research article

Comprehensive Analysis of 1000 Labour Inductions with Vaginal Misoprostol

Pratibha Devabhaktuni*, Usha Rani Vemuri, Padmaja Allani, Malati Ponnuru, Swathi Gogineni, Deepa, Varada, Nagasree MGS, Krupa Patalay

Modern Government Maternity Hospital, Osmania Medical College, India

*Corresponding author: Pratibha Devabhaktuni, Modern Government Maternity Hospital, Osmania Medical College, India. Tel: +919573703417; Email: dpdnk@yahoo.com

Received Date: 28 April, 2018; Accepted Date: 22 June, 2018; Published Date: 29 June, 2018

Citation: Devabhaktuni P, Vemuri UR, Allani P, Ponnuru M, Gogineni S, et al. (2018) Comprehensive Analysis of 1000 Labour Inductions with Vaginal Misoprostol. Gynecol Obstet Open Acc: OBOA-128. DOI: 10.29011/ 2577-2236/100028

 

1.       Abstract

1.1                Objective: To study the efficacy of Prostaglandin E1 (PGE1), misoprostol, vaginally administered in induction of labour (IOL) for various indications.

1.2.              Material and Method: During 8 months from Jan-Aug 2006, 1000 cases of labour induced with intravaginal misoprostol 25 mcg. fourth hourly, in term gestation and 50 mcg in some preterm gestations, were studied and a critical analysis of the caesarean rate, perinatal mortality, perinatal survival, induction - delivery interval, the number of doses required and complications like PPH, abruption, pyrexia and maternal deaths is reported. This is an observational study.

The indications for labour induction in 1000 were 1. Past EDD, N=-250, Term Gest., N=200, Preeclampsia, N=210, Prelabour rupture of membranes(PROM), N= 170, including term and preterm gestation, Eclampsia, N=60 induced with PGE1 of the total 118 eclampsia cases, Placental abruption, N=49 induced with misoprostol of the total 116 abruption admissions, fetal anomalies requiring induction were N=27, multifetal gestation were N=6, and extra 27 consecutive labour inductions for similar indications were included to make 1000 labour inductions.

1.3.              Results: C. Section rate in1000 deliveries is 11.9%. Caesarean section rate in this study is 11.5% (past EDD, TG, PIH & PROM =99/857). In the very high risk obstetric patients (Eclampsia& Abruption N=109) it is 18% in this study. The number of deliveries after 37wks is 777/1000, the remaining being preterm. The complications like pyrexia, placental abruption, postpartum haemorrhage are very less. There were two maternal deaths in 1000 cases. One was a case of eclampsia, who was admitted with pyrexia in a semi-conscious state died due to probably cerebral haemorrhage. The second lady had PPH, atonic, went into DIC, could not be saved.

1.4.              Discussion: Vaginal misoprostol is a boon for cervical ripening to improve Bishop score, especially in the very high risk obstetric cases , eclampsia and placental abruption where early delivery would save maternal lives.

1.5.              Conclusion: Misoprostol 25mcg. vaginal placement to ripen the cervix and induce labour at term is an excellent method.

2.                   Keywords: Labour induction; PGE1; Vaginal Misoprostol

1.                   Introduction

In developed countries, up to 25% of all deliveries at term now involve induction of labor [1]. WHO general principles related to the practice of induction of labour should be strictly followed. Induction of labour should be performed only when there is a clear medical indication for it and the expected benefits outweigh its potential harms. Consideration must be given to the actual condition, wishes and preferences of each woman, with emphasis being placed on cervical status, the specific method of induction of labour and associated conditions such as parity and rupture of membranes. Induction of labour is recommended for women with prelabour rupture of membranes at term. Low-dose vaginal misoprostol (25 μg, 6-hourly) is recommended for induction of labour [1].  Oral misoprostol (25 μg, 2-hourly) is also recommended for induction of labour [1].

Unpublished data from the WHO Global Survey on Maternal and Perinatal Health, which included 373 health-care facilities in 24 countries and nearly 300 000 deliveries, showed that 9.6% of the deliveries involved labour induction, highest in Sri Lanka, 35.5% [2]. Over the years, various professional societies have recommended the use of induction of labour in circumstances in which the risks of waiting for the onset of spontaneous labour are judged by clinicians to be greater than the risks associated with shortening the duration of pregnancy by induction. These include gestational age of 41 completed weeks or more, Pre-labor Rupture of Amniotic Membranes (PROM), hypertensive disorders, maternal medical complications, fetal death, fetal growth restriction, chorioamnionitis, multiple pregnancy, vaginal bleeding and other complications.

Fetal health surveillance should include a non-stress test and measurement of amniotic fluid volume every 3 to 4 days in post term pregnancies. Sweeping membranes may be offered to women at 38 to 41 week’s gestation to potentially avoid post term pregnancy and promote spontaneous labour. Fetal membranes rupture prior to the onset of labour for reasons that are not well understood in approximately 8% of term pregnancies. It is important to confirm that PROM has occurred. It is estimated that 80% of women with PROM at term will begin to labour spontaneously within 12 hours, and 95% within 24 hours. PROM complicates approximately one-third of preterm labours (less than 37 week’s gestation). Hypertensive Disorders of Pregnancy (HDP) are a primary cause of maternal and perinatal mortality and morbidity  throughout the world. When induced for HDP, 27.3% were delivered by caesarean section, compared to 15.1% [3] among women induced for non-medical indications. PPH following induction or augmentation were reported to be 7.8% and 8.3% [3].

