A randomized controlled trial of vaginal misoprostol for cervical priming before hysteroscopy.

OBJECTIVE: To evaluate the effectiveness and side effects of vaginal misoprostol for cervical dilation in nonpregnant women before hysteroscopy. METHODS: Ninety-one women scheduled to have hysteroscopy were randomized to receive either vaginal misoprostol or placebo. Cervical response, outcome of hysteroscopy, and side effects of vaginal misoprostol were assessed. RESULTS: The mean cervical dilatation estimated by Hegar dilator and the mean duration of hysteroscopy were significantly different between the treated group (7.0+/-1.0 mm [range 6-8.5] and 90.0+/-38.4 seconds [range 60-240], respectively) and the control group (3.8+/-1.2 mm [range 2-5.5] and 142.0+/-38.7 seconds [range 60-270]). In the misoprostol group, only three women (6.5%) needed cervical dilation before hysteroscopy, compared with 14 (31.1%) in the placebo group (P = .006). Cervical tears during hysteroscopy occurred in two patients (4.4%) in the control group and none in the misoprostol group. The two most common side effects of vaginal misoprostol were mild lower abdominal pain in 15 women (32.6%) and slight vaginal bleeding in 12 (26.1%). Both side effects were significantly different when compared with placebo (P<.001). CONCLUSION: Vaginal misoprostol lessens the cervical resistance in women undergoing hysteroscopy and facilitates the procedure, with only mild side effects.     

Vaginal misoprostol for cervical priming before hysteroscopy in perimenopausal and postmenopausal women.

OBJECTIVE: To evaluate the effectiveness and possible adverse effects of vaginal misoprostol for cervical priming before hysteroscopy in perimenopausal and postmenopausal women. METHODS: A total of 105 women scheduled for hysteroscopy were randomly assigned to 2 groups. The study group (n=51) received 400 microg of vaginal misoprostol at least 12 h before the procedure and the control group (n=54) received no cervical priming agent. The primary outcome measure was the number of women who required cervical dilation. Secondary outcomes were cervical width (the largest size of Hegar dilator inserted without resistance) as well as complications and adverse effects. RESULTS: In the misoprostol group 27 women (52.9%) required cervical dilation vs. 53 (98.1%) in the control group (P<0.0001). The largest size of Hegar dilator inserted without resistance was 7.6+/-1.4 mm in the misoprostol group vs. 5.0+/-1.1 mm in the control group (P<0.0001). A similar effect of misoprostol on cervical dilation was also found in the subgroup of treated postmenopausal women. Only 2 women (3.9%) experienced mild lower abdominal pain after misoprostol application. CONCLUSION: Vaginal misoprostol applied before hysteroscopy reduced cervical resistance and the need for cervical dilation in perimenopausal and postmenopausal women, with only mild adverse effects.     

A randomized trial of sublingual misoprostol for cervical priming before hysteroscopy

STUDY OBJECTIVE: To evaluate the effects of sublingual misoprostol on cervical dilatation before hysteroscopy. DESIGN: Prospective randomized study (Canadian Task Force classification I). SETTING: University teaching center. PATIENTS: Forty nulliparous women who received injection of leuprolide acetate 4 weeks before hysteroscopy, of whom 20 were randomized to treatment with misoprostol and 20 to placebo. INTERVENTION: Sublingual misoprostol 100 mug or placebo administered 12 hours before operative hysteroscopy. MEASUREMENTS AND MAIN RESULTS: Misoprostol was associated with mild abdominal cramps in four women (20%) and vaginal bleeding in another. No side effects were reported among women in the placebo group. There was no difference in baseline diameter of the cervical opening between the misoprostol group (4.0 +/- 0.1 mm) and the control group (4.2 +/- 0.2 mm). Time to dilate cervix up to 9 mm was also not significantly different (misoprostol 48.4 +/- 9.2 sec, placebo 37.7 +/- 4.1 sec). We found no difference in degree of difficulty dilating the cervix between groups. Cervical tear occurred in one patient in the misoprostol group. CONCLUSION: Sublingual misoprostol 100 mug does not facilitate cervical dilatation before hysteroscopy. This may be related to leuprolide's hypoestrogenic effect.     

