Untitled Document

ORIGINAL ARTICLE

Year : 2020  |  Volume : 3 |  Issue : 1 |  Page : 8-13

DOI: https://doi.org/10.46319/RJMAHS.2020.v03i01.003

 

Comparative study of pge2 gel versus Foleys catheter for induction of labour in women with unfavourable cervix
S Samra1, B S Dhananjaya2*
1Post graduate, 2 Professor & HOD, Department of Obstetrics &Gynecology, Sri Siddhartha Medical College Research Centre, SSAHE, Tumakuru.
*Corresponding author:
Dr. B S Dhananjaya, Professor & HOD, Department of Obstetrics & Gynecology, Sri Siddhartha Medical College Research Centre, Tumakuru, Karnataka. India.
E-mail: drdhananjaybs@gmail.com
Abstract
Background: Labour begins with cervical ripening, a process that employs prostaglandins to soften and dilate the cervix. Prolonged labour carries increased risk of operative deliveries, maternal and fetal morbidities. The success of induced labour depends on the consistency, compliance and configuration of the cervix, which is assessed by Bishops Score. Whenever the Bishops score is less, there is a need to ripe the cervix as well as we need an agent for uterine contraction. Pharmacological methods such as prostaglandins are used widely for cervical ripening but have their side-effects and complications. Mechanical approaches such as Foley’s catheter balloon, though useful has not been very popular because of infection. Therefore, the study is to compare the safety and efficacy of intra-cervical prostaglandin E2 (PGE2) gel with Foleys catheter. Materials and Methods: The sample size was 100 and women were divided equally into group 1 (PGE2 gel) and group 2 (Foleys catheter) after fulfilling inclusion and exclusion criteria. Results: Both the groups showed a significant change in the post-induction Bishop's score; which was better with Foleys catheter than PGE2 gel group. Higher incidence of side effects noted in group 1. The induction to the delivery interval was 14.3± 2.2 hours in group 1 and 12.18±2.58 hours in group 2 (p=0.02). Augmentation of labour needed in both groups, but the duration was higher in PGE2 group. However, maximum women delivered by vaginal route. Neonatal outcomes showed no significant difference between the two groups.
Keywords: Induction of labour, PGE2 gel, Foley's catheter, unfavourable cervix
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Introduction
The goal of Obstetrics is a pregnancy with a minimally traumatised mother and a healthy infant. Labour is a process which begins with biochemical changes in connective tissue evidenced clinically by effacement, dilatation of cervix & descent of fetus.
                Time is the most crucial factor which determines the maternal and fetal outcome. Whenever pregnancy continues beyond the term, there is a risk for both the mother and the fetus. [1] Sometimes there is a need to deliver before term because of obstetric complications or risk involving the fetus.
                In these situations, there is a need for induction of labour.
                Induction of labour is defined as the initiation of uterine contractions before the spontaneous onset of labour, with or without ruptured membranes after 28 weeks of gestational age using mechanical or pharmacologic methods to generate progressive cervical dilatation and subsequent delivery. [2] When the cervix is uneffaced and undilated, labour induction will start with cervical ripening, a process which uses prostaglandins to soften and dilate the cervix.
                The unripe cervix thus remains a well-recognised obstacle to successful induction of labour.
                Over the years, several methods are used to induce labour in the setting of an unfavourable cervix to increase cervical favourability and shorten the duration of labour.
                There is always search for an induction method which is safe as well as effective. Induction methods include medical (Prostaglandins, Oxytocin), surgical (Artificial Rupture of Membranes, stripping of membranes), mechanical (Foleys catheter with or without Extra Amniotic Saline Infusion) and combined.
                There is no ideal method for induction of labour. There is a focus on Mechanical means as there are fewer side effects or complications as associated with pharmacological and surgical techniques.
                The use of a Foleys catheter inflated above the internal cervical os with or without extra amniotic saline infusion can be used as a safe, painless, low cost, reversible and non-pharmacological method of cervical ripening before induction of labour. It can be considered in areas with limited resources.
                The combination of myometrial stretching and direct cervical pressure by the balloon with stimulation of chorioamnion and decidua by saline infusion may be synergistic to promote endogenous prostaglandin production and cervical ripening and also by supplying additional mechanical force and by cytokine release.[3,4]
                A Very few studies have compared the safety and efficacy of PGE2 gel versus Foleys catheter induction in the past.  Therefore this study was carried out to compare the safety and efficacy of PGE2 gel with Foleys catheter in the induction of labour in women with an unfavourable cervix.

