LA CONSULTA SEMANAL

CONSULTA

1: BJOG  2002 May;109(5):561-5
A randomised placebo-controlled trial of vaginal misoprostol for cervical priming before hysteroscopy in postmenopausal women.
Fung TM, Lam MH, Wong SF, Ho LC.
Obstetrics and Gynaecology Unit, Princess Margaret Hospital, Lai Chi Kok, Hong Kong.
OBJECTIVE: To investigate the effectiveness of misoprostol given vaginally for cervical priming before hysteroscopy in postmenopausal women. DESIGN: Double-blind randomised controlled study. SETTING: Regional hospital, Hong Kong. PARTICIPANTS: One hundred women with postmenopausal bleeding scheduled for hysteroscopy from October 1998 to September 2001 were randomly assigned to receive either misoprostol or placebo vaginally before the operation. MAIN OUTCOME MEASURES: The number of women requiring cervical dilatation, outcome of hysteroscopy and side effects of the medication were assessed. RESULTS: Forty-eight women receiving misoprostol and 48 women receiving placebo were compared. The mean degree of endocervical diameter estimated by Hegar's dilator was similar between the treatment group and the control group. A similar number of women in the treatment group and the control group required cervical dilatation. The operative times for both groups were similar. The incidence of side effects was comparable in both groups. The most common side effects for misoprostol were febrile episodes and diarrhoea. There was no cervical tear nor uterine perforation encountered in both groups. The mean duration of hospital stay in both groups were similar. Subanalysis of results were similar in women receiving vaginal medication at least five hours before the operation. CONCLUSION: Vaginal misoprostol was not shown to reduce the need for cervical dilatation in postmenopausal women. It cannot convert diagnostic hysteroscopy from a hospital procedure into an office one in postmenopausal women with tight cervical os.

2: Am J Obstet Gynecol  2002 Jun;186(6):1237-1243
Factors affecting the likelihood of successful induction after intravaginal misoprostol application for cervical ripening and labor induction.
Wing DA, Tran S, Paul RH.
Division of Maternal-Fetal Medicine, Department of Obstetrics-Gynecology, University of Southern California, Keck School of Medicine.
OBJECTIVE: Our purpose was to determine whether maternal age, height and weight, parity, duration of pregnancy, cervical dilatation or Bishop score, and birth weight could be used to predict the likelihood of successful induction in women given intravaginal misoprostol.Study Design: A computerized database was compiled of 1373 pregnancies in which intravaginal misoprostol was given for cervical ripening and labor induction. Most of these women were placed on investigational protocols in which the dose of misoprostol administered was 25 to 50 &mgr;g and the dosing intervals ranged from 3 to 6 hours. No more than 24 hours of administration was permitted. Induction was undertaken in women with unfavorable cervical examinations (Bishop scores of 4 or less) and without spontaneous labor or ruptured membranes. Univariate and stepwise multiple regression analyses were performed to identify those factors associated with successful induction, defined as vaginal delivery within 24 hours of induction. RESULTS: Six hundred fifty-seven (48%) had successful induction. Parity (odds ratio [OR] 2.5, 95% CI 2.0-2.9, P <.0001), initial cervical dilatation (OR 1.9, 95% CI 1.6-2.3, P <.0001), Bishop score (OR 1.6, 95% CI 1.3, 1.8, P <.0001), and gestational age at entry (OR 1.3, 95% CI 1.1-1.5, P =.002) were significant at the.05 level for predicting successful induction. A multivariate stepwise logistic regression was then performed to evaluate each of these as independent predictors. Parity (OR 2.4, 95% CI 2.0-3.0, P <.0001), initial cervical dilatation (OR 1.7, 95% CI 1.4-2.1, P <.0001), and estimated gestational age (OR 1.3, 95% CI 1.1-1.6, P =.003) are significant independent predictors for successful induction, but initial Bishop score is not significant (P =.19) after adjustment for other significant predicting factors. CONCLUSIONS: The clinical characteristics of parity, initial cervical dilatation, and gestational age at entry are predictors of the likelihood of success of cervical ripening and labor induction with intravaginal misoprostol administration.