As per SOGC guidelines women should be offered induction of labour between 41+0 and 42+0 weeks as this intervention may reduce perinatal mortality and meconium aspiration syndrome without increasing the Caesarean section rate. (I-A) [4]. Women who chose to delay induction > 41+0 weeks should undergo twice-weekly assessment for fetal well-being. (I-A). It is not possible in Indian women from the lower socio-economic strata to come twice weekly for tests of fetal wellbeing. There are some local problems in India. If a woman comes with backache or tightening of abdomen at around her EDD, people expect that we admit the woman. The poverty of these people is such that they cannot go home and make a second trip to hospital. Three to four people accompany the woman coming from a village to help in any eventuality should need arise.

 Misoprostol can be considered a safe and effective agent for labour induction with intact membranes and on an inpatient basis. (I-A) Successful induction is defined as a vaginal delivery within 24 to 48 hours of induction of labour. Induction of labour is the artificial initiation of labour before its spontaneous onset to deliver the feto-placental unit. The rate reached a high of 23.7% in 2001-2002, decreased slightly to 21.8% in 2004-2005, and has since remained steady [4]. Perinatal Health Registry reveals a similar trend and rate, with post-term pregnancies (> 41+0 weeks) representing 34%, the largest group, of the total inductions [4]. SOGC considers induction of labour, the initiation of contractions in a pregnant woman who is not in labour to help her achieve a vaginal birth within 24 to 48 hours, as high priority in preeclampsia ≥ 37 weeks , significant maternal disease not responding to treatment, significant but stable antepartum hemorrhage, chorioamnionitis, suspected fetal compromise, term pre-labour rupture of membranes with maternal GBS colonization , logistical problems (history of rapid labour, distance to hospital).The author feels happy that SOGC made a mention of logistical problems, as an indication.

Bishop score of > 6 is predictive of a successful vaginal delivery. There is evidence that routine sweeping (stripping) of membranes promotes the onset of labour and that this simple technique decreases induction rates. It is believed that the technique results in an increase of local production of prostaglandins. A 2010 Cochrane review [5] concluded that vaginal misoprostol was also superior to other induction agents (vaginal prostaglandin, intracervical prostaglandin, and oxytocin), with less epidural use and fewer failures to achieve vaginal delivery within 24 hours, but more tachysystole with FHR changes. PGE1 and PGE2 both reduce CS rates even with an unfavorable cervix. The oral and vaginal routes have a similar reduction of CS rates. The oral route needs more oxytocin stimulation, but the vaginal route will have more tachysystole. All doses of misoprostol can cause uterine tachysystole.

A recent study in France in 2016, regarding labour induction practices, surveyed 94 maternity units, observed that in only 3 units  misoprostol was being used for IOL. Calls for the need for guidelines in their country [6].

2.       Material and Methods

During 8 months from Jan-Aug 2006, 1000 cases of labour induced with intravaginal PGE1, were studied and a critical analysis of the caesarean rate, perinatal mortality, perinatal survival, induction - delivery interval and complications like PPH, abruption, pyrexia and maternal deaths is presented 

The results for various indications are presented separately as it provides clarity. Observations (tables 1-6)

3.       Material, Observations

C. Section rate in1000 deliveries is 11.9%. C-Section rate in this study is 11.5% (past EDD, TG, PIH & PROM = 99/857). In the very high risk obstetric patients (Eclampsia& Abruption N=109) it is 18% in this study. The number of deliveries after 37wks is 777/1000, the remaining being preterm.

6.                   Maternal Deaths in Two Cases

6.1.              Case -1: Unbooked primi with term gestation (live fetus) admitted with antepartum eclampsia, 4 convulsions, was irritable, semiconscious with pyrexia, (1050F) B.P. 170/120, urine protein 3+. Stabilized with MgSo4, Nifedipine, Paracetamol, Mannitol. Labour induced with PGE1 25mg x 2doses. Had vaginal delivery 8 hrs after induction. She continued to be irritable, died 8 hrs after delivery due to cerebral haemorrhage.

6.2.              Case -2: G2P1L1 induced with PGE1, 25m gms 4 doses 3rd hrly. Delivered an alive 3.0kgs baby. Had atonic PPH, shock, DIC one and a half hours after delivery. Expired 10 hrs after delivery despite resuscitative measures with 6 units of blood and 6 units FFP.

7.                   250 Cases of Pregnancies Past EDD-Induction with PGE 1

7.1.              Aim of the Study

To study the efficacy of vaginal PGE1 for Induction of Labour (IOL) in pregnancies past EDD in terms of number of vaginal deliveries, induction delivery interval, perinatal outcome and complications.

7.2.              Material and Methods

Pregnancies 250, past their EDD were induced with 25 mcg. vaginal misoprostol over a period of eight months in the year 2006 from January to August at Modern Government Maternity Hospital, Osmania Medical College. There were 166 booked cases (66.4%). All booked cases had at least one scan at 18 to 20 weeks gestational age, apart from one pre-induction scan for confirmation of gestational age, fetal wellbeing and adequacy of liquor.

