Aims: Aim of the study is to compare between dinoprostone vaginal insert alone and mechanical method along with vaginal insert for cervical ripening in primigravida women. Materials and methods: A hospital-based prospective comparative observational study. All primigravida with in Niloufer hospital for women and children in Department of Obstetrics and Gynaecology, who give informed consent for the study. This study was conducted in 300 primigravida women for a period of 2 years Results: It observed that bishops score of 3 was more prevalent in both groups (Group A - 57.33% and Group B - 42%). Most of the Group A individuals 58/150 (38.6%) did not required any augmentation method, were as 87/150 (58%) i.e. more than half of the Group B individuals required artificial rupture of membranes as an augmentation method. Moreover, most of the Group A 85/150 (56.6%) had clear amniotic fluid, were as in Group B 58/150 (38.6%) have MSL -1 followed by 34/150 (22.6%) MSL-3, and the distribution of birth weights showed birth weight of2.8 – 3 kg. Notably, more normal deliveries, better APGAR scores, less induction to delivery interval and fewer SNCU admissions were observed in Group A individuals. Conclusions: Combined application of mechanical and dinoprostone vaginal insert and dinoprostone insert may result in a shorter time from labor induction to delivery without raising the risk of cesarean section in primiparous women with an unfavourable cervix.
Labor is a complex process that ultimately results in the expulsion of the foetus and placenta through the birth canal. Preparation for labor begins several weeks before the actual onset of labor. The onset of labor is controlled by endocrine and paracrine signals from both the mother and foetus. Broadly the processes that are involved in the physiology of labor are functional loss of factors that maintain pregnancy, synthesis of factors that induce labor and signals for the onset of labor. [1]
As a pregnancy progresses into its final weeks, several physiological changes occur in response to hormones that trigger labor. During the first several months of pregnancy, progesterone slows uterine contractions. Progesterone levels level down as the seventh month of pregnancy approaches. In maternal circulation, hoswever, oestrogen levels are still rising. Progesterone no longer inhibits contractions, thus when the ratio of oestrogen to progesterone increases, the uterine smooth muscle, or myometrium, becomes more responsive to stimuli which promote them. Additionally, during the eighth month of pregnancy, there is an increase in foetal cortisol, which causes the placenta to secrete more oestrogen and counteracts the uterine-calming effects of progesterone. False labor is another term for the weak and irregular peristaltic Braxton Hicks contractions that some women experience as a result of their progesterone levels dropping in the last stages of pregnancy. Resting or drinking plenty of water can frequently ease these contractions. Oxytocin is a hormone that causes labour contractions and has been secreted in greater amounts by the posterior pituitary. The myometrium expresses more oxytocin receptors at the same time, making it more sensitive to this hormone. As labor approaches, oxytocin causes greater, more painful uterine contractions, which, in a positive feedback loop, encourage the secretion of prostaglandins from foetal membranes.
Prostaglandins, like oxytocin, strengthen uterine contractions. Additionally, the foetal pituitary secretes oxytocin, which raises prostaglandin levels even more. Given the significance of prostaglandins and oxytocin for the start and maintenance of labor, it is not unusual that a pharmaceutical form of these substances is given when a pregnancy does not progress to labor and needs to be induced. Lastly, a full-term fetus in the vertex (head-down) position is expected to stretch the myometrium and cervix, which is thought to stimulate uterine contractions. The culmination of these modifications sets off the regular contractions known as "true labour" which gradually increase in strength and frequency.[2,3] Study done to compare between dinoprostone vaginal insert alone and mechanical method along with vaginal insert for cervical ripening in primigravida women.
A hospital-based prospective comparative observational study. All primigravida with in Niloufer hospital for women and children in Department of Obstetrics and Gynaecology, who give informed consent for the study. This study was conducted in 300 primigravida women between October 2022 and October 2024.
Inclusion criteria: Primigravida aged between 18-35yrs at ≥40 weeks gestational age in Singleton Cephalic Pregnancy
Exclusion criteria: Women with Bishops score > 6, with non vertex presentation, with maternal medical diseases and obstetric complications.
The sampling technique used for the present study was a convenient sampling technique. All the eligible patients satisfying the inclusion criteria were selected.
Based on a digital cervical exam, the Bishop scoring system assigns a minimum of zero points and a maximum of thirteen points to the patient. Cervical dilation, position, effacement, consistency of the cervix, and fetal station are all used in the grading system.
Cervical dilation is the measure of how dilated the cervix is in centimeters (cm). The average diameter of the open cervix is estimated in order to accomplish this. Effacement refers to the cervical thinning or shortening as a percentage (%) of its total length. A cervix with zero percent effacement is one that is normal in length before to childbirth. When the cervix is 50% effaced, it has reached half of its normal length and when the cervix is paper thin if it is fully effaced (100%). The fetal head's position in relation to the mother's pelvic ischial spines is known as the station. The pelvic entrance and outlet are separated by the ischial spines. The fetal head is level with the ischial spines at zero station. This level is divided into thirds above and below, with the zero station being represented by a positive number below and a negative number above. From -3, -2, -1, 0, +1, +2, +3 is the station that varies as a fetal head descends. The American College of Obstetrics and Gynecology redesigned station in 1989, going from -5 to +5, and measuring from the ischial spines in centimeters. The term position describes how the cervix is positioned in relation to the mother's pelvis and the fetal head. The consistency of the cervix refers to how the cervix feels during the examination. The consistency of a soft cervix is more like the lips of the oral cavity, whereas a hard cervix is more like the tip of the nose.