Efficacy of vaginal misoprostol before hysteroscopy for cervical priming in patients who have undergone cesarean section and no vaginal deliveries

We wanted to investigate the effect of misoprostol administered vaginally before operative hysteroscopy on cervical dilation, complications, and failure rates in patients who have undergone cesarean section and who have never delivered vaginally. Sixty patients who had undergone cesarean section, who had never delivered vaginally before, and were about to undergo hysteroscopy for various intrauterine lesions were included in this randomized controlled study. Thirty-two patients in the study group were given misoprostol 400 microg, and 28 patients in the control group were given placebo (hexetidine pill) vaginally twice, 6 and 12 hours before the procedure. Primary endpoints were cervical width detected with Hegar dilators and complication and failure rates. Mean cervical width was greater in patients in the study group (6.5 +/- 0.8) than it was in patients in the control group (3.0 +/- 0.6), (p = .0001). Complication and failure rates were lower in patients in the study group (p = .01). Administration of vaginal misoprostol before hysteroscopy proved to be effective in cervical ripening and in reducing complication and failure rates.     

Vaginal misoprostol for cervical priming before dilatation and curettage in postmenopausal women: a randomized controlled trial

AIM: To investigate the efficacy of vaginal misoprostol for cervical priming before dilatation and curettage in postmenopausal women. METHODS: Forty-four postmenopausal women with indication for dilatation and curettage were randomly assigned to receive either 400 micro g of misoprostol or placebo vaginally 6 h before dilatation and curettage. The main outcome measures were the number of women who required cervical dilatation, cervical width, time taken to dilate to Hegar 6 and other complications. RESULTS: The mean cervical diameter (4.59 millimeters in the misoprostol group vs 4.41 millimeters in the placebo group) was comparable between the two groups. A similar number of women in the misoprostol group and in the placebo group required cervical dilatation (12 vs 16, P = 0.35). The operative times for both groups were similar. The incidence of side-effects was comparable in both groups. There were two uterine perforations in the misoprostol group (2 vs 0). CONCLUSION: There was no significant benefit from applying 400 micro g vaginal misoprostol 6 h prior to dilatation and curettage in postmenopausal women.     

The use of oral misoprostol as a cervical ripening agent in operative hysteroscopy: a double-blind,placebo-controlled trial

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.     

A combination of misoprostol and estradiol for preoperative cervical ripening in postmenopausal women: a randomised controlled trial

Objective  To compare the impact of 1000 μg of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after 2 weeks of pretreatment with estradiol vaginal tablets in postmenopausal women prior to day-care operative hysteroscopy.
Design  Randomised, double-blind, placebo-controlled sequential trial.
Setting  Norwegian university teaching hospital.
Population  Sixty-seven postmenopausal women referred for day-care operative hysteroscopy.
Methods  The women were randomised to receive either 1000 μg of self-administered vaginal misoprostol or self-administered vaginal placebo on the evening before day-care operative hysteroscopy. All women had administered a 25-μg vaginal estradiol tablet daily for 14 days prior to the operation.
Main outcome measures  Primary outcome: preoperative cervical dilatation at hysteroscopy. Secondary outcomes: difference in dilatation at recruitment and before hysteroscopy, number of women who achieved a preoperative cervical dilatation of 5 mm or more, acceptability, complications and adverse effects.
Results  The mean cervical dilatation was 5.7 mm (SD, 1.6 mm) in the misoprostol group and 4.7 mm (SD, 1.5 mm) in the placebo group, the mean difference in cervical dilatation being 1.0 mm (95% CI, 0.2–1.7 mm). Self-administered vaginal misoprostol of 1000 μg at home on the evening before day-care hysteroscopy is safe and highly acceptable, although a small proportion of women experienced lower abdominal pain.
Conclusions  One thousand micrograms of self-administered vaginal misoprostol, 12 hours prior to day-care hysteroscopy, after 14 days of pretreatment with vaginal estradiol, has a significant cervical ripening effect compared with placebo in postmenopausal women.     