 

Materials and Methods
A prospective study conducted in the Department of Obstetrics and Gynecology at Sri Siddhartha Medical College, Tumakuru during the period from November 2017 to October 2019 after getting the approval from the Ethical Committee among the women admitted in the department of OBG as per the inclusion and exclusion criteria after proper counselling and after getting their consent.
Sample size calculation is done using the formula:
N= 2[ Z(1-α/2) + Z(1-β)]2×(SD)2
                            D2
Z value for 5% level of significance Z(1-α/2) = 1.96
Z value or 80% power Z(1-β) = 0.84
Standard Deviation (SD) = 6.71
Effect size (D) = 4
N= 45
Taking non response as 10%, total sample was 50 in each group. Every patient was allocated alternatively into group 1 and group 2.
Women with singleton pregnancy irrespective of parity, a cephalic presentation with intact membranes, 28 to 42 weeks of gestation, favourable pelvis, unfavourable cervix with Bishops score less than 5 were included.
Women with a previous uterine scar, history suggestive of antepartum haemorrhage, malpresentation, multiple pregnancies, contracted pelvis, uterine anomalies, PROM, non-reactive NST, severe local infection, patients in spontaneous labour, cardiopulmonary diseases, glaucoma, herpes simplex infection excluded from our study.
Informed consent taken and broad-spectrum antibiotics were started half an hour before the procedure. Patient placed in the dorsal position and vulvovaginal area cleaned with an antiseptic solution. Sims speculum was inserted into the vagina and cervix visualised. 
Group 1: Intracervical PGE2 gel (dinoprostone) 0.5mg placed and Bishop score reassessed after 6 hours; additional dose if needed, was applied.
Group 2: Using the sponge holding forceps, the Foleys catheter passed through the cervical canal above the internal os. The balloon inflated with 30ml distilled water. The speculum removed, and the catheter gently withdrawn until it rests at the level of the internal os. With the same traction, the catheter taped onto the inner aspect of the thigh. The catheter blocked by putting a knot on the catheter before taping it. The catheter left in place for 12 hours.
Fetal heart rate checked after completion of the procedure. The patient observed for uterine activity, pulse rate, blood pressure, respiratory rate and fetal heart rate.
If the catheter did not expel, it was removed after 12 hours. The vaginal examination was done when the catheter falls out or after removal at 12 hours to measure the Bishop score.
When the cervix becomes favourable, induction was started (ARM, Oxytocin or ARM+Oxytocin). The Paediatrician assessed APGAR score.

The following data was collected from each case:
Timing of application of PGE2 gel and Foleys insertion; Timing of Foleys expulsion/removal; Bishop score before PGE2 gel application and Foleys insertion; Bishop score after PGE2 gel application and Foleys expulsion/removal; the need for oxytocin augmentation, mode of delivery, induction to delivery interval, APGAR score of the baby at 1 and 5 minutes, NICU admission, Detection of maternal and fetal complications and side effects, Mother observed for postpartum pyrexia, pelvic infection & sepsis and postpartum endomyometritis.

Descriptive statistics using percentage analysis done. Students t test and Chi square test were used to compare the groups statistically. P value of <0.05 was considered statistically significant. 
Results
During the study period of 24 months, 100 subjects were included in the study and were divided into two groups of 50 each and had induction of labour by PGE2 gel application and Foleys catheter alone.
Baseline characteristics of all the subjects enrolled are shown in table 1.
Majority of women were in the age group of 21-25 years, and the mean age of mothers was 23.82±2.86. Out of the 100 subjects, maximum were literate and coming from a rural area in both the groups. 30 subjects enrolled were primigravida, and 20 were multigravidas in both groups. Maximum women had a gestational age at induction between 37-40 weeks with a mean of 38.06±2.48 weeks in both the study groups.

 

Table 1: Baseline characteristics of subjects


Parameter

Group 1

Group 2

Age (years; mean ± SD)

23.82±2.86

23.82±2.86

Literacy

  1. Literate
  2. Illiterate

 

41(82%)
9(18%)

 

35 (70%)
15 (30%)

Residence

  1. Rural
  2. Urban

 

      35 (70%)
15 (30%)

 

39 (78%)
11 (22%)

Parity

  1. Primi
  2. Multi

 

30 (60%)
20 (40%)

 

30 (60%)
20 (40%)

Gestational age (weeks±SD)

38.22±2.59

38.06±2.48

Comparison of Pre induction and post-induction Bishop score between the study groups shown in table 2 and figure 1.

