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Comparative Study of Sublingual versus Vaginal Misoprostol on Preoperative Cervical Priming in First Trimester Abortion
Parneet Kaur*, Manjeet Kaur*, balwinder Kaur**, Manjit Kaur MOhi†; KhushPreet Kaur‡, Preeti jindal¶
Objective: To compare the effect of sublingual versus vaginal misoprostol on preoperative cervical priming in first trimester
abortion. Material and methods: One hundred women seeking first trimester abortion were randomized into either sublingual
or vaginal groups of 50 each. They were given 400 µg misoprostol via sublingual or vaginal route for cervical priming three hours before the procedure. The outcome measures assessed were cervical dilatation before surgery, duration of procedure, intraoperative blood loss and preoperative side effects. Results: Subjects in the sublingual group achieved significantly higher
mean cervical dilatation compared to vaginal group (8.34 ± 0.62 mm vs 7.60 ± 0.67 mm, p = 0.0001). The mean duration of procedure for sublingual group was significantly lower compared to the vaginal group (2.62 ± 0.64 minutes vs 3.17 ± 0.71 minutes, p = 0.0001). The mean intraoperative blood loss was found to be more in sublingual group as compared to vaginal group (34.90 ± 10.90 ml vs 32.90 ± 7.42 ml), but the difference was not significant (p = 0.286). The sublingual group experienced more preoperative side effects such as pain, bleeding, nausea and shivering as compared to vaginal group. Conclusion: Sublingual misoprostol is more effective and convenient route than vaginal misoprostol for preoperative cervical
priming in first trimester abortion.
Keywords: Misoprostol, sublingual, vaginal, cervical priming
An abortion is termination of a pregnancy either worldwide. The sublingual route appears as effective spontaneously or intentionally, before the fetus as vaginal administration and requires less time for develops sufficiently to survive independently. priming, but is associated with more side effects.4 The traditional method for termination of early In order to dilate the cervix preoperatively, the subject pregnancy has been priming of the cervix followed must receive the agent at least 3-4 hours prior to the by evacuation by suction aspiration performed under anesthesia or sedation.1 Cervical priming can be achieved with the use of prostaglandins or hydrophilic dilators.2 Various prostaglandin E1 (PGE1) analogs can be used, but misoprostol (15-deoxy-16-hydroxy- The present study was undertaken to compare the 16methyl-PGE1) is cheap, easily stored and associated effect of 400 µg sublingual and 400 µg vaginal with fewer side effects,3 so, it is most commonly used misoprostol on preoperative cervical priming in first trimester abortion.
MAteriAl And MethOds
The present study was conducted in the Dept. of *Associate Professor **Assistant Professor Obstetrics and Gynecology, Government Medical College †Professor and Head and Hospital, Patiala, Punjab. One hundred women ‡Professor and Unit Head ¶Junior Resident seeking first trimester abortion were randomized into Dept. of Obstetrics and Gynecology either sublingual (Group A) or vaginal group (Group Government Medical College and Hospital, Patiala, Punjab address for correspondence
B) of 50 each. They were given 400 µg misoprostol via sublingual or vaginal route for cervical priming three H. No.: 151, Punjabi Bagh hours before the procedure. The inclusion criterion Near Klair Orthopedic Centre, Patiala, Punjab - 147 001 was young healthy women with period of gestation Indian Journal of Clinical Practice, Vol. 23, No. 9 February 2013
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upto 12 weeks. Gestational age was estimated clinically and was confirmed by ultrasonography in case of Table 1. Subject Characteristics
any doubt. Subjects with history of previous uterine Parameters Sublingual
surgery, allergy or contraindications to prostaglandins, hemoglobin <9 g/dl, pelvic inflammatory diseases, (Group A)
ectopic pregnancy, multiple pregnancy and uterine 29.78 ± 4.03 29.84 ± 3.61 anomalies were excluded. Detailed history was taken and a complete physical and obstetrical examination was done. Routine investigations including hemoglobin, urine analysis and blood group were done.
