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Volume 13 (4), 2011

A Comparative Study of Intra vaginal Misoprostol and Intra cervical Dinoprostone Gel for Labor Induction in Pregnancy Induced Hypertension Sharma Arti Sharma Utkarsh Gupta Vineeta Chaudhary Anjali Goyal Arunima Hanspal Jairaj

www.ijmch.org

INDIAN JOURNAL OF MATERNAL AND CHILD HEALTH


What is the efficacy and safety profile of vaginal misoprostol versus intra-cervical dinoprostone gel in labor induction in Pregnancy Induced Hypertension? 1

INDIAN JOURNAL OF MATERNAL AND CHILD HEALTH,2009

OCT DEC;13(4)

A Comparative Study of Intra vaginal Misoprostol and Intra cervical Dinoprostone Gel for Labor Induction in Pregnancy Induced Hypertension
Sharma Arti,*@ Sharma Utkarsh,*# Gupta Vineeta,**@ Chaudhary Anjali,*@ Goyal Arunima,***@ Hanspal Jairaj****$
*Assistant Professor, **Professor and Head, ***Senior Resident, ****Professor, Department of Obstetrics & Gynaecology, Department of Pediatrics, Department of Community Medicine, SGRR Medical College & associated SMI Hospital, Dehradun.
# $ @

Correspondence: Dr. Arti Sharma Email: artishubh@yahoo.com

ABSTRACT Research question: What is the efficacy and safety profile of vaginal misoprostol versus intra-cervical dinoprostone gel in labor induction in Pregnancy Induced Hypertension? Settings: Department of Obstetrics and Gynecology, MGMMC and MY Hospital Indore (MP) Study design: Hospital based prospective study Methodology: Two hundred women with PIH above 37weeks of gestation were selected for induction of labor either with misoprostol or dinoprostone gel. They were randomized alternatively into two groups of 100 women each. In our study, 50mcg vaginal misoprostol 4 hourly for a maximum of 4 doses were compared with 0.5mg intra cervical dinoprostone gel 6 hourly for a maximum of 3 doses. Induction to established labor interval, induction to vaginal delivery interval, requirement of oxytocin, reinstallation of drug, side effects and neonatal outcome were compared. Results: Induction to cervical ripening interval and induction to vaginal delivery interval was significantly shorter in misoprostol group than dinoprostone group. Augmentation with oxytocin was required in less number of women in misoprostol group. Prevalence of tachysystole was higher in misoprostol group than dinoprostone. There were no differences in the mode of delivery and neonatal outcome.

Key words: PIH, labor induction, misoprostol, dinoprostone gel.

INDIAN JOURNAL OF MATERNAL AND CHILD HEALTH,2009 INTRODUCTION

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Pregnancy induced hypertension (PIH) continue to be rampant globally. The aim of successful induction of labor is to achieve vaginal delivery when continuation of pregnancy presents a threat to the life or well being of the mother or her unborn child. Induction of labor has a definite role in the management of PIH as it amounts to bring about an end to the maternal and fetal risk due to PIH. The ideal agent for induction of labor should be effective, noninvasive, economical, rapid in action and safe to both mother and fetus. Prostaglandins are one of the most effective means of achieving cervical ripening and induction of labor providing good clinical efficacy and patient satisfaction. The present study aims to evaluate the comparison between intra-vaginal tablet misoprostol (50mcg) versus intra-cervical application of dinoprostone gel (0.5 mg) in induction of labor in cases of PIH.