3: Am J Obstet Gynecol  2002 Jun;186(6):1124-1129
Cervical ripening and induction of labor with misoprostol, dinoprostone gel, and a foley catheter: A randomized trial of 3 techniques.
Barrilleaux PS, Bofill JA, Terrone DA, Magann EF, May WL, Morrison JC.
Departments of Obstetrics and Gynecology and Preventive Medicine, University of Mississippi Medical Center.
OBJECTIVE: The purpose of this study was to compare the efficacy of 3 different techniques of cervical ripening and induction.Study Design: Patients who required cervical ripening and induction were randomized to one of 3 groups: (1) supracervical Foley catheter and intravaginal dinoprostone gel, (2) supracervical Foley catheter and 100 &mgr;g oral doses of misoprostol, or (3) serial 100-&mgr;g oral doses of misoprostol. Intravenous oxytocin was administered when a protraction disorder of labor was identified. RESULTS: There were 339 women randomized. There was no significant difference in the time from first intervention to delivery in the 3 groups (P =.546). In each group, a similar percentage of women required oxytocin (P =.103). The rates of cesarean delivery were equivalent among the groups (P =.722). Rates of tachysystole were high but statistically equivalent among the 3 groups. There were no significant differences in Apgar scores or umbilical artery pH. CONCLUSION: Oral 100 &mgr;g serial doses of misoprostol, with or without the use of a supracervical Foley catheter, were equivalent to the use of a supracervical Foley catheter and serial 4-mg doses of dinoprostone gel for cervical ripening and the induction of labor.

4: Obstet Gynecol  2002 Jun;99(6):1080-4
The effect of tablet moistening on labor induction with intravaginal misoprostol: a randomized trial.
Sanchez-Ramos L, Danner CJ, Delke I, Kaunitz AM.
Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of Florida Health Science Center, Jacksonville, Florida 32209, USA. luis.sanchez@jax.ufl.edu
OBJECTIVE: To estimate whether a dosage of 50 microg of misoprostol tablets moistened with 3% acetic acid and administered intravaginally is more efficacious for labor induction than a similar dosage regimen using dry tablets. METHODS: A total of 177 women who presented with an indication for cervical ripening and labor induction were randomly assigned to one of two treatment groups: 1) intravaginal misoprostol in dry tablet form, or 2) intravaginal misoprostol moistened with 1 mL of 3% acetic acid solution. The primary outcome assessed was the interval from start of induction to vaginal delivery. To detect at least a 3.5-hour difference in the primary outcome with 80% power, 87 subjects were required in each group. RESULTS: Among 162 patients evaluated, 80 were allocated to the misoprostol dry group and 82 to the misoprostol moistened group. No significant difference was noted for the mean +/- standard deviation interval to vaginal delivery: 1130 +/- 636 minutes for the group who received dry tablets and 1004 +/- 636 minutes for those who received moistened misoprostol tablets (P =.25). Additionally, no statistically significant differences were noted between the groups with respect to need for oxytocin, proportion of patients delivered after a single dose, intrapartum complications (including tachysystole and uterine hyperstimulation), mode of delivery, or perinatal outcomes. CONCLUSION: Tablet moistening with 3% acetic acid solution does not seem to improve the efficacy of intravaginally administered misoprostol for labor induction.
Publication Types:
Clinical Trial

5: Obstet Gynecol  2002 Jun;99(6):1044-8
Oral versus vaginal misoprostol for labor induction.
Hall R, Duarte-Gardea M, Harlass F.
Department of Obstetrics and Gynecology, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas 79905, USA.
OBJECTIVE: To compare the safety and effectiveness of vaginal with oral misoprostol for induction of labor. METHODS: A total of 107 women with clinical indication for induction were randomly assigned to receive oral or vaginal misoprostol. Doses of 100 microg of oral or 25 microg of vaginal misoprostol were given every 3-4 hours. If cervical ripening or active labor did not occur, repeated doses of oral (100-200 microg) or vaginal (25-50 microg) were given until labor was established. RESULTS: Fifty-nine women received oral misoprostol, and 48 received vaginal administration. Delivery time was similar for the vaginal and oral arms (1074 +/- 488 minutes versus 930 +/- 454 minutes, P =.11). Parity was significantly different (P =.04) for the vaginal and oral groups. The cesarean delivery rate was similar for the vaginal and oral arms (17% versus 15%, P =.72). The number of medication administrations was consistent between groups. Birth weight was not different for patients in the control and treatment groups (vaginal 3281 +/- 507 g versus oral 3359 +/- 541 g, P =.44). Chorioamnionitis and tachysystole were comparable for the oral and vaginal groups. There was no statistical difference in neonatal outcomes. Similar proportions of infants were admitted to the well baby nursery and intermediate care nursery. CONCLUSION: These findings indicate that, in a closely supervised hospital setting with adequate monitoring, oral misoprostol has the potential to induce labor as safely and effectively as its vaginal analogue.
Publication Types:
Clinical Trial

