Baseline Cervical Dilatation Research Articles

A randomised comparative study of sublingual and vaginal misoprostol for cervical priming before minor gynaecological procedures

This study aimed to compare the effect of misoprostol using vaginal or sublingual routes on the non-pregnant uterine cervix prior to minor gynaecological procedures. One hundred and forty women were randomised 1:1 into two groups: A and B. Group A received misoprostol 400 mcg vaginally and pyridoxine 40 mg sublingually and Group B received misoprostol 400 mcg sublingually and pyridoxine 40 mg vaginally 4 h prior to procedure. The outcomes studied were maximum size of Hegar’s dilator that could be inserted into the cervix without any resistance, ease of dilatation, need and time required for further dilatation, side effects and complications. Baseline cervical dilatation was significantly more in Group A than Group B. Need for further dilatation and time required for further dilatation were also significantly less in Group A than Group B. Thus, we conclude that vaginal misoprostol is more effective than sublingual misoprostol in cervical priming before minor gynaecological procedures. Clinical Trial Registration Number: www.ctri.nic.in; CTRI/2018/07/015080 IMPACT STATEMENT What is already known on this subject? Cervical priming has been shown to result in shorter operative time, easier mechanical dilatation, reduced incidence of complications and blood loss when used prior to surgical abortion and has been recommended as a standard practice in various national and international guidelines for safe abortion practices. Misoprostol has many advantages over other ripening agents like osmotic dilators, other prostaglandins and mifepristone. Misoprostol can be given through oral, sublingual, vaginal, buccal and rectal routes. Use of misoprostol has been found to improve cervical dilatation, reduce need of further dilatation and ease of dilatation without many complications when compared to placebo for cervical priming of non-pregnant cervix. Studies comparing vaginal and sublingual routes have shown no significant difference for cervical ripening in pregnant women. What the results of this study add? We found that vaginal misoprostol for cervical priming was more effective than sublingual misoprostol in reaching a higher baseline cervical dilatation, with reduced need and time required for further dilatation before minor gynaecological procedures, although the ease of dilatation was similar in both groups. This effect of vaginal misoprostol was more marked in premenopausal women. What the implications are of these findings for clinical practice and/or further research? The results of our study are at variance with other studies done on use of misoprostol via the vaginal or sublingual routes, and hence it is imperative that large multi-center studies be performed to bring about consensus on the topic.

Ideal Time of Vaginal Misoprostol Administration in nulliparous women undergoing Office Hysteroscopy: a randomized double blind placebo controlled study

Background: hysteroscopy is the process of viewing and operating in the endometrial cavity from a transcervical approach. It is the gold standard procedure for uterine cavity exploration. Objective: to detect ideal time of vaginal misoprostol administration for cervical priming in nulliparous women prior to office hysteroscopy by comparing between giving 400 microgram 3 hours, 6 hours and 12 hours before office hysteroscopy. Patients and Methods: randomized double-blind placebo-controlled study. This study was done on 198 patients to whom office hysteroscopy was done as a part of investigation of (infertility,recurrent miscarriage or abnormal uterine bleeding). Result: in group A which received 400μgm vaginal misoprostol 12 hours before office hysteroscopy, pain score was lower compared to group B compared to group C . Procedural time was shorter in group A compared to group B compared to group C , cervical entry was easier in group A compared to group B compared to group C , baseline cervical dilatation was greater in group A compared to group B compared to group C vaginal bleeding was least in group A compared to group B compared to group C . Conclusion: use of 400μgm vaginal misoprostol 12 hours before hysteroscopy is better than using it 6 hours and 3 hours in facilitating cervical ripening with minimal side effects without use of anasthesia.as it decrease pain score, decrease procedure duration, increase ease of cervical entry, higher patient acceptability and with minimal side effects