Prostaglandins prior to hysteroscopy

This prospective randomized controlled study was conducted to assess the role of misoprostol, given sublingually or rectally, on the outcome of hysteroscopic procedures. A total of 212 premenopausal patients undergoing hysteroscopic procedures were randomly allocated into three groups: group 1 (n = 71), sublingual misoprostal given 2 h before the procedure; group 2 (n = 71) rectal misoprostal 2 h before the procedure; group 3 (n = 70), control group, no medications were given. Main outcome measures were ease of cervical dilatation, dilatation time to Hegar 6, complications as cervical laceration and postoperative cramps, bleeding and pyrexia. The cervical canal at the start was significantly wider misoprostol groups (P = 0.038). Cervical dilatation was significantly easier in the rectal misoprostol group over control (P = 0.035). Misoprostol groups showed significant reduction in the mean time needed to dilate to Hegar 6 (P = 0.021). Postoperative pain and cramps were significantly higher in misoprostol groups (P = 0.002). Misoprostol before hysteroscopy demonstrates a benefit in the ease of cervical dilatation, cervical width at the start and time for dilatation with low risk of cervical tears. Rectal misoprostol appears advantageous than sublingual one. However, postoperative adverse effects are more common with misoprostol groups.     

A prospective, randomized, controlled trial comparing vaginal misoprostol and osmotic dilator in achieving cervical ripening before operative hysteroscopy

The purpose of this study was to compare the effectiveness of vaginal misoprostol and an osmotic dilator in achieving cervical ripening before operative hysteroscopy in pre-menopausal women. One hundred patients undergoing operative hysteroscopies with a 9-mm hysteroscope were prospectively and randomly assigned to two groups. In group 1 (the misoprostol group), 53 patients received 400 μg of vaginal misoprostol 12 h before the operation. In group 2 (the osmotic dilator group), 47 patients had an osmotic dilator inserted into the cervical canal 12 h before the operation. The primary outcome measure in this study was cervical width, assessed by the largest number of Hegar dilators that could be inserted into the cervix without resistance. The secondary outcome measure was the subjective assessments of the ease of dilatation to 9 mm by the surgeon. Adverse effects experienced including preoperative pain and vaginal bleeding were recorded for each group. There was no difference between the two groups with regard to demographic variables. The spontaneous cervical dilatation (mean ± SD) in the osmotic dilator group (9.6±2.2 cm) was significantly (P<0.01) greater than that in the misoprostol group (8.0±1.8 cm). In addition, the proportion of difficult dilatation in the osmotic dilator group (8 out of 47, 17.0%) was significantly less than that in the misoprostol group (22 out of 53, 41.5%). The occurrence of vaginal bleeding in the misoprostol group (77.4%) was significantly (P<0.01) higher than that in the osmotic dilator group (31.9%). The osmotic dilator is more effective than misoprostol at achieving cervix ripening prior to operative hysteroscopy.     

Sublingual versus vaginal misoprostol for cervical ripening before hysteroscopy: a randomized clinical trial

Purpose

To evaluate the efficacy of two routes of misoprostol (sublingual and vaginal) for cervical ripening before hysteroscopy.

Methods

One hundred and ten perimenopausal women who were referred to a tertiary hospital for surgical hysteroscopy enrolled in this double-blind randomized clinical trial. They were divided into two groups to receive 400 mg misoprostol either sublingually or vaginally 6 h before hysteroscopy. The duration of dilatation, Hegar number inserted into the cervix without resistance, and hysteroscopic and drug complications were recorded for all cases.

Results

Forty-nine women in sublingual and 51 in vaginal group participated in the study. Dilatation time was significantly lower in sublingual group (P < 0.001). Median Hegar number passed into the cervix without resistance was 5 in sublingual versus 4 in vaginal group (P = 0.002). Cramp followed by vomiting and diarrhea were the most common side effects of misoprostol in the sublingual group, while cramp followed by vomiting was the most frequent side effect in the vaginal group. Diarrhea was not reported in the vaginal group (P = 0.008).

Conclusion

Sublingual route of misoprostol could be considered as an effective medication before surgical hysteroscopy in perimenopausal women.     