The women were admitted on the morning of the procedure and misoprostol was administered either vaginally or sublingually by doctors other than surgeons Gestational 7.76 ± 1.37 assessing the treatment outcome. Their pulse, blood pressure, temperature and other side effects associated The values are expressed as mean ± SD.
with misoprostol including pain, nausea, vomiting, diarrhea, fever, shivering and bleeding per vaginum were recorded. The severity of preoperative abdominal Table 2. Showing Comparison of Cervical Dilatation
pain experienced by the subject was assessed as Score 1 - no pain, Score 2 - mild pain and Score 3 - severe Cervical dilatation Sublingual group
pain requiring analgesics. Similarly, preoperative (Hegar's dilator)
vaginal bleeding was measured as: Score 1 - Spotting or minimal bleeding, Score 2 - bleeding amount similar to menstrual flow and Score 3 - heavy bleeding with clots.
The abortion was carried out by suction evacuation under general anesthesia. After three hours, outcome measures assessed were cervical dilatation, duration of procedure, intraoperative blood loss and preoperative side effects. The degree of cervical dilatation before vacuum aspiration was measured by passing Hegar's dilators. Duration of procedure was measured from the start of dilatation of cervical os until end of curettage and intraoperative blood loss was measured with a ‘t' and ‘p' value measuring cylinder. Following the procedure, the subjects were kept in hospital for four hours for observation. The final Table 3. Showing Comparative duration of Procedure
outcome regarding efficacy, side effects and acceptability of treatment was assessed. Duration of
Table 1 summarizes the characteristics of subjects recruited in each group. There was no significant difference with respect to age, gravida, parity and gestational age between the two groups. Mean cervical dilatation achieved in sublingual group was significantly higher compared to vaginal group (8.34 ± 0.62 mm vs 7.60 ± 0.67 mm, p = 0.0001) (Table 2). The mean duration of procedure for sublingual group was significantly lower compared to vaginal group ‘t' and ‘p' value (2.62 ± 0.64 minutes vs 3.17 ± 0.71 minutes, p = 0.0001). Indian Journal of Clinical Practice, Vol. 23, No. 9 February 2013
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5-10 minutes in all the subjects. Sublingual route was Table 4. Showing Comparison of Intra-operative
more acceptable to the subjects than vaginal route and Blood Loss in Group A and B none of the subjects in sublingual group complained of Blood loss (ml)
any unpleasant taste.
group (Group A)
First trimester abortion by surgical methods has been widely used in modern obstetrics. Vacuum aspiration is a commonly used method for first trimester abortion and is one of the most common surgical procedures performed worldwide.6 Cervical dilatation is the most critical step in vacuum aspiration as most cervical and ‘t' and ‘p' value uterine injuries are due to forceful dilatation of cervix. Adequate dilatation decreases pain and duration of surgery and increases operative ease. Previously, laminaria tent, gemeprost and PGE2 gel have been Table 5. Showing Comparison of Side Effects in
used for cervical ripening.7 These days misoprostol, a synthetic PGE1 analog, has become popular for its Sublingual Vaginal
‘p' value Results
effectiveness and for its other advantages like less (Group A) (Group B)
cervical injuries, minimal intraoperative blood loss, reduced requirement of general anesthetics and availability in different dosage forms. It can be given by oral, intravaginal, sublingual or intrarectal route. The present study observed that the cervical dilatation achieved with misoprostol was favorable among the sublingual group compared to the vaginal group. The observed difference can be attributed to the different absorption kinetics and subsequent more systemic bioavailability with the sublingual and vaginal routes. Similar results were found by Saxena et al,8 Parveen et al9 and Vimala et al.10The duration of procedure was less in the sublingual The mean intraoperative blood loss was found to be group. This can be explained on the basis of the more more in sublingual group as compared to vaginal group cervical ripening and dilatation achieved in this group. (34.90 ± 10.90 ml vs 32.90 ± 7.42 ml), but difference was Saxena et al,8 Parveen et al,9 Vimala et al10 and Carbonell not significant (p = 0.286) (Table 4).
et al11 have also reported similar findings.
In the present study, subjects in sublingual group The mean intraoperative blood loss was found to be experienced more preoperative side effects as slightly more in sublingual group as compared to compared to vaginal group such as pain (18 vs 16, vaginal group, which is same as reported by Parveen p = 0715), bleeding (14 vs 12, p = 0.814), nausea (7 vs 2, et al9 and Tang et al,12 which was not significant. p = 0.081) and shivering (7 vs 3, p = 0.183). None of the subjects in present study experienced fever, diarrhea or In the present study, subjects in sublingual group vomiting. But, the difference of side effects in both the experienced more preoperative side effects as compared groups was not statistically significant (Table 5).