Bishop score was less than 6 in 204/250, 81.6% of cases. And more than 6 in 46/250, 18.4%. Labour induction was done with 25 mcg. PGE1, placed intravaginally, the number of doses varying from one to four at intervals of three hours. Oxytocin and artificial rupture of membranes (ARM) were used for augmentation of labour if needed once the woman sets into active labour. Oxytocin was used with a gap of 3 hours after the last dose of PGE1.

7.3. Criteria for Classification as Past EDD

1.       Expected Date of Delivery (EDD) was calculated based on the LMP when the woman was sure of her dates.

2.       In all other cases scan EDD was considered.

3.       Out of 250, 72.4% (181) were past EDD as per LMP.

4.       As per Ultrasonography (USG), 69 out of 250, 27.6% were past dates.

7.4.  250 Cases of Pregnancies Past EDD-Induction with PGE1 (tables 8-13)

8.       Ultrasonography for confirmation of gestational age.

In 29 unbooked cases who had no prior USG the pre-induction scan was the only one. A pre-induction scan was done in all the cases.

8.4.              Perinatal Outcome: Average birth weight in our study was 2.88 kgs. The perinatal survival was 97.2%. Seven cases in this study had perinatal deaths. One of these had major congenital anomaly. The corrected perinatal mortality was 2.4% (6/250).

8.5.  Complications

·         One case out of 250 had abruption. Placenta was found to be one third separated after delivery.

·         There were no cases of rupture uterus, hyperstimulation, post-partum hemorrhage.

8.6.              Conclusions: 250 Cases of Pregnancies Past EDD-Induction with PGE1

In conclusion induction with 25mcg of prostaglandin E1 in pregnancy past EDD is safe, cost effective, efficient, with less complications as exemplified by our study.

9.                   Labour Induction with Misoprostol (PGE1) in Preeclampsia

8.1. Aim: 210 Cases of PIH requiring labour induction managed at GMH, Nayapul using PGE1 from Jan 2006 to Aug 2006 to evaluate the efficiency and safety of low dose PGE1, 25 ug 4th hourly. ACOG approved low dose 25 ug, vaginally 4th hrly dose. 6 doses. Parity, PIH severity, antihypertensive used, no. of doses of PGE1, induction delivery interval, labour outcome, perinatal & maternal morbidity and mortality were analyzed. (tables 14-26)

8.2.              Conclusion: Even in high risk cases with unresponsive Cervix, PGE1 is safe and can be used. We had a vaginal delivery rate of 87% and a PNMR 3.8%, NICU admission was needed in 4.7%. Mild PPH occurred in two cases. There was no hyperstimulation causing perinatal mortality. PGE1 is a promising, highly effective, well tolerated inexpensive and convenient agent for labour induction.

9.                   25 Micrograms PGE1 Its Efficacy in Induction at Term

9.1.              Aim: The response to intra-vaginal 25µg PGE1, 3 - 4 hourly for induction of labour in 200 women at term managed at Government maternity hospital, Nayapul, Hyderabad from January to August 2006 is presented in terms of 1) Vaginal delivery rate, 2) Caesarean section rate, 3) Induction - delivery interval, 4) Perinatal outcome and 5) Complications.

9.2.              Material and Methods: Material - 200 women at term, drug - intravaginal 25 µg PGE1, 3-4 hourly, up to a maximum of 3 doses in one day.

9.3.              Indications for Induction

·         152 women (76%) were admitted in prodromal labour.

·         38 women (19%) were induced on their expected date.

·         Other reasons were: Oligohydramnios - 4 (2%), IUGR - 6 (3%)

9.4.  Bishop Score:In our study, 1.85% of women had a bishop score of <6. 2.15% of women had a score of > 6.

ACOG Criteria for Gestational Dating :

Fetal heart rate Documented for 20 weeks with a fetoscope or 30 weeks with a doppler evaluation. Pregnancy test It has been 36 weeks since a positive serum or urine HCG pregnancy test, performed by a reliable laboratory, Ultra-sonography* Ultrasound measurement of the crown rump length, obtained between 6 & 12 weeks, indicates gestation of at least 39 weeks. 2. *Scan between 13 & 20 weeks confirms the clinical history and physical examination gestational age of at least 39 weeks. (tables 27- 29)

·         38 women (21%) delivered vaginally within 6 hours.

·         95 women (53%) delivered vaginally within 12 hours.

·         147 women (83%) delivered vaginally within 24 hours

9.5.              Perinatal Outcome: Perinatal mortality rate was 2%. There were four neonatal deaths - three after vaginal delivery and one after LSCS.

Case 1: Primigravida with term gestation (TG) with induction - delivery interval of 11 hrs. MSL was present. Delivered a 2.5 Kgs baby with low APGAR.

Case 2: Primigravida with term gestation with induction - delivery interval of 14 hrs., outlet forceps delivery of a 3.1 kgs baby with low APGAR.

Case 3: Primigravida with TG with I-D interval of 32 hrs. Outlet forceps delivery of a deeply asphyxiated baby of wt. 2.5 kgs with cord once tightly round the neck.

Case 4: Primi with TG. Emergency LSCS was done for fetal distress. Delivered a deeply asphyxiated baby of weight 2.75 kgs.