MATERIALS AND METHODS The present study was carried out on two hundred pregnant women with hypertension, edema and albuminuria. They were selected for induction of labor either with misoprostol (PGE1 analogue) or dinoprostone gel (PGE2). The women were randomized alternatively into two groups of 100 women each. The inclusion criteria were, gestation greater than 37 week, cephalic presentation of a single fetus, Bishops score less than 6, no cephalo-pelvic disproportion, amniotic fluid index of 5 centimeter or more, reactive fetal heart pattern, no history of bronchial asthma, glaucoma, serious cardiovascular, renal, hepatic or endocrinal disorders. Women with following clinical history or findings were excluded from the study; presentation other than cephalic, prior uterine scar, grand-multipara, multiple pregnancy, abnormal fetal heart rate (FHR) tracings, placenta previa, bronchial asthma, glaucoma, hypersensitivity to prostaglandins and patient of known hemoglobinopathies. After a detail history, examination and relevant investigations, informed consent was obtained and women were assigned one of either group. Pre induction Bishops score was recorded in all women. Women in dinoprostone group received 0.5 mg of dinoprostone gel intra-cervically and reinstallation done after 6 hours if required. Women in misoprostol group received 50 mcg of misoprostol tablet intra-vaginally in posterior fornix (half of 100mcg tablet). Subsequent doses were given after every 4 hours up to maximum of 4 doses (200mcg). Continuous maternal and fetal monitoring was carried out in all women. Per vaginal examination was done every 4 hourly in misoprostol group and every 6 hourly in dinoprostone group or earlier when clinically indicated. In both groups, if contractions had failed to setup or they were not adequate oxytocin infusion was started after 4 hours in the misoprostol group and after 6 hours in the dinoprostone group after the last dose. The outcome measure were ; induction to cervical ripening interval, induction to established labor interval, induction to delivery interval, mode and route of delivery, indications for cesarean delivery, number of emergency cesareans performed for fetal distress, number of doses of drugs used, oxytocin augmentation, incidence of adverse effects and postpartum hemorrhage recorded. Neonatal outcome was recorded in every case. 3

INDIAN JOURNAL OF MATERNAL AND CHILD HEALTH,2009 RESULTS

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Table I: Distribution of patients according to Maternal Characteristics


Variables Misoprostol (N = 100) Dinoprostone (N =100)

Booking / Emergency status - Booked - Emergency Age - (19 25 years) - (26 35 years) Parity Primigravida Multigravida

12 % 88 %

10 % 90 %

88 % 12 %

86 % 14 %

76 % 24 %

80 % 20 %

Indication of Induction - Pre Eclampsia - Eclampsia Admission Bishops Score 3 4 5 6

50 % 50 %

50 % 50 %

73 % 25 % 1% 1%

57 % 13 % 15 % 15 %

Majority of women in both groups were un-booked. Maximum numbers of women in both groups were in the early second decade of life and they were mainly primigravidae. In misoprostol group 76% women had Bishop Score 3 whereas in dinoprostone group 57% had Bishop Score 3. Time required for cervical ripening was significantly shorter in misoprostol group than dinoprostone group.

Table II: Distribution of patients according to Induction to cervical Ripening Interval


Time < 8 hrs 8 16 hrs >16 hrs Misoprostol (N=100) 88% 12% 0% Dinoprostone (N=100) 66% 29% 5% P < 0.05

INDIAN JOURNAL OF MATERNAL AND CHILD HEALTH,2009

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Induction to established labor interval and Induction to vaginal delivery interval was significantly shorter in misoprostol group than dinoprostone group. Oxytocin augmentation was required in lesser number of patients in misoprostol group; however tachysystole was noticed more with misoprostol group. Table III: Distribution of patients according to Intra-partum Variables
Variables Misoprostol (N=100) Dinoprostone (N=100)

Induction to established labor interval < 4 hours 95% 4-8 hours 5% > 8 hours 0% Induction to interval * < 8 hours 8-20 hours > 20 hours vaginal delivery 80% 9% 0% 21% 41% 26%

53% 28% 19%

P < 0.05

43% 35% 3% 63% 48% 11%

P < 0.05

Oxytocin augmentation required Re-instillation of drug Tachysystole

P < 0.05

P < 0.05

* Women who underwent cesarean were excluded.

No difference was noted in the overall incidence of spontaneous vaginal deliveries, cesarean section and instrumental deliveries among both groups. The neonatal outcomes were also similar in both groups. Potential adverse effects like nausea, vomiting were reported in few women in dinoprostone group but broncho-spasm was not present in the study population.

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Table IV: Distribution of patients according to Mode of delivery and fetal outcome
Outcome Delivery Spontaneus vaginal Outlet forceps Cesarean section Indications of cesarean section Fetal distress Non progress Failed induction APGAR Score < 7 1 minute 5 minute 80% 9% 11% 6% 4% 1% 77% 4% 19% 12% 1% 6% P>0.05 Misoprostol(N=100) Dinoprostone (N=100)

30% 12%

33% 14%

P>0.05

Meconium passage NICU admissions Hyperbilirubinemia Septicemia Maternal complications Nausea Vomiting Bronchospasm PPH

