|Year : 2018 | Volume
| Issue : 1 | Page : 34-37
Randomized comparative clinical study of the efficacy and safety of intracervical prostaglandin E2 with intravaginal prostaglandin E1 in induction of labour and its obstetric outcome
Archana Sinha1, Sadia Parween1, Smita Kumari1, Dipali Prasad1, Neeru Goel1, Shishir Kumar2
1 Department of OBG, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-14, Bihar, India
2 Department of PSM, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna-14, Bihar, India
|Date of Web Publication||10-Dec-2020|
Senior Resident, Department of OBG, IGIMS, Sheikhpura, Patna-14, Bihar
Source of Support: None, Conflict of Interest: None
Background : This comparative study was conducted to compare the efficacy and safety of 50 μg of intravaginal misoprostol with 0.5 mg of intracervical dinoprostone gel in terms of the induction-initiation interval, induction- delivery interval , mode of delivery and associated maternal and fetal complications.
Methods: 50 patients who were admitted for induction of labour were included in this study. They were randomly selected to receive either intravaginal misoprostol or intracervical cerviprime gel. 25 women received intravaginal 50 μg Misoprostol (Group A) every 4 hours for maximum of 6 doses and 25 women received 0.5 mg of intracervical cerviprime gel (Group B) till maximum of 3 doses. Comparison was done in terms of time taken for induction to delivery, mean time taken for onset of labour, mode of delivery , maternal complications, APGAR score at 1 and 5 minutes and the neonatal outcome in either of the groups.
Result: The mean time taken for onset of labour was less in the misoprostol group than in the cerviprime group (6.7 hours v/s 7.5 hours, P = 0.47). Similarly duration from induction to delivery was less (23.5 hours v/s 25.8 hours, P >0.33) for misoprostol than cerviprime gel. Cesarean section rate was slightly less in misoprostol group (40% v/s 44%). Maternal complications were minimal in either group & the neonatal outcome was good in both the groups. The induction cost was much less in the misoprostol group.
Conclusion: Compared to cerviprime gel; misoprostol is safe, efficacious, cheap, well tolerated drug by mother and fetus. It was found to be a better inducing agent, has short induction to delivery interval thus short duration of labour.
Keywords: Dinoprostone, Induction of Labour, Misoprostol
|How to cite this article:|
Sinha A, Parween S, Kumari S, Prasad D, Goel N, Kumar S. Randomized comparative clinical study of the efficacy and safety of intracervical prostaglandin E2 with intravaginal prostaglandin E1 in induction of labour and its obstetric outcome. J Indira Gandhi Inst Med Sci 2018;4:34-7
|How to cite this URL:|
Sinha A, Parween S, Kumari S, Prasad D, Goel N, Kumar S. Randomized comparative clinical study of the efficacy and safety of intracervical prostaglandin E2 with intravaginal prostaglandin E1 in induction of labour and its obstetric outcome. J Indira Gandhi Inst Med Sci [serial online] 2018 [cited 2022 Jan 20];4:34-7. Available from: http://www.jigims.co.in/text.asp?2018/4/1/34/302981
| Introduction :|| |
Induction of labour is defined as artificially initiating uterine contractions before the spontaneous onset of labour, with or without ruptured membranes. It is indicated when the benefits to either mother or fetus outweigh those of continuing the pregnancy.
Among the various methods available for induction of labour, prostaglandins are especially useful because of their short induction-delivery duration, easy storage, low maternal and fetal complications, easy availability and lower failure rates. Prostaglandins are also used for cervical ripening before labor induction,. Currently, two prostaglandin analogs PGE1 (Misoprostol) and PGE2 (Cerviprime gel) are available for the purpose of cervical ripening. Misoprostol (PGE1) was the first synthetic prostaglandin analogue to be made available for the treatment of peptic ulcer. Impressed by its stimulant actions on the uterus, Sanchez Ramos in 1993 used it for the management of several obstetric conditions. Misoprostol is available as 25, 50, 100, 200 microgram tablets. Cerviprime (PGE2) is a synthetic preparation of naturally occurring prostaglandin E2. PGE 2 gel is available in 2.5 ml syringe for an intracervical application of 0.5 mg of cerviprime. When cervical conditions are unfavorable, the most frequent form of inducing labor in our country is to administer intravaginal or intracervical prostaglandins. Dinoprostone is an unstable product at room temperature, expensive and exclusively administered vaginally. Misoprostol or prostaglandin E1 is inexpensive, stable at room temperature and can be taken orally, vaginally or sublingually. High drug doses and short intervals can trigger maternal-fetal complications, among which uterine hyperstimulation, both with and without altered fetal cardiotocographic registers is dangerous, and at times, has led to its limited use. Over the years, different regimes have been explored to find the optimum dose.