9.6.  Complication: Three cases had PPH (around 600-700 ml). None of them needed blood transfusion. (table 30)

9.7.              Conclusions: With a vaginal delivery rate of 89%, LSCS rate of 11%, 83% vaginal delivery rate within 24hrs and no significant complications, we conclude that 25µg PGE1 is an efficient agent for cervical ripening and labour induction at term.

10.                Prelabour Rupture of Membranes (PROM), Induction of Labour with PGE1 -170 Cases

10.1.           Aim: In this study we present 170 cases of PROM induced with intravaginal 25 mcg PGE1 third hourly, at the Institute of Obstetrics and Gynecology G.M.H, Nayapul, Hyderabad during a period of eight months, between Jan 2006 - Aug.2006

10.2.           Material and Methods: Labour was induced in 170 cases of PROM with unfavorable cervix with 25 mcg of PGE1 along with syntocinon acceleration in needed cases. Preterm PROM was- 31/170 - 18% and term PROM were 139/170 - 82%. Primes were 99/170 58.23%, Mullites - 71/170 = 41.77%. Un booked cases were 96 - 56%, booked cases were 74 - 44%. Bishop’s score was less than 6 in 95.3%, more than 6 in 4.7%. (Tables 31- 38)

10.3.           Conclusion: PGE1 is effective for cervical ripening and inducing labour in PROM cases as seen in our study with 100% perinatal survival in term PROM and LSCS rate of 11%. In our study we did not have PPH or hyperstimulation. Hence low dose PGE1 is efficient & cost effective as an inducing agent. 98.6% of patients delivered within 24 hrs vaginally.

11.                Induction of Labour with PGE1 in - 60 High Risk Cases of Eclampsia and Severe Pre-Eclampsia on Magnesium Sulfate JAN 2006 to AUG 2006

11.1.           Aim: To ascertain the safety and efficacy of vaginal PGE1 for induction in eclampsia. We have efficient antihypertensives and anticonvulsants, search is for an efficient labour inducing agent. WHO guidelines recommend using misoprostol for induction of labour in highly selected situations such as severe preeclampsia or eclampsia when the cervix is unfavorable and safe C-section is not immediately available or the fetus is too premature to survive. Earlier the delivery better it is for the mother and the fetus. (figure 1)

Monitoring of FHR & Uterine activity ½ hr of placement of the tablet (peak levels at 46 minutes). Dosage repeated if required at 4-6 hrs intervals. Oxytocin started if required 4-6 hrs of the last dose. Tocolytics kept ready (Terbutaline, Ritodrine, Nitroglycerine). Backup for C-section, blood transfusion and neonatologist kept ready. (tables 39-44, figure-2)

11.2.           Maternal Death: Unbooked primi at term gestation (live fetus) admitted with antepartum eclampsia, APE, had four convulsions, was irritable, semiconscious with pyrexia (105°F) B.P. 170/120 mm of Hg., proteinuria -3+. Stabilized with MgSO4, Nifedipine, Paracetamol, Mannitol. Labour induced with PGE1 25mg x 2 doses. Delivered vaginally 8 hrs of induction continued to be irritable, died 8 hrs later due to cerebral hemorrhage.

11.3.           Conclusion: Safe, Ideal inducing agent even in Eclampsia, with total vaginal delivery rate of 49/60 (82%), induction delivery < 24 hrs in 37/49 - (76%). Perinatal survival with birth wt.1.6 kg and > 26/32 (81%).

12.    Discussion

Labour inductions have increased steadily worldwide, with overall rates in many countries now exceeding 20% of all births. The network meta-analysis [7] finds that misoprostol may be the best prostaglandin for labour induction. Titrated low dose oral solution seems to be the safest in terms of risk of caesarean section, while vaginal misoprostol tablets (≥ 50 μg) are the most effective in achieving vaginal delivery within 24 hours of induction [8].  

Oral misoprostol for the induction of labour is safer than vaginal misoprostol and has the lowest rate of caesarean section. Oral misoprostol 20-25 mcg is as effective as vaginal misoprostol. Suggested to use 20-25 mcg oral solution of misoprostol [9]. It is only recently that commercially available 25-mcg tablets have become available (Cipla, India; Azanta A/S, Denmark), but these are not yet widely available. We have requested Cipla to provide 25 mcg. tab. and they have promptly complied with our request, way back in 2006. With oral misoprostol sustained uterine activity is achieved in 90 minutes and the duration of action is approximately 2 hours.

Misoprostol is absorbed faster orally than vaginally, with higher serum peak level, but vaginally absorbed serum levels are more prolonged. Its oral use may be convenient but high doses could cause uterine hyperstimulation and uterine rupture. Vaginal use of lower doses may cause less hyperstimulation. Vaginal misoprostol is associated with locally mediated effects [10]. Even if fetal distress or uterine hyperstimulation is observed, the vaginal tablet can be removed if still undissolved.

Misoprostol for induction of labor in women with severe preeclampsia at or near-term N= 56,  vaginal delivery was achieved in 69.6% in the study group Misoprostol when given intravaginally in 50ìg 4-hourly dosing regimen is an effective agent for ripening the cervix in this group of women [11].  