A systematic review and meta-analysis of randomized studies comparing misoprostol versus placebo for cervical ripening prior to hysteroscopy

Objective(s): Hysteroscopy is an effective method for examining the uterine cavity but has some limitations, including the occasional need for cervical dilatation. Misoprostol is routinely used for cervical dilatation in various procedures but has not gained wide acceptance for use before hysteroscopy. Study design: This review includes randomized controlled trials which compare the use of misoprostol versus placebo by different routes and doses before diagnostic or operative hysteroscopy. The MEDLINE database and the Cochrane Central Register of Controlled Trials were searched for articles published from January 1970 to April 2010. The outcome measures studied were related either to the facilitation of the hysteroscopic procedure (need for cervical dilatation, cervical width at the beginning of hysteroscopy, duration of the procedure and complications such as cervical tear and uterine perforation) or to the medication side-effects. With regard to side-effects, we studied the incidence of nausea, diarrhea, abdominal pain, bleeding, and fever. Results: Vaginal misoprostol reduced the need for cervical dilatation in the total population of pre- and post-menopausal women to a statistically significant degree. In the subgroup of operative hysteroscopy the need for dilatation and the duration of the procedure were also significantly reduced. Most other outcomes relating to the facilitation of the procedure did not reach statistical significance. The side effects in the misoprostol group were significantly more frequent than in the placebo group. Conclusion(s): There is insufficient evidence to recommend the routine use of misoprostol before every hysteroscopy. As the lack of serious benefit from misoprostol is unlikely to be due to type II error, its use should be reserved for selected cases.     

A randomised placebo-controlled trial of vaginal misoprostol for cervical priming before hysteroscopy in postmenopausal women

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.     

Laminaria Tent vs Misoprostol for Cervical Priming before Hysteroscopy: Randomized Study

Study ObjectiveTo compare the efficacy of laminaria tents and orally administered misoprostol in priming the cervix before operative hysteroscopy.DesignRandomized, controlled study (Canadian Task Force classification I).SettingTertiary medical center.PatientsOne hundred twenty premenopausal women who underwent operative hysteroscopy between March 2005 and January 2007.InterventionThe women were randomized to receive a laminaria tent or misoprostol for cervical priming.Measurements and Main ResultsThe primary outcomes were postpriming cervical width insofar as size of Hegar dilators and need for cervical dilation. The secondary outcomes were adverse effects from the priming methods. Postpriming cervical width was greater in the laminaria group but not significantly different from that in the misoprostol group. However, cervical dilation before hysteroscopy was required in more patients in the misoprostol group. Nausea, vomiting, diarrhea, and bleeding were more common in the misoprostol group, and the incidences of chills and headache were similar between the 2 groups.ConclusionLaminaria tents are superior to oral misoprostol insofar as less need for cervical dilation and fewer adverse effects.     

Cervical ripening using misoprostol before hysteroscopy

Cervical ripening with misoprostol is performed before office or operative hysteroscopy. Aim of this review is to evaluate benefits of cervical ripening with misoprostol before hysteroscopy .Ten studies were selected concerning office or operative hysteroscopy. Cervical ripening with misoprostol seems to be not useful for office hysteroscopy performed with minihysteroscope. Interest of misoprostol in menopausal women with traditional office hysteroscope is debatable. Risk of cervical tear during operative hysteroscopy seems to be reducing with misoprostol. However, interest of misoprostol was not found in all studies. Data were not sufficient to determine adequate dose of misoprostol, time and mode of administration. However, vaginal administration is preferable.     

Cervical ripening prior to hysteroscopy: is the application of misoprostol useful?

Cervical dilatation has to be considered a fundamental step in operative hysteroscopy. Different methods are used to facilitate cervical dilatation. The aim of this review is to evaluate the efficacy of Misoprostol in cervical ripening prior to operative hysteroscopy through the evaluation of published studies. Initially designed for the treatment of peptic ulcers caused by non-steroidal anti-inflammatory drugs, misoprostol, a prostaglandin E1 analogue, is commonly used for medical abortion in the first and second trimesters, cervical priming before vacuum aspiration or dilation and curettage, induction of labor, and the prevention and treatment of postpartum hemorrhage. Misoprostol was licensed for oral administration, but a large number of clinical studies have reported that vaginal administration is more effective in cervical ripening. Misoprostol is effective in inducing an adequate cervical dilatation prior to an operative hysteroscopy. Vaginal administration could be necessary for all conditions where cervical ripening is difficult to perform. Patients given GnRH analogue therapy before hysteroscopy may benefit from the application of Misoprostol. However, its use in postmenopausal patients may not be efficacious. As far as the application of Misoprostol prior to diagnostic hysteroscopy is concerned, the number of patients that may find an advantage in the treatment is probably very small. Misoprostol has some important advantages, such as easy application, very low price, and greater acceptability by doctors and patients.     