Prolonged gestational age is the most common cause for induction of labor in obstetrics practice. Induction of labor may be difficult or unsuccessful with subsequent cesarean delivery.
The present study was taken to analyse and compare the efficacy and safety of prostaglandin E1 (misoprostol) and prostaglandin 2( dinoprostone) for induction of labour.
| Materials and Methods :|| |
The present study was conducted in the Department of Obstetrics & Gynaecology of IGIMS, Patna from November 2015 to December 2016. The present study was prospective cohort study. Study protocol was approved by the Institutional Ethics Committee and written informed consent was obtained from all the women or their attendant.
- Both primigravida and multigravida
- singleton gestation
- with cephalic presentation,
- having indication of vaginal delivery were included in the study.
- cephalopelvic disproportion,
- multiple pregnancy,
- placenta praevia
- previous uterine surgery,
Indication for Induction:
- Post maturity (more than 41 wks),
- premature rupture of membrane,
- pre-eclampsia, PIH
- cholestasis of pregnancy
- intrauterine death,
- congenital anomalies,
- intrauterine growth retardation
- fetal distress
- Gestational Diabetes Mellitus
A total of 50 women with indications for induction of labour were selected for the study and were divided into two groups of 25 each on the basis of random number table.
Group A : Control group- of prostaglandin E1( Misoprostol) tablet was administered intravaginally (50 μg). The tablet was repeated every 4 hours for a maximum of 6 doses.
Group B : study group- of prostaglandin E2 (Dinoprostone gel) was administered intracervically (0.5 mg) and repeated after 6 hours, if required for a maximum of 3 doses for a period of 24 hrs. Dinoprostone was avoided in patients having premature rupture of membranes for the fear of washing away of the gel by the liquor. Both the drugs were avoided in patients diagnosed with bronchial asthma and glaucoma.
During drug therapy, maternal status, foetal status and progress of labour were observed carefully. Progress of labour was observed and noted by per abdominal and vaginal examination. Uterine contractions in terms of frequency and duration per 10 minutes were noted. Adequate contractions were defined as 3 per 10 minute each lasting for 45 seconds. Tachysystole, hypertonus and hyperstimulation were noted. The patient was considered in the active phase when there was cervical dilatation was more than 4 cm. Women in labour were cared for, according to current obstetric practices. When they entered active phase, depending on the pattern of uterine contractility, syntocinon was used for augmentation if the uterine contractions were not adequate. If women did not reach active phase even after 18 hours of last dose of the drugs it was labelled as failed induction and caesarean section was done for failed induction. The primary outcome measures were induction to onset of labour, induction to delivery interval, maternal and fetal complications. Other measures studied were mode of delivery, need for caesarean section and side effects.
Efficacy and safety of misoprostol as a method of cervical priming and labour induction as compared to dinoprostone was assessed.
Therapy was discontinued if woman developed severe diarrhoea, vomiting, signs of foetal or maternal distress, uterine hypercontractility, tachycardia, fever or rigors.
Foetal outcome was evaluated by Apgar score at 1 min and 5 min of life. Maternal outcome was evaluated by any complication and side effects of both the drugs.
Analytical Method- Student t-test
| Results :|| |
Patient population was divided in two groups; group A (control group): 25 Patients who received 50 μg Misoprostol per vaginally and group B (study group): 25 Patients who received cerviprime gel 0.5 mg PGE2 intracervically. Most of the patients in both groups were between 20-30 years. Mean age difference was statistically significant in both groups (23.08 ± 2.12 yrs vs 25.28 ± 4.48 years)(p= 0.03) [Table 1]. Patients in group A was younger as compared to patients in group B. There was no significant difference of bishop score in both groups (3.2 ± 0.82 vs3.4 ± 1.0) (p=0.44) [Table 1]. Mean difference between the parity of both the groups was not statistically significant (1.2 ± 0.40 yrs vs1.44 ± 0.507; p= 0.07)[Table 1]. Mean number of dosages of drugs in both the groups were more or less similar ( 2.1 vs 2.24) [Table 2]. The mean time taken for onset of labour was less in the misoprostol group (6.7 hours v/s 7.5 hours) (p=0.47) [Table 3]. Thus Misoprostol leads to early labour but statistically the difference was insignificant. The mean time taken for induction to delivery was less in misoprost group and thus early delivery as compared to the cerviprime (13.5 hrs vs 15.8 hrs) but the difference was statistically insignificant (0.33) [Table 4].