Our caesarean rate of 11.9% in 1000 labour inductions is an exemplary achievement. We say this as it includes abruption and eclampsia cases also. The c. section rate without these two conditions was 11.5% [ 99/857]. Hence we recommend 25 mcg. vaginal misoprostol for labour induction. Once a decision is made to induce labour, we would do sweeping of the membranes after the pre induction USG for fetal wellbeing . Some women would set into spontaneous labour. Induction with misoprostol 25 mcg. vaginal, would start early the next day. Sweeping of the membranes when it could be done prior to medical induction, may improve the success rates. Once the Bishop score improves, when inserting the next dose of vaginal misoprostol we proceed to do some degree of sweeping of the membranes careful not to provoke excessive show.

Vaginal misoprostol is a boon for cervical ripening to improve Bishop score. Especially in the very high risk obstetric cases, eclampsia and placental abruption where early delivery would save maternal lives. The impact of prostaglandin induction in reducing the c.section rates need to be assessed.

13.    Conclusion: Misoprostol 25 mcg. vaginal placement to ripen the cervix and induce labour at term is an excellent method.

14.    Conflict of Interest: None.


Figure 1: Type of eclampsia, Induction with PGE1 in 60 cases.



Figure 2: Number of doses in relation to gestational age.


Indication

Number

Percent %

Pregnancy past dates

250

25

PIH

210

21

Term gestation

200

20

PROM

170

17

Eclampsia

60

6

Abruption

49

4.9

Cong. Fetal anomalies

27

2.7

Multi fetal gestation

6

0.6

Dextrocardia

1

0.1

Extra

27

2.7

 

Table 1: Indications for IOL in 1000 cases.

 

Indication

GA

No.

Vag

LSCS No.

LSCS %

PNM %

Del

Past EDD

Term

250

222

28

11

2.4

Term Gest.

Term

200

178

22

11

2

Preeclampsia

>37wks-143

210

183

27

13

3.8

<37wks-67

PROM

>37wks-139

170

151

19

11

Nil

<37wks-31

4

Eclampsia

>37wks-9

60

49

11

18

47

33-36wks-21

29-32wks-15

22-28wks-15

Abruptio placenta

>36wks-9

49

40

9

18

89.79

32-36wks-16

28-32wks-11

20-28wks-13

Fetal anomalies

 

27

   

Nil

 

Extra

 

27

 

3

11

Nil

 

Table 2: C. Section & PNM Rates in PGE1 Induced Cases.

 

 

Indication

GA

No.

<12hrs

<24hrs

24-48 hrs

%

%

%

Past EDD

Term

250

61

93

 

Term Gest.

Term

200

53

83

 

Preeclampsia

>37wks-143

210

58

89

 

<37wks-67

PROM

>37wks-139

170

92

99

 

<37wks-31

Eclampsia

>37wks-9

60

-

76

24

33-36wks-21

29-32wks-15

22-28wks-15

Abruptio placenta

>36wks-9

49

92

96

 

32-36wks-16

28-32wks-11

20-28wks-13

Fetal anomalies

 

27

 

47

86

Extra

 

27

 

 

 

 

Table 3: Induction Delivery Interval.

 

Indication-No. LSCS

FD

Failure to

Progress

CPD

Oligoamnios

Un-D

breech

Precious preg.

Abruption

Past EDD- 28/250

18

6

2

2

     

Term Gest. -22/200

11

7

2

 

1

1

 

PIH-27/210

13

12

1

     

1

PROM- 19/170

5

11

3

       

Eclampsia-11/60

5

5

1

       

Abruption-9/49

 

9

         

Fetal Anom. -27 - Nil

             

Extra-3/27

1

2

         

TOTAL

53

52

9

2

1

1

1

 

Table 4: Indications for C. Sections 119/1000 - 11.9%.

C-Sections 119/1000 - 11.9%.

 

Indications

No.-119

% of total deliveries

 

11.90%

Fetal Distress

53

5.3

Failure to Progress

52

5.2

CPD

9

0.9

Oligoamnios

2

0.2

Un-Diagnosed

1

0.1

Breech Presentation

Precious Preganancy

1

0.1

Abruption

1

0.1

 

Table 5: Indications for caesarean delivery in PGE1.

 induced labours N=119/1000.

 

Authors

Place,Journal

No.cases/ group1 &2

Total no. Indications

Vag.Del. %

LSCS %

PNMR %

Conclusion

1.Gupta N, Mishra SL, Jain Shradha

Ajmer JOGI 2006

Gp A=100 PGE2 gel Gp B+100 Vag. Miso

Total=200 Past dates,HDP, Elective term, IUFD,PROM,fetal anomaly

68 +6=74  86 +2=88

26        12

1                    2

Miso more effective than Dinoprostone gel

2. Kaima A. Frass,Alia A. 2009-2010

Yemen Saudi MedJ 2011

n=56 Miso 50μg 4-hourly vaginally.

Total=56 severe preeclampsia 56 controls 57

69.60%

30.3

1.8

 Miso 50μg 4-hourly could reduce the cesarean section rate in this population.