Intramuscular Pethidine for Pain Relief in the First Stage of Labor

Objective: The objective of this study was to see the efficacy of intramuscular pethidine for pain relief in the 1st stage of labor.
 Methods: This prospective study was carried out in the Department of Obstetrics & Gynaecology, Dhaka Medical College Hospital, Dhaka from April 2005 to December 2005. Age and parity matched 80 pregnant women were recruited in the study and were divided equally in experimental and palcebo groups (40 in each group). The Experimental group received intramuscular Inj. Pethidine HCI 1.5 mg/kg body weight in 2 ml with Inj. metoclopramide 12.5 mg and the Placebo group received 2 ml intramuscular normal saline. The intervention was started at active first stage of labor with cervical dilatation of 3-4 cm and when patients requested for analgesia. Pain was assessed at the highest point of pain at 15- and 30-minute intervals using 100 mm visual analogue scale (VAS) and patients were asked to give a verbal categorical rating of their pain as "a lot better", "a little better", "much the same", "a little worse", or "much worse". Level of sedation was also assessed at the same intervals. Details of labor, including cervical dilatation before and after analgesia, mode of delivery, duration of injection to delivery time and assessment of neonates by APGAR score at one and five minutes were recorded.
 Result: All the baseline characteristics like maternal age, body surface area (BSA), parity, gestational age of the subjects between the Experimental and Placebo groups were almost identical. All the intrapartum variables like baseline cervical dilatation, VAS pain score, VAS sedation score and injection to delivery interval were also found to be fairly comparable between groups. At 15 minutes interval more than one-quarter (27.5%) of the Experimental group got mildly drowsy, while none of the Placebo group changed from their baseline status. At 30 minutes interval 27.5% were mildly drowsy, 22.5% were moderately drowsy and 1 (2.5%) was asleep in the Experimental group, while all of the Placebo group subjects were alert as before. The groups were quite different in respect to level of sedation following intervention (p < 0.001). Nearly three quarters (72.5%) of the Experimental group had VAS pain score at 30 minutes interval at or below median level, whereas only 25% of the Placebo group had the same level at same interval (p < 0.001). The Experimental group had a significantly lower demand for further analgesia (50%) compared to the Placebo group (80%) (p=0.005). However, 15 (37.5%) subjects of the Experimental group experienced nausea and or vomiting, whereas none of the Placebo group had such experience (p<0.001). Majority (82.5%) of the Experimental group and 75% of the Placebo group had normal delivery. The comparison of foetal outcome in terms of APGAR score at 1 and 5 minutes, oxygen needed and NICU admission required for resuscitation revealed no significant difference between the groups with respect to any of these variables (p<0.05).
 Conclusion: The intramuscular Pethidine is significantly effective at providing analgesia in pregnant women in 1st stage of labor. The findings support the continued use of pethidine as a simple and cheap therapeutic option in the management of labor pain.
 Ibrahim Card Med J 2017; 7 (1&2): 99-106

Evaluation of isosorbide-5-mononitrate as a cervical ripening agent prior to induced abortion in contrast to misoprostol- a randomized controlled trial

ObjectiveTo determine whether vaginal application of 40 mg isosorbide-5-mononitrate (ISMN) has a comparable cervical ripening efficacy to and lesser side effects than 400 µg misoprostol in women scheduled for the first trimester induced abortion using a manual vacuum aspirator (MVA).MethodsWe conducted a prospective randomized open-label study in 70 women at 6–12 weeks of pregnancy at the R G Kar Medical College and Hospital, Kolkata, India, over a period of two years from 2015 to 2017. Forty milligrams of ISMN and 400 µg misoprostol were vaginally applied for cervical priming. The primary outcome measure was the cervical response assessed by the passage of the appropriate and largest sized MVA cannula through the internal os without resistance, at the beginning of the procedure.ResultsThe base line cervical dilatation was found to be significantly higher in the misoprostol group than in the ISMN group (7.65±1.38 vs. 6.9±1.26 mm; P=0.025, 95% confidence interval, −1.4046 to −0.953). However, when the women were sub-analyzed based on parity, there was no statistically significant difference in the same parameters among the multigravid women. The need for further cervical dilatation was significantly higher in the ISMN group when the primigravid women were compared, although the multigravid women responded favorably to ISMN.ConclusionIn the primigravid women, misoprostol appears to exert a higher efficacy as a cervical ripening agent in contrast to ISMN. However, ISMN can be used in multigravid women for the same purpose as in this group, misoprostol did not show any significant improvement in efficacy over ISMN.