6: Am J Obstet Gynecol  2002 May;186(5):876-9
The use of oral misoprostol as a cervical ripening agent in operative hysteroscopy: a double-blind, placebo-controlled trial.
Thomas JA, Leyland N, Durand N, Windrim RC.
Department of Obstetrics and Gynecology, University of Toronto, Mt Sinai Hospital, Ontario, Canada.
OBJECTIVE: The purpose of this study was to assess the effectiveness of oral misoprostol as a cervical ripening agent when used in operative hysteroscopy. STUDY DESIGN: This was a double-blind, placebo-controlled trial. Any patient undergoing an operative hysteroscopy (with a 9-mm to 10-mm hysteroscope) was considered eligible for the trial. Patients were randomly allocated, by means of computer-generated numbers, to receive either placebo or 400 microg of misoprostol 12 and 24 hours before surgery. The primary outcome measure in this study was the ease of cervical dilatation as measured by the largest-number Hegar dilator that could be inserted into the cervix without resistance. A subjective assessment of the ease of dilatation was also recorded on a Likert scale. Other demographic data including age, menopausal status, parity, and use of gonadotropin-releasing hormone (GnRH) analogues were also recorded. Adverse effects experienced and any other adverse outcomes were also recorded for each group. Logistic regression analysis was used to compare the two groups. RESULTS: Two hundred four patients were recruited into the study. There were no differences between the two groups in demographic variables. The misoprostol group demonstrated an increased ease of cervical dilatation (odds ratio [OR] 2.6; CI 1.28-5.29; P =.008). This was also demonstrated in the subgroup of patients who were menopausal or who had been pretreated with a gonadotropin-releasing hormone analog (OR 2.49; CI 1.11-5.58; P =.026), as well as in those who were premenopausal (OR 2.15; CI 1.04 4.45; P =.04). There were no differences between the two groups in the time required for dilatation (P =.08) or ease of dilatation (P =.12). Adverse effects were greater in the treatment group: diarrhea (28% vs 4%; P <.001), cramps (27% vs 1%; P <.0001), and bleeding (26% vs 1.3%; P <.001). CONCLUSIONS: Misoprostol demonstrates a benefit over placebo in the ease of cervical dilatation in premenopausal and postmenopausal women and in those pretreated with a gonadotropin-releasing hormone analog. Adverse effects were more common in the treatment group but did not preclude the patients from taking the medication.

Publication Types:
Clinical Trial

7: Am J Obstet Gynecol  2002 Mar;186(3):470-4
The optimization of intravaginal misoprostol dosing schedules in second-trimester pregnancy termination.
Dickinson JE, Evans SF.
Department of Obstetrics and Gynaecology, University of Western Australia, Perth, Australia.
OBJECTIVE: The purpose of this study was to compare the clinical efficacy and side effects of 3 doses of intravaginal misoprostol for second-trimester pregnancy termination. STUDY DESIGN: This was a prospective randomized, double-blind controlled clinical trial of 150 women who underwent pregnancy termination between 14 and 30 weeks of gestation. Three intravaginal misoprostol regimens were compared: 200 microg misoprostol at 6-hour intervals (group 1), 400 microg misoprostol at 6-hour intervals (group 2), and a loading dose of 600 microg misoprostol followed by 200 microg at 6-hour intervals (group 3). RESULTS: There was a significant difference in the median time to achieve delivery among the 3 groups: group 1 (18.2 hours [IQ, 13.3-32.5 hours]) vs group  2 (15.1 hours [IQ, 10.9-23.7 hours]) vs group 3 (13.2 hours [IQ, 11.2-21.7 hours]; P =.035). Fifty-nine percent of the women in group 1, 76% of the women in group 2, and 80% of the women in group 3 delivered within 24 hours (P =.013). There were 7.8% of the women in group 1, 0% of the women in group 2, and 2% of the women in group 3 who were undelivered at 48 hours (P =.02). There was an increase in the incidence of fever in the first 12 hours (P =.038) and in the incidence of vomiting within 3 hours of the initial dose (P =.048) in group 3 compared with the other groups. CONCLUSION: Intravaginal misoprostol 400 microg at 6-hour intervals appears to be the preferred regimen for second-trimester pregnancy termination, with a shorter commencement to delivery interval than the 200 microg regimen and fewer maternal side-effects than the 600 microg loading dose regimen.
Publication Types:
Clinical Trial

8: Clin Obstet Gynecol  2002 Mar;45(1):114-24
Cervical ripening agents and uterine stimulants.
Stitely ML, Satin AJ.
Uniformed Services University, National Naval Medical Center, Bethesda, Maryland 20814, USA. asatin@usuhs.mil
Publication Types:
Review