3. Rakhi Rai, Sulabha Joshi

Nagpur PJMS 1/1/2017

N=100 Misoprostol 25 mcg x 6 hours, PGE2 gel group2 N=100

 Total=200 Postdated, PIH, IUGR,GDM Oligohydramnios

86%    75%

 

 

Misoprostol is better, more cost-effective

4. Masom eh Rezaie1, , Fariba 2013-2014

Iran www.jcdr.net, 2016

N=31 -vag.25 mcg. Miso N=22 oral 100 mcg miso N=33 oral 50 mcg.miso

31+22+33= 86                        41 weeks, post-term pregnant women

 

N1-25    N2-10   N3-15

1.7, 5.2, 15.0   (NICU admission)

oral misoprostol 100μg is more useful. Vag. miso- NICU=less

5. Aqueela Ayaz1, Shazia Saeed2 2004-2005

Pakistan MJMS 16(1): 35

N=44-Oral 50mcg.Miso N=44-Vaginal Miso

N=88 post date women

84%     77% (Within 24 hrs.)

7%       4%

NICU admissi 12% vs. 5%; p>0.05 PNM gp2=2%

50mg oral misoprostol has the potential to induce labor as safely and effectively as its vaginal route.

6. Bushra Iftikhar, Shehla M Baqai* 2006

Rawalpindi PakistanPak Armed Forces Med J 2016;

N1= 30, group A 50microg of Misoprostol N2-30, GroupB Prostaglandin E2

30+30 Total=60 Postdates,PE,GDM,PROM

80%     70%

 

 

Misoprostol is an effective agent

7.Singh Pushpa. Sweta, Indu 2014

PGIMER, New Delhi JOGI 2014

1.intracervical dinoprostone, 2.50 mcg. X4hrly misoprostol

Group 1- 192 Group2- 137 N=329 Post-date,PIH, GDM,

1. 55.21 2. 65.69

43.23 32.85

NICU admission was 22.9 % And 22.6% Low Apgar score at 5 -min 4.7% & 1.5 %

misoprostol was more efficacious than dinoprostone gel for labor induction

7. Jindal Promila Avasthi Kumkum

Punjab, India JOGI 2011

1.misoprostol 50 mcg. Orally N=51 2.vaginally, four hourly, N=52

N=51 N=52 Total 103 HDP IUGR

74.51     92.15

 25.49 vs. 9.62%,

 

Vaginal route of misoprostol is more effective than oral

 8. Pratibha D. Deepa

Hyderabad 2006

25 mcg. Miso, vagina lx 4hrly

N=250 Past dates

222=88.8 %

28= 11.2%

2.40%

High vaginal del. Rate One had abruption.

+ Swathi G, Padmaja A

Hyderabad2006

Do

N = 200 Induction at term

89%

11%

2.00%

 

+ Usha V.

Do

25 & 50 some cases

N =210 Preeclampsia Mild -178 Severe -32

182 = 86.6%

28 = 13.3%

3.8% Excluding Less than 1.5 kgs

Early severe Preeclampsia cause of PNMR

+ Varada

Do

25 Miso vag. 4 hrly

N= 170,PROM Term-139, preterm-31

89%

11%

4.00%

 

+Malati P

Do

Miso,25,50,100 mcg depending on gest. Age. 4 hrly

N=60 induced/119 Eclampsia, Severe preeclampsia

49 = 82%

11 = 18%

 

 

+ Nagasree MGS

 

PGE1 VAg. 4 hrs

N=49/116 Abruptio placenta

40 = 81.63%

9 = 18.36%

 

 

 

Table 6: Comparative studies with conclusions.

Complication

No

%

Placental abruption

6

0.6

PPH

4

0.4

Maternal Deaths

2

0.2

 

Table 7: Labour induction with PGE1 Complications in 1000 cases.

 

Number of scans

Number of pts.

%

No prior usg.

29

11.6

1

106

42.4

2

103

41,2

3

10

4

4

2

0.8

 

Table 8: Number of scans the woman had prior to admission.

In 29 unbooked cases who had no prior USG the pre-induction scan was the only one. A pre-induction scan was done in all the cases.

 

Number of Doses

Primi

G2

G3

G4

Total

%

1

48

26

13

2

89

35.6

2

51

36

19

2

108

43.2

3

27

13

2

1

43

17.2

4

8

2

0

0

10

4

Total

134

77

34

5

250

 

%

53.6

30.8

13.6

 

 

 

 

Table 9: Dose parity wise distribution of cases N=250.

 

Number of Doses

Number of cases

Delivered

Within 12 hrs.

%

Delivered

Within 24 hrs.

%

1

83

71

85.54

82

98.79

2

98

61

62.24

92

93.87

3

35

3

8.57

29

82.85

4

6

-

-

4

66.6

Total

 

222

135

60.81

207

93.24

 

Table 10: Induction delivery interval - 222.

135 out of 222 = 60.81% delivered within 12 hours.

207 out of 222 = 93.24% delivered within 24 hours.

 

Mode of delivery

Number of cases

%

Vaginal

222

88.8

Caesarean

28

11.2

 

Table 11: Route of delivery.

 

Indication

Number

Fetal distress

18

Failed induction

4

Failure to progress

2

Cephalopelvic

disproportion

2

PROM, oligoamines

2

 

Table 12: Indication for LSCS.

 

parity

No Doses

Ind-del

ARM/Sp.rupture

Ind-ARM interval

Mode of delivery

Risk factors

Other findings

outcome

 

Interval

G1

2

10

ARM-MSL

9

LSCS

   

Expired in nursery

G1

2

20

ARM-Clear

13

Sp.vaginal.del

 

Hind waters-MSL

Expired imm. After birth

G1

1

7

Spont.rupture-clear

4

Sp.vag.del

 

Hindwaters-msl

Expired in nursery

G1

2

27

ARM-MSL

24

Sp.vag.del

   

Expired in NICU

G2

2

13

ARM -MSL

10

Vag. del

Abruption

   

G2

2

11

ARM-MSL

10

LSCS

AFI-6

 

Expired nursery

 

Table 13: Perinatal mortality in six cases.