Comparison of intravaginal misoprostol and intramuscular carboprost for cervical priming in the first trimester of medical termination of pregnancy

Background: Suction evacuation is a widely used method for elective termination of pregnancy in the first trimester. The step of mechanical cervical dilatation during this procedure is probably the most critical step. Difficult cervical dilatation may cause incomplete evacuation, cervical laceration, and uterine perforation. Prior cervical priming with pharmacological agents like prostaglandin derivatives, although not free from side effects, makes the procedure easier with reduced overall complication rate and hence recommended in several guidelines. Aim: The aim of the study was to compare, two prostaglandin derivatives, intravaginal misoprostol (15-deoxy-16-hydroxy 16-methylprostaglandin E1) with intramuscular carboprost (15-methyl prostaglandin F2α) for cervical priming prior to suction evacuation in the first-trimester termination of pregnancy. Settings and Design: A prospective study was conducted at Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, Maharashtra. Materials and Methods: Eighty women requesting pregnancy termination from 6th to 12th week gestation were randomized into two groups. Two hours prior to suction evacuation, the first group (n = 40) received 400 μg of intravaginal misoprostol, while the second group (n = 40) received 125 μg of intramuscular injection carboprost. The outcomes of both the groups were recorded in terms of baseline cervical dilatation, immediate complications, drug-induced side effects, and patient's acceptability by questionnaire. Results: The “mean baseline cervical dilatation” prior to suction and evacuation in the misoprostol group was 8.11 ± 0.95 mm in the carboprost group was 6.25 ± 0.06 mm which is highly significant (t = 7.02, P 8 mm, compared to 17.5% in carboprost group (P = 0.004). The side effects including nausea, vomiting, and abdominal cramps were more in carboprost group as compared to the misoprostol group. No patient had diarrhea in misoprostol group as against 32.5% in carboprost group (P

Synthetic osmotic dilators with adjunctive misoprostol for same-day dilation and evacuation: a randomized controlled trial

ObjectiveThis study aims to evaluate buccal misoprostol as an adjunct to synthetic osmotic dilators for same-day dilation and evacuation (D&E). Study designA randomized, double-blinded, placebo-controlled trial of women 16 0/7 to 20 6/7 weeks gestation desiring D&E was used. Participants received synthetic osmotic cervical dilators (Dilapan-S®) at least 4 h prior to D&E and were randomized to 400mcg buccal misoprostol or placebo 3 h preoperatively, stratified by gestational age. The primary outcome was operative time with 36 participants needed to detect a 4-min difference (two-sided α=0.05, 80% power). Secondary outcomes included total procedure time, patient and provider acceptability, baseline cervical dilation and complications. ResultsTwenty-nine women were enrolled (misoprostol n=14, placebo n=15) and mean operative time was similar between the groups (11.1 vs. 13.5 min, respectively, p=.17). Complications were nonsignificantly more common for participants ≥19 weeks compared to <19 weeks (22% vs. 9%, p=.62) and those who received placebo compared to misoprostol (27% vs. 7%, p=.33). Two serious adverse events in the placebo group prompted early study closure for safety and futility. Placebo participants had longer overall procedure times (24 vs. 18 min, p=.03) and less cramping preoperatively (p<.01) but similar results for other secondary outcomes compared to those receiving misoprostol. Women strongly preferred same-day cervical preparation (98%). ConclusionsAdjunctive buccal misoprostol may not decrease operative times but may decrease complications when combined with synthetic osmotic dilators for cervical preparation for same-day D&E procedures. ImplicationsAlthough the trial was halted early and underpowered to make conclusions about the primary outcome, complication frequency and type warrant caution for use of synthetic osmotic dilators alone for cervical preparation for same-day D&E at ≥19 weeks gestation.

Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 h prior to surgical abortion: a double-blinded RCT.

Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 h prior to surgical abortion: a double-blinded RCT.

Nitric oxide donors for cervical ripening in first-trimester surgical abortion.