 

 

Table 2: Pre induction and post induction Bishop score.


Bishop score

Group 1

Group 2

P value

  1. Pre induction (BS1)

 

  1. Post induction (BS2)

 

2.68±0.65

 

8.74±0.49

 

2.82±0.75

 

8.30±0.79

 

0.321

 

0.001

newor1

Graph 1: Comparison of pre and post-induction Bishop score between the study groups  

In the PGE2 group, 21 (42%), 24 (48%) and 5 (10%) women had pre-induction Bishops score of 2, 3 and 4 respectively with a mean of 2.68±0.65. 1 (2%), 11 (22%) and 38 (76%) women had post-induction Bishops score of 7, 8 and 9 respectively having a mean of 8.74±0.49.
In the Foleys catheter group, 19 (38%), 21 (42%) and 10 (20%) women had pre-induction Bishops score of 2, 3 and 4 respectively with a mean of 2.82±0.75. 10 (20%), 15 (30%) and 25 (50%) women had post-induction Bishops score of 7, 8 and 9 respectively having a mean of 8.30±0.79.

The various indications for induction of labour in women shown in Table 3. The most common indication was pre eclampsia constituting 34% and 38% of subjects in group 1 and 2 respectively followed by Prolonged pregnancy (32% vs 28%), intrauterine foetal demise (20% vs 16%), oligohydramnios (12% vs 10%), intrauterine growth restriction (2% vs 4%) and Diabetes mellitus (0% vs 4%).

Table 3: Indications for Induction of labour.


Indication

Group 1 No. of cases (%)

Group 2 No. of cases (%)

Pre eclampsia

17 (34%)

19 (38%)

Prolonged pregnancy

16 (32%)

14 (28%)

Intra uterine fetal demise

10 (20%)

8 (16%)

Oligohydramnios

6 (12%)

5 (10%)

Intra uterine growth restriction

1 (2%)

2 (4%)

Diabetes mellitus

0 (0%)

2 (4%)

Total

50 (100%)

50 (100%)

Outcome variables in terms of induction to delivery interval (IDI) and augmentation of labour shown in Table 4.
The IDI in PGE2 group was less than 10 hours in 2 (4%), 10-15 hours in 40 (80%) and more than 15 hours in 8 (16%) women. The mean IDI was 14.3± 2.2 hours. The IDI in Foley's group was less than 10 hours in 5 (10%), 10-15 hours in 35 (70%) and more than 15 hours in 10 (20%) women. The mean IDI was 12.18 ± 2.58 hours.
P-value was 0.02, which is statistically significant, showing that women induced by Foleys catheter had a faster induction to delivery interval than those induced by PGE2 gel.
Labour was augmented with oxytocin in 40 (80%), and 36 (72%) women and the mean duration of augmentation was 5.67± 5.57 and 3.83±1.87 hours in both the groups respectively. P-value was 0.02, which is statistically significant.

Table 4: Induction to delivery interval andAugmentation of labour.


Parameters

Group 1

Group 2

P value

Inductionto delivery interval (hours; mean±SD)

14.3± 2.2

12.18±2.58

0.02

Augmentation of labour (hours; mean±SD)

5.67± 5.57

3.83±1.87

0.02

The mode of delivery and indications for LSCS shown in table 5. Maximum women had Vaginal delivery constituting 64% vs 60%; 6% vs 10% had an operative vaginal delivery and 30% vs 30% of women had Lower segment Caesarean section in the two groups respectively for various indications with the most common indication being prolonged labour (20% vs 16%).

Table 5: Mode of delivery.


Modeof delivery
  1. Vaginal delivery
  2. Operative vaginal delivery
  3. LSCS

 

32 (64%)
3 (6%)
15 (30%)

 

30 (60%)
5 (10%)
15 (30%)

Indications for LSCS

  1. Fetal distress
  2. Prolonged labour
  3. Others

 

3 (20%)
10 (66.6%)
2 (13.3%)

 

2 (13.3%)
8 (53.3%)
5 (33.3%)

 

Side effects were compared between the two study groups in terms of fever with chills, nausea with vomiting, diarrhoea and discomfort. It is shown in table 6 and graph 2.