12%

14%

P>0.05

5% 5%

6% 2%

P>0.05

0% 0% 0% 0%

5% 3% 0% 4%

DISCUSSION The cervical state has a profound influence on the outcome of induced labor. The ability of prostaglandins to make the cervix ripe and soft helps in reducing the unacceptably high incidence of cesarean section for failed induction of labor, especially in nulliparous women with poor cervical scores. Although dinoprostone is the preferred method of induction of labor(1) because of its cost and storage requirement the search for an effective, less invasive, affordable and easily stored labor inducing agent has led to the use of misoprostol. Misoprostol is a prostaglandin E1 analogue, is a potent uterotonic agent that has been shown to be highly effective for cervical ripening and labor induction.(2) In our study induction to cervical ripening interval and induction to vaginal delivery interval was significantly shorter in misoprostol group. Similarly in a study by Nanda et al(3) the mean 6

INDIAN JOURNAL OF MATERNAL AND CHILD HEALTH,2009

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induction to delivery interval was five hours shorter in misoprostol group (13.30 18.74 v/s 18.53 11.33; P =0.011).In contrast a study done by Girija & Manjunath(4) demonstrated that administration of two prostaglandins (25 mcg misoprostol and 0.5mg dinoprostone gel) resulted in similar induction delivery interval (684vs 690 P = 0.1). Shaheen et al(5) did a comparative study of low dose vaginal misoprostol versus oxytocin in induction of labor, and reported that the difference in mean induction to delivery interval (11.2 6 hours in misoprostol group versus 12.26 hours in oxytocin group) was statistically insignificant in two groups, but prevalence of hyper stimulation was not high in misoprostol group. In our study incidence of uterine hyper stimulation were more in misoprostol group. Since Girija S et al(4) and Shaheen et al(5) used 25mcg misoprostol it is possible that because of low dose misoprostol uterine contraction abnormalities were not high in their studies. Alfirevic(6) compared misoprostol with dinoprostone gel and reported that the rate of successful vaginal delivery was increased with misoprostol; however uterine hyper contractility with fetal heart rate changes were more with misoprostol. Our data showed that the oxytocin augmentation was required in less number of women in misoprostol group. In terms of complications uterine tachysystole was reported more in misoprostol group. Nanda et al(3) also reported that the uterine contraction abnormalities occurred more significantly in the misoprostol group as compared to dinoprostone group. Similarly in a study by Hofmeyr et al(7) they reported that though misoprostol was more effective than dinoprostone gel but uterine hyper stimulation was more with use of misoprostol in induction of labor. In our study there was no significant difference between groups for newborn outcome, meconium passage and NICU admissions. Both drugs had no adverse effect on blood pressure of PIH patients in both groups. Induction of labor is common in PIH. In absence of ripe cervix successful vaginal birth is less likely and maternal and fetal risk increases due to PIH. Our study shows that misoprostol and dinoprostone appear to have good efficacy and safety profile for labor induction, however misoprostol compared to dinoprostone proves to be an effective and better method for cervical ripening and induction of labor when combined with judiciously timed amniotomy achieving more vaginal deliveries in women with unfavorable cervix. The additional benefits of misoprostol are, its stability at room temperature, it is cheaper and ease of administration. Therefore it is very useful medication for low resource country as India where refrigerator is not available everywhere and affordability of costly treatment is a big problem for poor patients.

CONCLUSION Misoprostol is one of the most important medications in Obstetrical practice. It is long lasting, cost effective, very potent and a promising drug for labor induction. The present study favors the use of misoprostol as an inducing agent.

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REFERENCES 1. Induction of labor. NICE guidelines July 2008(accessed on September 2008). 2. Sanchez Ramos L, Kaunitz AM, Wears RL, et al. Misoprostol for cervical ripening and labor induction: A Meta analysis. Obstet Gynecol 1997; 89: 633-42. 3. Nanda S, Singhal S R, Papneja A. Induction of labor with intravaginal misoprostol and prostaglandin E2 gel: a comparative study. Trop Doct 2007; 37:21-4. 4. Girija S., Manjunath AP. A randomized controlled trial comparing low dose vaginal misoprostol and dinoprostone gel for labor induction. J Obstet Gynecol India 2011; 61: 2,153-60. 5. Shaheen, Sharma R, Mathur A. Comparative study of low dose vaginal misoprostol versus oxytocin in induction of labor. Journal of SAFOG 2010; 2:3; 193-5. 6. Alfirevic Z: misoprostol for induction of labor. Cochrane Database Syst Rev, 2001;2. 7. Hofmeyr G J and A M Gulmezoglu. Vaginal misoprostol for induction of labor. Cochrane Database Syst Rev, 2001;2.

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