A randomized controlled trial for cervical priming using vaginal misoprostol prior to hysteroscopy in women who have only undergone cesarean section

Purpose

To evaluate the efficacy of misoprostol administrated vaginally on cervical priming and its complications prior to diagnostic or operative hysteroscopy in women who have undergone at least one cesarean section and who have never delivered vaginally before and/or had other transcervical procedure.

Methods

A total of 55 patients undergoing hysteroscopy for various intra-uterine lesions were included in this study and were randomly allocated to two groups finally. Thirty patients in the study group were given 200?μg misoprostol vaginally 12?h before the procedure, whereas 25 patients in the control group did not receive any cervical priming. The countered outcome included the cervical width detected with Hegar dilatators and complication rates.

Results

Mean cervical width was greater in the study group (6.6?±?1.3) than in the control group (5.1?±?0.9). Complications and failure rates were lower in the study group.

Conclusion

Application of 200?μg misoprostol vaginally 12?h before hysteroscopy softens the cervix, reduces cervical resistance and consequently the need for cervical dilatation, with only mild side effects.     

A randomised comparison between sublingual, oral and vaginal route of misoprostol for pre-abortion cervical ripening in first-trimester pregnancy termination under local anaesthesia

OBJECTIVE: To compare efficacy of sublingual (S/L), oral and vaginal routes of misoprostol administration for cervical priming before suction evacuation (SE) under local anaesthesia. METHODS: In a prospective randomised clinical trial, 200 women in the first trimester of pregnancy were randomised into four groups of 50 each. Patients in control group did not receive any medication before SE while other treatment groups received 400 microg of misoprostol three hours prior to SE either by sublingual/oral or by vaginal route. Main outcome measure was basal cervical dilatation while the secondary outcome measures were operative blood loss, time duration of surgery, patient satisfaction, pain perception and adverse effects. RESULTS: Sublingual group had a higher dilatation (9.9 +/- 2.1 mm; P < 0.001) and lower time duration of surgery (3.6 +/- 1.0 min; P < 0.01) as compared to oral (8.2 +/- 2.6 mm, 4.9 +/- 1.7 min) or vaginal routes (7.6 +/- 2.6 mm, 5.2 +/- 1.8 min). Mean pain score of the sublingual group was significantly lower (2.4 + 1.3; P < 0.001) as compared to oral (3.4 +/- 1.3) or vaginal routes (3.6 +/- 1.2). Patient acceptability was higher for sublingual (53 of 150) and oral routes (62 of 150) as compared to vaginal (35 of 150) route. CONCLUSION: Sublingual route was significantly more effective than oral or vaginal administration of misoprostol for cervical dilatation. To the best of our knowledge, this is the first study to simultaneously compare the efficacy of sublingual, oral and vaginal routes of misoprostol for cervical priming before SE.     

A comparison of orally administered misoprostol with vaginally administered misoprostol for cervical ripening and labor induction.

OBJECTIVE: Our purpose was to compare orally administered with vaginally administered misoprostol for cervical ripening and labor induction. MATERIAL AND METHODS: Two hundred twenty subjects with medical or obstetric indications for labor induction and undilated, uneffaced cervices were randomly assigned to receive orally administered or vaginally administered misoprostol. Fifty micrograms of oral misoprostol or 25 microgram of vaginal misoprostol was given every 4 hours. If cervical ripening (Bishop score of >/=8 or cervical dilatation of >/=3) or active labor did not occur, repeated doses were given to a maximum of 6 doses or 24 hours. Thereafter, oxytocin was administered intravenously by a standardized incremental infusion protocol to a maximum of 22 mU/min. RESULTS: Of the 220 subjects evaluated, 110 received orally administered misoprostol and 110 received vaginally administered misoprostol. Fewer subjects who received the oral preparation (34/110, 30.9%) were delivered vaginally within 24 hours of initiation of induction, in comparison with those who received the vaginal preparation (52/110, 47.3%) (P =.01). The average interval from start of induction to vaginal delivery was nearly 6 hours longer in the oral treatment group (mean and SD 1737.9 +/- 845.7 minutes) than in the vaginal treatment group (mean and SD 1393.2 +/- 767.9) (P =.005, log-transformed data). Orally treated patients required significantly more doses than vaginally treated patients (orally administered doses: mean and SD 3.3 +/- 1.7; vaginally administered doses: mean and SD 2.3 +/- 1.2) (P <.0001). Oxytocin administration was necessary in 83 (75.4%) of 110 orally treated subjects and in 65 (59.1%) of 110 vaginally treated subjects (P =.01, relative risk 1. 28, 95% confidence interval 1.06-1.54). Vaginal delivery occurred in 95 (86.4%) orally treated subjects and in 85 (77.3%) vaginally treated subjects (P =.08, relative risk 1.12, 95% confidence interval 0.99-1.27), with the remainder undergoing cesarean delivery. There was no difference in the incidence of uterine contractile abnormalities (tachysystole, hypertonus, or hyperstimulation), intrapartum complications, or neonatal outcomes between the 2 groups. CONCLUSIONS: Oral administration of 50-microgram doses of misoprostol appears less effective than vaginal administration of 25-microgram doses of misoprostol for cervical ripening and labor induction. Further investigation is needed to determine whether orally administered misoprostol should be used for cervical ripening and labor induction.     