Cervical priming before first-trimester surgical abortion is recommended in certain groups of women. Nitric oxide (NO) donors induce cervical ripening without uterine contractions, but the efficacy and side effects are of concern. To evaluate NO donors for cervical ripening before first-trimester surgical abortion, in terms of efficacy, side effects, and reduction of complications. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and POPLINE. We also searched reference lists of retrieved papers. We contacted experts in the field for information on both published and unpublished trials. Randomised controlled trials comparing NO donors alone or in combination with other methods for cervical ripening in first-trimester surgical abortion. Two review authors independently selected and extracted the data onto a data extraction form. We processed the data using Review Manager (RevMan 5) software. We included 9 studies involving 766 participants. There were no serious complications (infection requiring antibiotic treatment, blood transfusion, complications requiring unintended operation, cervical injury, uterine perforation, death or serious morbidity) in the included trials.NO donors were more effective in cervical ripening when compared with placebo or no treatment. Baseline cervical dilatation before the procedure was higher in NO donors group (mean difference (MD) 0.30, 95% confidence interval (CI) 0.01 to 0.58) The cumulative force required to dilate the cervix to 8 mm (MD -4.29, 95% CI -9.92 to 1.35), headache (risk ratio (RR) 1.73, 95% CI 0.86 to 3.46), abdominal pain (RR 0.87, 95% CI 0.50 to 1.50), or patient satisfaction (RR 0.95, 95% CI 0.84 to 1.07) were not different. More nausea and vomiting occurred in the women who received a NO donor (RR 2.62, 95% CI 1.07 to 6.45).NO donors were inferior to prostaglandins for cervical ripening. The cumulative force required to dilate the cervix to 8 mm to 9 mm was higher (MD 13.12, 95% CI 9.72 to 16.52), and baseline cervical dilatation was less (MD -0.73, 95% CI -1.01 to -0.45) in the NO donor group. However, the probability of dilation greater than 8 mm at three hours was higher in the NO donor group (RR 6.67, 95% CI 2.21 to 20.09). Side effects including headache (RR 5.13, 95% CI 3.29 to 8.00), palpitation (RR 3.43, 95% CI 1.64 to 7.15), dizziness (RR 3.29, 95% CI 1.46 to 7.41), and intraoperative blood loss (MD 33.59 ml, 95% CI 24.50 to 42.67) were also higher. However, abdominal pain (RR 0.33, 95% CI 0.25 to 0.44) and vaginal bleeding (RR 0.14, 95% CI 0.07 to 0.27) were less in the NO donor group. No difference for nausea/vomiting in both groups(RR 1.17, 95% CI 0.94 to 1.46). Patient satisfaction was not different.One trial compared a NO donor with a NO donor plus prostaglandin. The cumulative force required to dilate the cervix to 8 mm was higher (MD 14.50, 95% CI 0.50 to 28.50) in the NO donor group. There was no difference in headache (RR 0.88, 95% CI 0.38 to 2.00), abdominal pain (RR 0.14, 95% CI 0.02 to 1.07), or intraoperative blood loss (MD -50, 95% CI -164.19 to 64.19). NO donors are superior to placebo or no treatment, but inferior to prostaglandins for first-trimester cervical ripening, and associated with more side effects.

English

BACKGROUND: Suction evacuation is widely used method for elective termination of pregnancy in first trimester. The step of mechanical cervical dilatation during this procedure is probably the most critical step. Difficult cervical dilatation may cause incomplete evacuation, cervical laceration, and uterine perforation. Prior cervical priming with pharmacological agents like prostaglandin derivatives although not free from side effects, makes the procedure easier with reduced overall complication rate, and hence recommended in several guidelines. AIM: We compared, two prostaglandin derivatives, sublingual Misoprostol (15-deoxy-16hydroxy16- methylprostaglandinE1) with intramuscular Carboprost (15-methylProstaglandinF2α.) for cervical priming prior to suction evacuation in first trimester termination of pregnancy. SETTINGS AND DESIGN: Prospective study was conducted at tertiary care institute in Mumbai. METHODS: Eighty women requesting pregnancy termination from 6 th to12 th weeks gestation were randomized in two groups. Two hours prior to suction evacuation, first group (N=40) received 400 µg of sublingual Misoprostol, while second group (N=40) received 250µg of intramuscular injection Carboprost. Outcomes of both groups were recorded in terms of baseline cervical dilatation, immediate complications, drug induced side effects and patient acceptability by questionnaire. STATISTICAL ANALYSIS: Performed by SPSS Inc, Version 15, Continuous variables were compared using ttest/ANOVA. Categorical variables were compared by Chi- Square test or Fisher exact test. Probability value 0.05).42.5% women in Misoprostol group had cervical dilatation >8mm, compared to 17.5% in Carboprost group (P-0.004). The side effects including nausea, vomiting and abdominal cramps were more in Carboprost group as compared to Misoprostol group. No patient had diarrhea in Misoprostol group as against 32.5% in Carboprost group (P<0.0001). There were no complications like in complete evacuation, cervical lacerations or uterine perforation noted in either group. CONCLUSION: Cervical priming prior to suction evacuation results in easier dilatation reducing the incidence of complications. Sublingual Misoprostol appears to be more effective with minimal side effects hence, easily acceptable alternative as compared to intramuscular Carboprost.