9: Am J Obstet Gynecol  2002 Feb;186(2):229-33
Buccal versus intravaginal misoprostol administration for cervical ripening.
Carlan SJ, Blust D, O'Brien WF.
Department of Obstetrics and Gynecology, Arnold Palmer Hospital for Children and Women, Orlando, FL, USA. scarlan@orhs.org
OBJECTIVE: The purpose of this study was to compare the efficacy of misoprostol that is administered in the buccal pouch with the intravaginal route of administration. STUDY DESIGN: One hundred fifty-seven pregnant women with a singleton live gestation, Bishop score of <7, estimated fetal weight of <4500 g, and gestational age of >24 weeks were randomized to receive misoprostol that would be placed either in the buccal pouch or vagina every 6 hours. In the buccal group, after the first 2 doses of 200 microg, the dose was increased to 300 microg for the duration of the study (up to a total of 1600 microg). In the vaginal group, after the first 2 doses of 50 microg, the dose was increased to 100 microg for the duration of the study (up to a total of 500 microg). The primary outcome variable was the interval from the first dose to vaginal delivery. Power calculations indicated the need to enroll 71 patients in each arm of the study, which would allow for the detection of a 4-hour reduction in vaginal birth interval for buccal misoprostol. RESULTS: The hours from drug administration to vaginal delivery were similar between the buccal and vaginal groups (23.5 +/- 20.8 hours versus 21.3 +/- 13.4 hours), respectively. Thirty-five women (63%) versus 34 women (67%) delivered vaginally within 24 hours (P = not significant). The incidence of tachysystole was higher in the buccal group, 28 occurrences (38%) versus 15 occurrences (19%; P =.01). CONCLUSION: Buccal misoprostol is effective for cervical ripening but results in a higher incidence of tachysystole than does intravaginal administration.
Publication Types:
Clinical Trial

10: Obstet Gynecol  2002 Feb;99(2):316-32
Misoprostol for women's health: a review.
Blanchard K, Clark S, Winikoff B, Gaines G, Kabani G, Shannon C.
Population Council, Johannesburg, South Africa. kblanchard@pcjoburg.org.za
OBJECTIVE: To review published literature on misoprostol for women's health indications to provide a synthesis of available information and highlight areas in need of additional research. DATA SOURCES: Studies were identified through searches of medical literature databases including MEDLINE, Cochrane Database, and Popline, in addition to a review of references from identified articles. STUDY SELECTION: We included all studies reported in English and published before March 31, 2001, which evaluated the efficacy of misoprostol alone for labor and delivery, evacuation of the uterus after pregnancy failure and induced abortion. Studies were not excluded based on quality or sample size. TABULATION, INTEGRATION, AND RESULTS: Misoprostol shows promise for all of the women's health indications addressed. Currently available data, though, are often hard to interpret because of variations in regimen, dose, and outcome measures. The low cost, ease of administration and storage, and widespread availability of misoprostol make it particularly appealing for developing countries. Because many of the women's health problems for which misoprostol could be prescribed currently cause significant mortality and morbidity, increased access to and information on use of misoprostol could help improve women's health especially where these problems are most severe. CONCLUSION: Further research is needed to identify optimal regimens for misoprostol for obstetric and gynecologic health indications. Registering misoprostol with national drug regulatory authorities for any of several women's health indications could help increase access to and safe use of this drug. Provider training would be a logical subsequent step.
Publication Types:
Review

11: Am J Obstet Gynecol  2002 Jan;186(1):72-6
Sublingual misoprostol for the induction of labor at term.
Shetty A, Danielian P, Templeton A.
Department of Obstetrics and Gynecology, Aberdeen Maternity Hospital, Foresterhill, Scotland.
OBJECTIVE: To evaluate the efficacy, safety, and patient acceptability of sublingual misoprostol compared with an equivalent dose administered orally for labor induction at term. STUDY DESIGN: One hundred women with medical or obstetric indications for induction of labor after 37 weeks of gestation and unfavorable cervices were randomized to receive 50 microg of misoprostol either orally or sublingually. The dose was repeated every 4 hours to a maximum of 5 doses if indicated. Previous cesarean delivery was a criteria for exclusion. Our primary outcome measure was the number of patients who went on to have a vaginal delivery within 24 hours of the induction. The need for oxytocin, mode of delivery, number of cesarean deliveries for fetal distress, uterine hyperstimulation rates, and neonatal outcomes were secondary outcome measures. Patient acceptability was assessed by questionnaires completed after delivery. RESULTS: Significantly more patients were delivered of infants within 24 hours (73.8% versus 45.7%; relative risk, 1.6; 95% confidence interval, 1.1 to 2.4) and the induction to delivery intervals were significantly shorter (20 hours versus 28.3 hours; mean difference, 8.3 hours; 95% confidence interval, 1.2 to 15.4) in the sublingual group compared with the oral group. There was 1 case of uterine hyperstimulation in the sublingual group. There were no significant differences in the mode of delivery, interventions for fetal distress, or neonatal outcomes in the 2 groups. The satisfaction rates were 82.5% and 85.7% in the oral and sublingual groups respectively, and 9.5% of patients thought that the sublingual tablets did not dissolve completely. CONCLUSION: There has been no previous report in the literature of misoprostol given sublingually for labor induction. Sublingual misoprostol seems to have better efficacy than oral misoprostol, seems to be acceptable to patients, and is an option to be considered to induce labor at term.
Publication Types:
Clinical Trial