to vaginal group, the most common being the pain No complication occurred in either of the two groups (18 vs 16, p = 0715). Other side effects like bleeding during surgery or in the period of observation. Out (14 vs 12, p = 0.814), nausea (7 vs 2, p = 0.081) and of a total of 50 subjects in vaginal group, in 11 (22%) shivering (7 vs 3, p = 0.183) were also seen slightly subjects, tablet was only partially absorbed, while in more frequently in sublingual group. This increased sublingual group, drug was absorbed completely in frequency of side effects may be explained by the Indian Journal of Clinical Practice, Vol. 23, No. 9 February 2013
ObstetrICs and GyneCOlOGy
higher bioavailability of sublingual misoprostol. None abortion (<14 weeks' gestation). SFP Guideline 20071. of the subjects in the present study experienced fever, diarrhea or vomiting. But, the difference of side effects 6. Ngai SW, Yeung KC, Lao T, Ho PC. Oral misoprostol in both the groups was not significant. versus vaginal gemeprost for cervical dilatation prior to vacuum aspiration in women in the sixth to twelfth week of gestation. Contraception 1995;51(6):347-50.
7. el-Refaey H, Templeton A. Early induction of abortion It is concluded from the present study that sublingual by a combination of oral mifepristone and misoprostol misoprostol is better than vaginal misoprostol for pre- administered by the vaginal route. Contraception operative cervical priming in first trimester abortion. The operative time is also decreased with sublingual 8. Saxena P, Sarda N, Salhan S, Nandan D. A randomised route and it has good patient acceptability rate and no comparison between sublingual, oral and vaginal route significant difference in side effects experienced by the of misoprostol for pre-abortion cervical ripening in first- trimester pregnancy termination under local anaesthesia. Aust N Z J Obstet Gynaecol 2008;48(1):101-6.
9. Parveen S, Khateeb ZA, Mufti SM, Shah MA, Tandon VR, 1. Saxena P, Salhan S, Sarda N. Comparison between the Hakak S, et al. Comparison of sublingual, vaginal, and sublingual and oral route of misoprostol for pre-abortion oral misoprostol in cervical ripening for first trimester cervical priming in first trimester abortions. Hum Reprod abortion. Indian J Pharmacol 2011;43(2):172-5.
10. Vimala N, Mittal S, Kumar S, Dadhwal V, Sharma Y. 2. Fong YF, Singh K, Prasad RN. A comparative study using A randomized comparison of sublingual and vaginal two dose regimens (200 microg or 400 microg) of vaginal misoprostol for cervical priming before suction misoprostol for pre-operative cervical dilatation in first termination of first-trimester pregnancy. Contraception trimester nulliparae. Br J Obstet Gynaecol 1998;105(4): 11. Carbonell Esteve JL, Marí JM, Valero F, Llorente M, 3. el-Refaey H, Calder L, Wheatley DN, Templeton A. Salvador I, Varela L, et al. Sublingual versus vaginal Cervical priming with prostaglandin E1 analogues, misoprostol (400 microg) for cervical priming in first- misoprostol and gemeprost. Lancet 1994;343(8907):1207-9.
trimester abortion: a randomized trial. Contraception 4. Saxena P, Salhan S, Sarda N. Role of sublingual misoprostol for cervical ripening prior to vacuum aspiration in first 12. Tang OS, Mok KH, Ho PC. A randomized study trimester interruption of pregnancy. Contraception comparing the use of sublingual to vaginal misoprostol for pre-operative cervical priming prior to surgical 5. Allen RH, Goldberg AB; Board of Society of Family termination of pregnancy in the first trimester. Hum Planning. Cervical dilation before first-trimester surgical Subtle Cognitive Declines follow Menopause The year after a woman's final menstrual period - a phase classified as early postmenopause - is a time in which subtle changes in cognition occur, researchers found. Compared with women in an earlier stage of menopause known as the late menopausal transition phase, those in early postmenopause scored worse on tests of verbal learning (B = –0.93, p < 0.01) and verbal memory (B = –0.80, p = 0.01), according to Miriam T Weber, PhD, of the University of Rochester in New York, and colleagues. In addition, women in early postmenopause fared worse on measures of fine motor skills (B = -0.70, p = 0.0) and attention/working memory (B = –0.55, p = 0.04), the researchers reported online in Menopause.
Source: Medpage Today Indian Journal of Clinical Practice, Vol. 23, No. 9 February 2013
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