Role of sublingual misoprostol for cervical priming in first trimester medical termination of pregnancy.

To evaluate the efficacy and safety of sublingual misoprostol as facilitator in first trimester medical termination of pregnancy (MTP) by surgical method. This was a prospective open label study conducted at a tertiary center. A total 150 patients at 6-12 wks gestation requesting for MTP were randomized into two groups. Patients in study group (n=75) received sublingual misoprostol three hours before surgical abortion and in control group (n=75) directly underwent surgical abortion without prior cervical priming with misoprostol. The outcomes of both groups were recorded in terms of baseline cervical dilatation, need of additional cervical dilatation, intraoperative blood loss, operative time and procedure related complications. The results were statistically analyzed using student-t test and chi-square test. p-value of <0.05 and <0.001 were considered significant and highly significant respectively. The mean baseline cervical dilatation was significantly more in study group compared to control group (8.6±1.3mm versus 5±2.3mm; p <0.001) and the operative time and intraoperative blood loss were also less (p<0.001). Higher incidence of side effects like nausea, vomiting and pyrexia were recorded in sublingual misoprostol group but were well tolerable to the patients. Sublingual misoprostol is an effective and safe drug for cervical priming prior to surgical evacuation and has good patient acceptability.

Vaginal misoprostol for cervical priming before dilation and curettage procedures on premenopausal and postmenopausal women

Evidence Based Women’s Health Journal 2013, 3:39–44 Introduction Misoprostol has been proved to be a very effective cervix softening agent before termination of pregnancy. This beneficial effect may make misoprostol a desirable agent for cervical dilatation in nonpregnant women. The aim of the study was to investigate the efficacy of preoperative vaginal application of misoprostol as a cervix priming agent before dilatation and curettage procedures in premenopausal and postmenopausal women. Methods A randomized controlled clinical trial was carried out among 200 women (100 premenopausal women and 100 postmenopausal women) who were divided into two treatment groups: one group was treated with misoprostol (the study group) and the other was treated with placebo (the control group). The study group received two tablets of 400mg misoprostol vaginally. The control group received two placebo tablets of 500 mg metronidazole vaginally. Main outcome measure Women were assessed at the beginning of the procedures for baseline cervical width, need for further cervical dilatation, duration of the procedure, complications during dilatation, and associated side effects were also recorded. Results The premenopausal and postmenopausal women who received misoprostol had higher baseline cervical dilatation compared with women in the placebo group (P = 0.001). In premenopausal women, the mean cervical dilatation was 6.1 mm ( ± 1.4) in the misoprostol group compared with 3.3 mm ( ± 1.1) in the placebo group. The misoprostol cervical ripening effect on postmenopausal women was 4.2 mm ( ± 0.9) compared with 3.1 mm ( ± 0.8) in the placebo group; hence, further cervical dilatation was required in women of the placebo group, with a statistically significant difference between premenopausal (P = 0.002) and postmenopausal women (P = 0.006). Misoprostol helped in reducing the time taken for dilatation, with a statistically significant difference between premenopausal (P = 0.001) and postmenopausal women; however, time was much shorter in premenopausal women (P = 0.01). Blood loss and degree of resistance were less evident with the use of misoprostol among premenopausal and postmenopausal women, without a statistically significant difference. There was no statistically significant difference with respect to the incidence of misoprostol-related adverse effects and complications. The majority (96% of premenopausal and 94% of postmenopausal women) found vaginal misoprostol to be acceptable. Conclusion Vaginal misoprostol has promising beneficial effects when used for cervical priming in premenopausal and postmenopausal women with tolerable minor side effects.

