscularly and were randomly allocated to self-administer vaginally 800 micrograms of misoprostol 3, 4, or 5 days after the methotrexate. The misoprostol dose was repeated 48 and 96 h later if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), and side effects. Eighty-six cases (93%; 95% confidence interval [CI] 85%-97%) aborted in Group I; 90 cases (92%; 95% CI 84%-96%) aborted in Group II (relative risk [RR] = 1.09; RR 95% CI 0.38-3.14); and 89 (93%; 95% CI 86%-97%) cases aborted in Group III (RR = 0.97; RR 95% CI 0.33-2.87). No significant statistical differences were obtained for the success rates when misoprostol was given days 3, 4, or 5 after the administration of methotrexate (p = 0.97) nor with any of the characteristics of the subjects. Complete abortion occurred in 265/287 (92%; 95% CI 89%-95%) patients. Twenty-two cases (8%; 95% CI 5%-11%) resulted in failure. Side effects for methotrexate were minimal while for misoprostol they were moderate. This combination could be an alternative to surgical abortion or the use of antiprogestins and prostaglandins for medical abortion.

Abortifacient Agents, Nonsteroidal↗

The use of misoprostol for abortion at < or = 9 weeks' gestation.

OBJECTIVE: To verify the efficacy and safety of misoprostol for abortion at < or = 63 days' gestation. METHOD: A total of 175 women seeking elective abortion at < or = 63 days' gestation received 800 micrograms of misoprostol vaginally. This dose was repeated at 48 and 96 h if abortion did not occur. Afterwards, up to three additional 600- or 400-micrograms doses of misoprostol were administered if the uterus was not empty, as judged by ultrasound. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side-effects and vaginal bleeding. RESULTS: Complete abortion occurred in 161/175 (92.0%; 95% CI 87-96%) subjects and 14/175 (8.0%; 95% CI 4-13%) cases failed. The immediate success rate was 77.7% with the first dose, 13.7% with the second dose and 0.6% with the third dose. The decrease in hemoglobin was statistically significant (p = 0.009) but without clinical relevance; before treatment: 11.94 mg/dl (SD 1.60) and after treatment: 11.64 mg/dl (SD 1.08). No significant differences were obtained between success rates and failures in relation to age, gravidity, parity, previous abortions, race, gestational age and side-effects. The third main dose of misoprostol showed very little efficacy. Vaginal bleeding lasted 5.5 +/- 2.8 days, spotting 5.7 +/- 3.1 days and total bleeding 11.2 +/- 3.0 days. CONCLUSIONS: The success percentage attained shows that 800 micrograms of misoprostol administered vaginally effectively causes abortion at < or = 63 days' gestation.

Abortifacient Agents, Nonsteroidal↗

Soft-tissue reconstruction of the leg associated with the use of the Hoffmann external fixator.

Soft-tissue injuries and defects associated with severe fractures of the tibia treated with the Hoffmann external fixator were reviewed. Of 84 cases of open tibia fractures (classified as Gustilo's Type II and III), 54 patients with 55 injured limbs required soft-tissue reconstruction other than skin grafts or small rotational flaps. These 55 cases were constructed with 37 local musculocutaneous flaps (20 gastrocnemius, 17 soleus and other smaller muscle flaps), 15 free musculocutaneous flaps (14 latissimus dorsi, and one tensor fascia lata), and three medial gastrocnemius cross leg flaps. In all cases the soft-tissue reconstruction was done with the external fixator in place. All but three of the musculocutaneous flaps healed with no problems (94%). Bony healing was found in 30 cases (69.09%) at 18-month followup. There was one amputation after two failed local flaps and three late amputations due to patient's request (infected nonunion). There was a nonunion rate of 25.45% (14 cases) at 18 months postinjury. The Hoffmann external fixator has allowed bony stabilization and has not precluded the subsequent soft-tissue reconstruction or bone grafting. Muscle and musculocutaneous flaps, both local and free, have been employed in the reconstruction of the leg with minimal interference from the Hoffmann device.

Adolescent↗