 

Inclusion Criteria

Exclusion Criteria

Single Fetus

Non-vertex

Vertex Presentation

Previous LSCS

CPD Ruled Out

 

No disease of Lung, Liver, Kidney

Multiple pregnancies

No Glaucoma

Uterine Anomalies

No Epilepsy

Fetal Distress

 

Table 14: Selection Criteria.

 

<19 Yrs

7%

20-25 Yrs

78%

26-30 Yrs

14%

>30 Yrs

0%

 

Table 15: Age distribution of women.

 

Primi

136

64%

G2

49

23%

G3

15

7.10%

G4

7

3.30%

G5

2

0.95%

G6

1

0.47%

 

Table 16: Parity- Wise Distribution.

 

Weeks of Gestation

%

<30 Wks

6

30-36 Wks

27.33

>37 Wks

66.6

 

Table 17: Term of gestation when IOL was planned in Preeclampsia .

 

Bishop Score

No. cases Total-210

%

<6

173

82.66

>6

37

17.33

 

Table 18: Bishops Score in 210 PreEclampsia.

 

Mild PIH

178 cases

84.76%

Severe PIH

32 cases

15.23%

 

Table 19: Severity of PIH (preeclampsia) No.

 

Drug

No cases total 210

1. Cap. Nifedepine

210

2. Nifedepine+ Methyl Dopa

12

3. Labetalol+ Alpha Methyl dopa+Nifidepine

1

4. Mag. SO4

9

 

Table 20: Drugs used to control hypertension.

 

Parity

0-6 hrs

7-12 hrs

13-18 hrs

19-24 hrs

25-36 hrs

37-48 hrs

Primi

23

34

25

16

8

7

G2

13

18

5

4

2

2

G3

6

7

1

 

1

 

G4

2

1

3

 

1

 

G5

 

1

1

 

 

 

G6

 

1

 

 

 

 

 

Table 21: Induction Delivery Interval in relation to parity.

Induction Delivery Interval

<12 hrs 58% cases delivered, <24 hrs 89% cases delivered.

 

Mode of Delivery

Total No

%

Vaginal

182

86.6

Spontaneous

122

 

Forceps

50

 

Vacuum

10

 

Caesarean Section

28

13.3

 

Table 22: Mode of Delivery in 210 Preeclampsia

 

Indication

No.

% of 28

Failed Induction

14

50

Fetal Distress

10

35.7

Abruption

1

3.55

Deep Tr. Arrest

1

3.55

Imminent Eclampsia

2

7.14

 

Table 23: Indications for Caesarean Section in 28 (Primes 23 + Multis 5).

 

Dose No

Primi

G2

G3

G4

G5

G6

1

33

20

5

3

1

1

2

45

17

7

4

1

 

3

25

7

3

 

 

 

4

8

 

 

 

 

 

5

1

 

 

 

 

 

6

1

 

 

 

 

 

 

Table 24: Parity wise Doses.

 

Perinatal Outcome

No.Cases

%

Perinatal Survival

195

92.85%

NICU Admissions

10

4.76%

Perinatal Mortality

15

7.15%

Less than 1.5 kgs

7/15

 

Corrected Perinatal Mortality

8/15

3.8

 

Table 25: Perinatal Outcome, Total No of cases 210.

 

Complication

No.

Pyrexia

8

Eclampsia

2

Imminent

9

Abruption

1

PPH

2

Severe anaemia

2

Wound gaping

2

 

Table 26: Complications in 210 Preeclampsia IOL with PGE1.

 

PGE1

G1

G2

G3

G4

TOTAL

%

VAG.DEL.

LSCS

NO OF DOSES

1

59

22

11

-

92

46%

88

4

2

49

13

3

1

66

33%

58

8

3

28

7

1

-

36

18%

28

8

4

4

1

1

-

6

3%

4

2

TOTAL

140

43

16

1

200

 

178

22

%

70

21.5

8

0.5

 

100

89

11

 

Table 27: Induction at term with PGE1 25mcg. - 200 cases Number of doses needed in relation to gravida status.

We have not done admission test for any of the cases.

We have used intermittent auscultation with feto-scope for monitoring.

 

NO OF DOSES

< 6HRS

6-12 HRS

12-18 HRS

18-24 HRS

24-48 HRS

>48 HRS

1

38

34

8

8

 -

 -

2

 -

22

14

10

12

 -

3

 -

1

6

5

13

3

4

 -

 -

 -

1

3

 -

 

Table 28: Induction Delivery Interval 178 Cases.

 

No. Women

%

Hours

38

21

6

95

53

12

147

83

24

 

Table29: Induction delivery interval.

 

Birth wt. (Kgs)

2.1-2.5

2.6-3

3.1-3.5

3.6-4

4.1-4.5

 No.

53

104

37

5

1

 %

26.5

52%

18.50%

 

 

 

Table 30: Birth Weights in 200 cases.

 

Gestational period

No.