Oral misoprostol is an effective and acceptable alternative to vaginal administration for cervical priming before first trimester pregnancy termination

BackgroundCervical priming agents mainly prostaglandins in different doses and routes are used during first trimester vaccum aspiration to prevent cervical injury and shorten the abortion procedure. This study was carried out to assess women's acceptability, the efficacy and side effects of oral versus vaginal administration of misoprostol in facilitating cervical dilatation prior to first trimester vaccum aspiration. MethodsA randomised control study where 120 women were divided in oral (51) and vaginal (69) group. Each group received 400 mcg of misoprostol either orally or vaginally 04 h prior to first trimester pregnancy termination. Baseline cervical dilatation, women's acceptability and side effects and complications were noted in both the groups. ResultsThere was no difference between the oral and vaginal misoprostol groups with respect to mean cervical dilatation (5.53 mm vs 5.43 mm; p > 0.05). A total of 88% of women in the oral group expressed satisfaction with the route of misoprostol administration as compared to 74% in the vaginal route. The women in the vaginal group were experienced more preoperative vaginal bleeding (43% vs 25%). ConclusionOral administration of misoprostol is an effective alternative to vaginal administration in preinduction cervical ripening prior to first trimester pregnancy termination.

A comparative study between isosorbide mononitrate (IMN) versus misoprostol prior to hysteroscopy

Abstract Objective To compare the efficacy of a nitric oxide donor (isosorbide mononitrate) and a prostaglandin E1 analogue (misoprostol) for cervical priming before hysteroscopy. Design Comparative clinical trial. Methods A total of 162 patients with diagnosed intrauterine lesions scheduled for hysteroscopy were allocated to two groups: in group A patients ( n =81) IMN 40mg was inserted into the posterior fornix of the vagina while misoprostol 200μg was inserted into the posterior fornix of the vagina in group B patients ( n =81). Results There was no significant difference between IMN and misoprostol with regard to the duration of application or difficult dilatation. In contrast, there was a significant difference between IMN and misoprostol with regard to baseline cervical dilatation (5mm for IMN and 8mm for misoprostol) and duration of dilatation (73s for IMN and 49s for misoprostol). There was no significant difference between IMN and misoprostol with regard to nausea, vomiting and hot flushes. In contrast, there was a significant difference between IMN and misoprostol with regard to abdominal pain (17 cases for IMN and 55 cases for misoprostol) and headache (65 cases for IMN and 9 cases for misoprostol). Conclusion Misoprostol is superior to isosorbide mononitrate regarding better baseline cervical dilatation, less duration of dilatation, less incidence cervical injury and finally better feasibility of the procedure.

Outpatient cervical ripening before first‐trimester surgical abortion: a comparison between misoprostol and isosorbide mononitrate

Vaginal administration of prostaglandin analogues as well as nitric oxide donors before first-trimester surgical abortion has been shown to induce effective cervical ripening. In addition, nitric oxide donors, such as isosorbide mononitrate and nitroglycerin, have been associated with a patient-friendly side-effect profile when administered 3 h before the surgical procedure. We wanted to compare the cervical ripening effect and possible side effects of isosorbide mononitrate and the prostaglandin analogue misoprostol when self-administered at bedtime the evening before surgical abortion. One hundred and twenty nulliparous women scheduled for suction termination of pregnancy in the first trimester were randomly assigned to receive per vaginam either 40 mg of isosorbide mononitrate or 200 microg of misoprostol. Sixty of the women were included for assessment of cervical ripening as well as evaluation of side effects. The other 60 women were recruited for assessment of side effects only. Cervical ripening was evaluated by measuring baseline cervical dilation and the cumulative force to dilate the cervix to 9 mm by means of a cervical tonometer. For assessment of side effects, the women were asked to complete a symptom questionnaire. Cervical resistance was significantly higher in women treated with isosorbide mononitrate compared to misoprostol (median cumulative force 73 versus 15 N). Common side effects of misoprostol were abdominal pain (69%), nausea (44%), and vaginal bleeding (66%), while in the isosorbide mononitrate group headache was frequently experienced (79%). In both treatment groups, the frequency and intensity of side effects gradually increased during the treatment interval. Misoprostol induced a more pronounced cervical ripening than isosorbide mononitrate, but both regimens were associated with a high frequency of side effects.