|Table 2: Distribution According to Number of Doses required for induction|
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|Table 3: Distribution according to induction to initiation of labour duration|
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There were more (44%) cesarean deliveries in group B (cervigel) than in group A(misoprost) (40%) [Table 5]. Caesarean section was done mostly for fetal distress in both groups. Failed induction was observed in two patient in group A and one patient in group B. Premature rupture of membranes was the major indication for induction in group A (40%) while postdated pregnancy was major indication in group B (56%). But collectively in both the groups postdated pregnancy was the major indication [Table 7].
Maternal side effects were minimal in both the groups. 88% patient in group A and 84% in group B delivered smoothly without experiencing any significant side effect. In misoprost group, 4% patients had fever with chills, 8% of patients had abruption placentae. In group B, 4% had fever, 4% had only shivering, 4% atonic PPH and 4% had cervical tear [Table 9].
No significant difference was observed the mean APGAR score at 1 minute (6.6 vs 6.5 ; p = 0.9) and 5 minute ( 8.0 vs 8.0 ; p=1.0) [Table 6]. NICU admission in Group A was 3 (12%) and in Group B was 2(8%). Neonatal death in Group A was 2(8%) and in Group B was 1(4%) [Table 8].
| Discussion :|| |
The introduction of Prostaglandins to clinical practice, particularly their local use for cervical ripening, has decreased major difficulties of labour induction. Induction to delivery interval has been decreased dramatically by introduction of prostaglandins. Similarly it also decreased associated complication of amnionitis and fetal infection. It is a very cost effective drug for cervical ripening and labour induction.
In our study postdated pregnancy was the most common indication for induction in group B ( 56%) and PROM was most common indication in group A . Greagsons et al. in their study showed that 95% patients in misoprostol group and 94% in cervigel group were induced for postdatism. Similarly C. N. Sheela et al. demonstrated that postdatism (36% & 32% respectively) was most common indications in both groups. Our study is similar to these studies in case of Group B. Whereas in case of Group A in contrast to the above studies the most common indication is not postdatism but PROM (40%).
Misoprostol has been found to be more effective for earlier onset of labour. The mean time taken for onset of labour was less in misoprost group as compared to cerviprime group (6.6 hours vs. 7.5 hours). Also takes lesser time from induction to delivery. The mean induction to delivery interval was less in the misoprost group as compared to cervigel group (13.5 hours vs. 15.8 hours). In the study of Murthy Bhaskar Krishnamurthy in 2006, induction delivery interval was shorter in the misoprostol group. Other reported studies Sebiha Ozkan etal in 2009 and Cheng SY etal in 2008 also had parallel observation. Thus misoprostol reduces the mean duration of labour which reduces the duration of suffering of a patient in labour and also provides fast delivery which is required in cases of premature rupture of membranes, eclampsia and fetal distress.
The misoprostol had decreased rate of Cesarean section (40%) compared to cerviprime (44%). 56% of patients in both groups delivered vaginally. 4% of patients in misoprost group delivered by forceps delivery. Although a little bit higher cesarean deliveries were done in group B (44%) than in group A (40%), but the difference was not significant. This was consistent with the study of Sahu Latika et al. (8% vs. 20%) and also with the study of Patil Kamal et al. and Murthy Bhaskar et al. These findings are in contrast with the reports of Wing et al, 1998 who could not find any difference in two groups. However they used 25 μg misoprostol as compared to 50 μg, misoprostol in our study.
Mean APGAR score at 1 minute and 5 minute was also found to be more or less similar in both groups. Sahu Latika et al. also had 12% newborns with APGAR <7 at one minute in group A which is consistent with our study.
| Conclusion :|| |
Our study results revealed that, misoprostol is better inducing agent as compared to the cerviprime gel because it has short induction to initiation of labour duration as well as induction to delivery intervals and thus short duration of labour. The percentage of caserean delivery was less in misoprost group. Although meconium stained liquor was more in misoprostol group, it did not have any effect on the neonatal outcome. Misoprostol also does not need cold chain storage and is cheaper. Therefore, misoprostol is cheaper than dinoprostone, easy to administer by intravaginal route and does not require refrigeration. This indicates that misoprostol is a better, effective and safe alternative drug for induction of labour.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]