%

Preterm PROM

31

18

Term PROM

139

82

 

Table 31: Number of cases in relation to term of gestation.

 

Weeks of gestation

No

. %

Less than 28 weeks

3

1.76

28 to 32 wks

9

5.29

32 to 36 wks

19

11.17

37 to 40 wks

139

81.76

 

Table 32: Weeks of gestation, No. of cases.

 

Gravida

Total No

Vaginal deliveries

LSCS no

Primi

99

83

16

G2

45

44

1

G3

22

21

1

G4

4

3

1

Total %

170

151=89%

19=11%

 

Table 33: PROM 170 Vaginal / Abdominal delivery in relation to Gravida status.

Vaginal deliveries in 151 = 89% and LSCS in 19 = 11%

 

No. Doses

Primi

G2

G3

G4

Total

1

52

29

10

3

94

2

25

10

6

-

41

3

6

5

5

-

16

Total

83

44

21

3

151

 

Table 34: Number of doses of PGE1 25 mcg. In relation to parity.

 

Number of doses 25 mcg.

No. of cases

%

1

94

62

2

41

27

3

16

11

 

Table 35: Number of doses needed for vaginal delivery in 151.

With one dose of 25 mcg of PGE1 64.5% of patients responded with syntocinon acceleration in needed cases.

 

PGE1 Doses 25 mcg.

12 hrs.

24 hrs.

More than 24 hrs.

1

92

3

1

2

35

4

1

3

12

3

-

Total %

139 -92%

10

2

 

Table 36: Prom Pge1 Induction Delivery Interval in Vaginal Deliveries in 151.

 

Indications for LSCS

No.

Fetal distress

5

Failure to progress

11

Big baby with CPD

3

 

Table 37: Indications for LSCS

Among 19 cases of L.S.C.S. 16 were primigravidas

 

Details

No

Survival %

Term PROM

139

100

Preterm PROM

31

77.42

IUD at admission*

1

 

Neonatal deaths**

6

 

Total 170 - PNM

7

4.11

NICU admissions

19

11%

 

Table 38: Perinatal outcomes in 170

 

Primes

G2

(A1/L1)

G3

(A2/L2)

G4

P3/L3)

44

73%

8

13%

7

12%

1

2%

 

Table 39: Parity.

 

G. Age

Antepartum

Eclampsia 33

%

At > 28 wks

29/33

88%

< 28 wks

4/33

12%

 

Table 40: Time of onset of Eclampsia.

 

Gestational age

No.

Vaginal Del.-49

LSCS -11

Less than 30 weeks

23

23

 

More than 30 wks.

37

26

11

Foetal distress

 

 

5

Failure to progress

 

 

6

 

Table 41: Mode of delivery N=60, In relation to gestational age.

Vaginal delivery -49=82%, LSCS - 11 =18%

 

Vaginal delivery.

Birth Wt.

No.

Survival

 

%

49/60

1.5 kg &<

28

5

18

 

 

1.6 kg &>

21

16

76

C-section

1.5 kg &<

Nil

 

 

11/60

1.6 kg &>

11

10

90

Total Perinatal survival

 

60

31

52

 

Table 42: Perinatal outcome in vaginal delivery and LSCS in eclampsia and severe preeclampsia.

 

Induction delivery interval

No.

%

Less than 24 hrs.

37

76

More than 24 hrs.

12

24

 

Table 43: Induction delivery interval in vaginal deliveries -49.

 

Sl.no.

Complication

No.

%

1

Pyrexia (100-102°F)

4

7

2

Abruption

blood transfusion

4

2

7

3

Admitted with anemia

4

7

4

Maternal death

Cerebral Hemorrhage

1

1.66

Table 44: Complications and Maternal Mortality in 60.

 

 

1.       World Health Organization (2011) How recommendations for induction of labour: Evidence.

2.       WHO (2010) Global Survey on Maternal and Perinatal Health. Induction of labour data. Geneva, World health Organization.

3.       Reproductive Care Program of Nova Scotia (2012) Induction of Labour in Nova Scotia - Report from the Provincial Quality Assessment Review. Reproductive Care Program of Nova Scotia 73. 

4.       Induction of Labour (2013) SOGC CLINICAL PRACTICE 107: 1-18.

5.       Cochrane review (2010).

6.       Blanc-Petitiean P, Salome M, Dupont C, Gaudineau A, Perotte F, et al. (2018) Labour induction practices in France A population-based declarative survey in 94 maternity units. J Gynaecol Obstet Hum Reprod 47: 57-62.

7.       Alfirevic Z, Keeney E, Dowswell T, Welton NJ, Dias S, et al. (2015) Labour induction with prostaglandins: a systematic review and network meta-analysis.

8.       Weeks AD, Navaratnam K, Alfirevic Z (2017) Simplifying oral misoprostol protocols for the induction of labour. BJOG 124: 1642-1645.

9.       Cochrane Collaboration (2014) Comparing Multiple Interventions Methods Group. Comparing multiple interventions in Cochrane reviews. 

10.    Wannchar L (2005) Misoprostol low dose labour induction at term. Archives WHO International.

11.    Frass KA, Shuaib AA, Al-Harazi AH (2011) Misoprostol for induction of labor in women with severe preeclampsia at or near term. Saudi Med J 32: 679-684.

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