Intracervical sodium nitroprusside versus vaginal misoprostol in first trimester surgical termination of pregnancy: a randomized double-blinded controlled trial

Results from small-scale randomized studies on the effectiveness of different preparations of nitric oxide donors in cervical priming before first trimester termination of pregnancies are not consistent. We compared sodium nitroprusside gel to misoprostol, the standard agent for cervical priming in this randomized double-blinded controlled trial. Two hundred pregnant patients between 8 to 12 weeks admitted for surgical termination of pregnancy were recruited. They were randomized into either 400 microg vaginal misoprostol and intracervical placebo gel, or 10 mg intracervical sodium nitroprusside gel and placebo tablets 3 h before the procedure. The baseline cervical dilatation and cumulative force required to dilate the cervix from 4 to 9 mm were measured with a tonometer. Blood pressure was measured and side effects were assessed. The cumulative force to dilate the cervix from 4 to 9 mm was significantly higher in the sodium nitroprusside group, and the difference remained when a sub-group analysis was performed according to parity. Baseline cervical dilatation, duration of operation and operative blood loss were all in favour of misoprostol. Transient drop in blood pressure was observed after sodium nitroprusside treatment. Intracervical sodium nitroprusside is not as effective as misoprostol in cervical priming.

Oral versus vaginal misoprostol administered one hour before surgical termination of pregnancy: a randomised controlled trial

To assess the efficacy of oral and vaginal misoprostol as cervical priming agents administered 1 hour before first trimester surgical termination of pregnancy. A randomised controlled trial. Chelsea and Westminster Hospital, London. Pregnant women of 10 weeks or less gestation attending the termination of pregnancy clinic. Ninety eligible women were recruited to the study during September 2001 and September 2002. Women were randomised to one of the three groups: misoprostol administered orally (400 microg), misoprostol administered vaginally (800 microg) and standard care (no cervical priming agent) administered prior to surgical termination of pregnancy. Under general anaesthesia, and prior to the operation, a cervical tonometer was used to determine the main outcome measures. Baseline cervical dilatation and the cumulative force required to dilate the cervix from 3 to 9 mm. There was no significant difference in the mean baseline cervical dilation (P= 0.16) or the cumulative force required to dilate the cervix (P= 0.12) between the three randomised groups. No cervical priming effects were detectable with oral or vaginal misoprostol administered 1 hour before first trimester surgical termination of pregnancy.

Cervical priming with sublingual misoprostol vs. 15-methyl-prostaglandin F 2α prior to surgical abortion

Objective To compare the efficacy and tolerability of sublingual misoprostol with those of intramuscular 15-methyl-prostaglandin F 2α (15-M-PG F 2α) for cervical dilation prior to vacuum aspiration (VA) in first-trimester pregnancy termination. Methods Sixty pregnant women requesting pregnancy termination between the 9th and 12th week were randomized to receive 400 μg of sublingual misoprostol or an intramuscular injection of 125 μg of 15-M-PG F 2α 2 h prior to vacuum aspiration. Baseline cervical dilation prior to vacuum aspiration was measured using Hegar's dilators. Other variables assessed included procedure duration, intraoperative blood loss, and associated adverse effects. Patient acceptability was assessed by questionnaires completed at the time of discharge from the hospital. Results Mean cervical dilation at vacuum aspiration was significantly greater in the misoprostol group than in the 15-M-PG F 2α group (8.8 vs. 7.6 mm; P<0.01), and preoperative adverse effects were significantly less frequent in the sublingual misoprostol group ( P<0.05). However, procedure duration and intraoperative blood loss were similar in both groups. The acceptability rates were 93.3% in the sublingual misoprostol group and 76.6% in the 15-M-PG F 2α group, respectively; however, 6.6% patients in the sublingual misoprostol group thought that the tablets had an unpleasant taste. Conclusion Sublingual misoprostol appears to be an effective alternative to intramuscular 15-M-PG F 2α for cervical dilation prior to vacuum aspiration in first trimester pregnancy. In addition, misoprostol is inexpensive and convenient to use and has higher patient acceptability rates.