Table 6: Side effects


Side effects

Group 1

Group 2

Hypertonic uterine contractions

0 (0%)

0 (0%)

Fever with chills

4(8%)

0(0%)

Nausea with vomiting

3 (6%)

0(0%)

Diarrhea

3(6%)

0(0%)

Discomfort

0(0%)

2(4%)

The various maternal outcomes studied included incidence of Chorionamnionitis, Postpartum haemorrhage (PPH), maternal sepsis, sub involution, Meconium stained liquor (MSL) and Postpartum endomyometritis as depicted in Table 7.

Table 7: Maternal outcome


Maternal outcome

Group 1

Group 2

Chorioamnionitis

0(0%)

0(0%)

PPH

4 (8%)

3(6%)

Maternal Sepsis

0(0%)

0(0%)

Sub involution

0(0%)

0(0%)

MSL

7(14%)

8(16%)

Postpartum endomyometritis during follow up

0(0%)

0(0%)

The various neonatal outcomes studied included birth weight, 1 and 5 minutes APGAR score, NICU admission, neonatal sepsis and neonatal hyperbilirubinemia, as shown in Table 8.

Table 8: Neonatal outcomes


Neonatal outcomes

Group 1

Group 2

Birth weight (kgs; mean)

2.8

2.8

APGAR score

  1. 1 min
  2. 5 min

 

6.78± 2.47
7.93± 2.04

 

6.88±0.33
8.14±0.57

NICU admission

12 (24%)

10 (20%)

Neonatal sepsis

0 (0%)

0 (0%)

Neonatal hyperbilirubinemia

5 (10%)

3 (6%)

Discussion
Induction of labour refers to the adoption of any method (medical, surgical or combination thereof) to initiate uterine contractions in a quiescent uterus beyond the period of gestation maturity.
Need for inducing labour is considered when the obstetrician detects a deteriorating intrauterine fetal environment threatening fetal life and the fetus has reached adequate maturity. 
The incidence of induction of labour in clinical practice varies. In the western world, it varies between 20-30% whereas, in India, it is generally between 5-15%. [5]
In this study, PGE2 gel compared with transcervical Foleys catheter for cervical ripening and induction of labour in women with an unfavourable cervix. In our study, baseline demographic characteristics were comparable between the two study groups. Indications for Induction of Labour were prolonged pregnancy, oligohydramnios, IUFD, Preeclampsia, IUGR and Diabetes mellitus with the most frequent indication being pre-eclampsia which was similar to study by Laddad MM et al.[6]
The mean pre-induction Bishop score was 2.68±0.65 and 2.82±0.75 and mean post-induction Bishop score was 8.74±0.49 and 8.30±0.79 in the two study groups respectively. There was a significant improvement in Bishop score among both the groups with a statistically significant p-value. However, one method did not show a statistically significant advantage over the other. This is comparable with the study conducted by Jozwiak M et al and Anthony C et al. [7,8]
The induction to the delivery interval was 14.3± 2.2hours and 12.18±2.58 hours in the two groups, which showed that interval was shorter in Foley's group compared to PGE2 group. The duration of augmentation of labour was 5.67± 5.57 hours in PGE2 group and 3.83±1.87 hours in Foley's group with a p-value of 0.02 showing that augmentation was shorter in Foley's group. These observations were similar to the studies by Dewan et al. and Pennel C et al. [9,10]
In our study, the mode of delivery in maximum women was by spontaneous vaginal delivery which was in line with studies conducted by Anthony C et al.[8]
In our study, the indications for LSCS were fetal distress, prolonged labour and others which correlates well with other studies.
Side effects such as fever with chills, nausea, vomiting and diarrhoea were observed only in PGE2 group. The most noted maternal complication encountered in our study was postpartum haemorrhage not encountered in other studies. 
Neonatal outcomes observed in terms of birth weight which was 2.8kg, APGAR score at 1 and 5 minutes which was 6.78± 2.47 and 7.93± 2.04 & 6.88±0.33 and 8.14±0.57 in the two groups respectively, rate of NICU admission is 24% vs 20%, neonatal sepsis (0%) and neonatal hyperbilirubinemia 10% vs 6% in the study groups which was comparable with other studies.
Conclusion
PGE2 and Foley's catheter induction resulted in significant improvement of Bishop score in women with unfavourable cervix undergoing induction of labour. It resulted in a successful induction with maximum vaginal deliveries. The induction to the delivery interval was shorter, and fewer side effects encountered with Foley's induction than PGE2. In areas with limited resources, Foley's catheter induction is a simple, readily available, inexpensive, safe and effective method for induction of labour. 
Acknowledgements:Nil
Financial support and sponsorship:Nil
Conflict of interest:Nil
References
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