12: Curr Opin Obstet Gynecol  2001 Dec;13(6):577-81
Induction of labour with misoprostol.
Hofmeyr GJ.
East London Hospital Complex, East London 5200, South Africa. gih@global.co.za
Misoprostol, an orally active prostaglandin E1 analogue, has been used widely by the vaginal and oral routes for labour induction at or near term. Several recent trials have confirmed that it is highly effective. Overall caesarean section rates appear to be reduced, despite a relative increase in caesarean sections for fetal heart rate abnormalities. Concern remains regarding increased rates of uterine hyperstimulation and meconium-stained amniotic fluid, although data on perinatal outcomes have been reassuring. Recent reports reviewed here have raised the possibility that postpartum haemorrhage may be increased after the induction of labour with misoprostol, and isolated reports of uterine rupture with or without previous caesarean section, continue to appear. Using small dosages appears to reduce adverse outcomes. Very large trials are needed to evaluate rare adverse outcomes.
Publication Types:
Review

13: South Med J 2000 Sep;93(9):881-4 [Texto completo en formato PDF]
Use of misoprostol for cervical ripening.
Katz VL, Farmer RM, Dean CA, Carpenter ME. Sacred Heart Medical Center, Eugene, Ore, USA.
BACKGROUND: Misoprostol, the prostaglandin E1 analog, is increasingly used for cervical ripening and induction of labor. We evaluated our experience with misoprostol in an open-label setting. METHODS: Patients were selected for cervical ripening based on clinical profile. At 3 cm cervical dilation, misoprostol was discontinued and other means of labor augmentation were used. Over 13 months, 470 inductions of labor occurred, and 455 charts were available; 254 patients (56%) received misoprostol for cervical ripening, and 144 (32%) received dinoprostone (prostaglandin E2). RESULTS: With misoprostol, mean time from beginning of contractions until delivery was 7 hours, 30 minutes; vaginal birth occurred in 85% of cases, and spontaneous labor occurred in 38%. Hyperstimulation occurred in 4 cases (1.6%) and precipitate labor in 7 (3%). All infants were discharged in excellent condition; one had a 5-minute Apgar score <7, and 33 (13%) had meconium, none with aspiration. Twenty-three patients who had had a previous cesarean section received misoprostol and delivered vaginally. CONCLUSION: Misoprostol was found to be a safe and effective agent for cervical ripening as part of labor induction.

14: South Med J 1998 Mar;91(3):248-52 [Texto completo en formato PDF]
Bishop score: a poor diagnostic test to predict failed induction versus vaginal delivery.
Hendrix NW, Chauhan SP, Morrison JC, Magann EF, Martin JN Jr, Devoe LD.
Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta 30912-3350, USA.
BACKGROUND: We evaluated the accuracy of the Bishop score in predicting the likelihood of successful labor induction (entry into active phase) in nulliparous and multiparous women. METHODS: During an index year, all patients having induction of labor and a preinduction Bishop score were included in a standard protocol for cervical ripening and use of oxytocin. Receiver-operating characteristic (ROC) curves were constructed for Bishop scores (0 to 11) to predict abdominal delivery for failed induction (final cervical dilation <4 cm) versus vaginal delivery. RESULTS: Parturients who had vaginal delivery (n = 253) and those in whom attempted induction failed (n = 38) did not differ significantly with respect to maternal demographics, length of gestation, Bishop score and its distribution, and infant birth weight. The area under the ROC curve did not differ significantly from the area under the nondiagnostic line. CONCLUSION: The Bishop score appears to be a poor predictor of the outcome of labor induction.