The effect of oral versus vaginal misoprostol on cervical dilatation in first-trimester abortion: a double-blind, randomized study.

OBJECTIVES: To determine the effect of oral versus vaginal misoprostol on cervical dilatation in first-trimester intrauterine evacuation or menstrual regulation (MR). DESIGN AND METHODS: A total of 120 patients were randomly assigned to a double-blind prestudy. Four groups, each consisting of 30 cases, were administered one of four regimens: 200 microg misoprostol orally, 200 microg misoprostol intravaginally, placebo orally, or placebo intravaginally, 10 h before MR, respectively. Age, number of births and abortions, birth methods, date of last delivery and last abortion were recorded. The gestational age was determined by ultrasonography. Prior to MR, data regarding the time of the application of the drug, the presence of placenta in the cervical canal, the degree of cervical dilatation, the duration of MR and patients' complaints were recorded. The MRs were performed by the same physician. The statistical analyses were evaluated with the chi(2) test and Fisher's exact test in the Aegean University Science Faculty Department of Statistics. RESULTS: In the oral misoprostol group, four patients had cervical bleeding and one had intracervical placenta. In the intravaginal misoprostol group, cervical bleeding was observed in seven patients and intracervical placenta was recorded in four cases. Cervical bleeding was observed in one case and intracervical placenta was also observed in one case in the oral placebo group. Cervical dilatation reached 8 mm in seven patients in the oral misoprostol group and in three patients in the intravaginal group, with none in the placebo group. Symptoms such as pelvic pain, headache and nausea were observed in 11 cases in the oral and 14 cases in the vaginal misoprostol groups. CONCLUSIONS: Different methods of misoprostol administration may not be equivalent in terms of efficacy and side-effects. Therefore, we decided to extend the study to include more patients so as to achieve statistically significant results.     

Use of misoprostol prior to hysteroscopy in postmenopausal women: a randomized, placebo-controlled clinical trial

Study ObjectiveTo compare results of diagnostic hysteroscopy in postmenopausal women using misoprostol for cervical ripening.DesignA randomized, placebo-controlled clinical trial (Canadian Task Force classification Ib).SettingHospital Barão de Lucena, Instituto Materno Infantil de Pernambuco.PatientsOne hundred-twenty postmenopausal women.InterventionPostmenopausal women received 200 μg of vaginal misoprostol or placebo before hysteroscopy.Measurements and Main ResultsVariables measured were procedure time, frequency of hysteroscopy carried out in each group (misoprostol and placebo), degree of pain during procedure, need for dilation, side effects, and complications of hysteroscopy. The χ², Fisher’s exact, and Mann-Whitney tests were used and considered significant when alpha error was <5%. There were similarities between the groups in age (p = .09), body mass index (p = .55), time since menopause (p = .52), and genital bleeding (p = .52). Pain during the procedure, as measured by visual analog scale, was less severe in the misoprostol group than in the placebo group (median of 05 vs 07, p = .02), but there were similarities in duration (2.4 min vs 2.0 min, p = .3), pain during procedure and biopsy (p = .74 vs p = .19), need for dilation (p = .66), side effects, and complications. There were no differences in severity of post-procedure pain.ConclusionsPrevious use of misoprostol reduced pain severity during hysteroscopy.