A randomized comparison of sublingual and vaginal misoprostol for cervical priming before suction termination of first-trimester pregnancy

This randomized trial compares the efficacy and side effects of sublingual and vaginal misoprostol for cervical priming before first-trimester pregnancy termination. One-hundred pregnant women between 6 and 12 weeks of gestation opting for termination of pregnancy by suction evacuation were included in this study. The women were randomly allocated into two groups. Group 1 received 400 μg of sublingual misoprostol and group 2 received 400 μg of vaginal misoprostol 2 h prior to suction evacuation. The abortion was carried out by suction evacuation using a Karman's cannula attached to an electrically operated suction machine under intravenous analgesia. Baseline cervical dilatation, duration of the procedure, operative blood loss, side effects and complications were noted in both groups. There was a significant difference between the sublingual and vaginal misoprostol groups with respect to mean cervical dilatation (8.6 mm vs. 6.8 mm, p < 0.05). However, the duration of the procedure (3.03 min vs. 3.16 min) and the amount of blood loss (29 mL vs. 31.2 mL) were not significantly different between the two groups. The women in the sublingual group experienced significantly more shivering and preoperative vaginal bleeding (68% vs. 56%, p < 0.05). None of the women in the two groups had either uterine perforation or excessive hemorrhage. In our study, sublingual misoprostol (400 μg) was significantly more effective in facilitating cervical dilation prior to surgical abortion than vaginal misoprostol.

Oral misoprostol vs. vaginal gemeprost prior to surgical termination of pregnancy in nulliparae.

To compare the efficacy and side-effects of intravaginal gemeprost with those of oral misoprostol for cervical ripening prior to first-trimester pregnancy termination in nulliparous women. Retrospective analysis of surgical terminations of pregnancy performed before 90 days of gestation. Intravaginal gemeprost 1 mg or oral misoprostol 800 micro g was administered 2 h before the procedure. In total, 746 women were enrolled into the study, 84 received intravaginal gemeprost and 662 oral misoprostol. Median baseline cervical dilatation was significantly greater in women who received misoprostol before the operation than in those who received gemeprost (7 mm vs. 3 mm; p < 0.0001). The incidence of fever, vomiting and diarrhea was not different between the two groups. The incidence of abdominal pain with request for pain medication, emergency admission to operating room due to vaginal bleeding, hospital stay longer than 24 h and surgical repair of cervical injury due to Hegar dilatation was significantly higher among the gemeprost group than the misoprostol group. In cervical priming prior to first-trimester pregnancy termination in nulliparous women, oral misoprostol is more effective and is associated with fewer side-effects and complications than intravaginal gemeprost.

A randomized controlled comparison of sublingual and vaginal administration of misoprostol for cervical priming before first-trimester surgical abortion

Objective The purpose of this study was to compare the effectiveness of the sublingual and vaginal administration of misoprostol for cervical priming before surgical termination of pregnancy. Study design In a randomized controlled trial, 74 primigravid women who were undergoing surgical abortion were assigned randomly to receive misoprostol (400 μg) sublingually or vaginally. Results There was no statistically significant difference in the cumulative force that was required to dilate the cervix to 9 mm, for baseline cervical dilatation, for priming to abortion interval, for operating time, or for intraoperative blood loss between the two groups. Women in the sublingual group had more nausea ( P = .008), vomiting ( P = .01), diarrhea ( P = .01), and unpleasant mouth taste ( P = .0001) compared with the women in the vaginal group. In the sublingual group, 65% of women were satisfied with the route of misoprostol administration compared with 78% in the vaginal group ( P = .11). Most of the staff members (84%) said that they would recommend the sublingual administration of misoprostol ( P = .0001). Conclusion The sublingual administration of misoprostol is an effective alternative to vaginal administration for cervical priming before surgical abortion; despite a higher incidence of side effects, there was high patient and staff acceptability.