A Bishop score of 8 or higher is regarded favorable for induction, indicating that the chances of a vaginal delivery with induction are comparable to spontaneous labor. A score of 6 or lower is regarded unfavorable if an induction is required, cervical ripening drugs may be used. The most common modification to the Bishop score is a simplified scoring system that just takes into account dilation, effacement, and station (each scored 0 to 3 points). In this shortened modification, a score of more than 5 is considered favorable. APGAR scoring consists of five parts. Each category is weighted evenly with a value of 0, 1, or 2. The components are then summed up to obtain a total score which is recorded at 1 and 5 minutes after birth.
Prior to data collection, permission was sought from the institutional ethical committee. All consecutive patients admitted as inpatients in antenatal who are primigravida were included in this study. After taking informed consent from the participant attenders, socio-demographic and clinical data were collected, and bishop score is assessed.
Sociodemographic data assessed based on Kuppuswamy scale.[4] The ethical approval was obtained from the Institutional Ethics Committee (IEC) of Osmania Medical College, Hyderabad. Written informed consent was obtained from each participant who participated in the research study before enrolling. The researchers explained the details of the study and detailed the purpose of the study to the participants. Confidentiality was maintained throughout the period of data collection. Confidentiality was maintained by limiting the identifying variables to a minimum. Data were analysed in aggregate and access to the collected data was limited only to me, my guide and my co-guide. All information related to the study participants was kept confidential and de-identified data was used for analysis.
Data were entered into Microsoft excel and analysis was done using SPSS version 24. Categorical variables such as age group, Education, Religion, Occupation, Socio economic status, gestational age, Neonatal mortality, NICU / SNCU admission status, mode of delivery, indication of LSCS, birth weight and APGAR scores were summarized as frequencies and percentages
This section contains the description and analysis of the data collected, which are tabulated and described as follows.
Table-1: Demographic details in present study
Age in Years |
Group A (150) |
Group B (150) |
Total (N =300) |
<20 years |
22 (14.6%) |
32 (21.3%) |
54 (18%) |
20-25 years |
57 (38%) |
58 (38.6%) |
115 (38.8%) |
26-30 years |
51 (34%) |
43 (28.6%) |
94 (31.3%) |
31-35 years |
11 (7.3%) |
15 (10%) |
26 (8.6%) |
>35 years |
9 (6%) |
2 (1.3%) |
11 (3.6%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.107 |
||
Height in cms |
|
||
<140 Cm’s |
16 (10.6%) |
15 (10%) |
31 (10.33%) |
140-145 Cm’s |
27 (18%) |
38 (25.33%) |
65 (21.6%) |
145-150 Cm’s |
32 (21.3%) |
39 (26%) |
71 (23.6%) |
150-155 Cm’s |
57 (38%) |
47 (31.3%) |
104 (34.6%) |
>155 Cm’s |
18 (12%) |
11 (7.33%) |
29 (9.6%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.264 |
||
<45 Kgs |
18 (12%) |
16 (10.66%) |
34 (11.33%) |
45-50 Kgs |
19 (12.6%) |
21 (14%) |
40 (13.33%) |
51-55 Kgs |
29 (19.33%) |
30 (20%) |
59 (19.6%) |
56-60 Kgs |
35 (23.33%) |
34 (22.6%) |
69 (23%) |
61-65 Kgs |
31 (20.6%) |
26 (17.33%) |
57 (19%) |
>65 Kgs |
18 (12%) |
23 (15.33%) |
41 (13.6%) |
P VALUE |
0.935 |
|
|
Illiterate |
30 (20%) |
29 (19.33%) |
59 (19.6%) |
Primary |
48 (32%) |
49 (32.6%) |
97 (32.33%) |
Secondary |
31 (20.6%) |
37 (24.6%) |
68 (22.6%) |
Intermediate |
37 (24.6%) |
29 (19.33%) |
66 (22%) |
Degree |
4 (2.6%) |
6 (4%) |
10 (3.33%) |
P Value |
0.749 |
||
Occupation |
|
|
|
Unemployee |
61 (40.6%) |
89 (59.33%) |
125 (41.6%) |
Employee |
64 (42.6%) |
86 (57.33%) |
175 (58.3%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.725 |
|
|
Religion |
|
|
|
Hindu |
59 (39.33%) |
46 (30.6%) |
105 (35%) |
Muslim |
57 (38%) |
61 (40.6%) |
118 (39.33%) |
Christian |
26 (17.33%) |
36 (24%) |
62 (20.6%) |
Others |
8 (5.33%) |
7 (4.6%) |
15 (5%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.331 |
|
|
No statistical significance was noted between two groups.
Table -2: Distribution based on bishop score
Bishop Scores |
Group A (150) |
Group B (150) |
Total (N =300) |
1 |
19 (12.6%) |
36 (24%) |
55 (18.33%) |
2 |
45 (30%) |
51 (34%) |
96 (32%) |
3 |
86 (57.33%) |
63 (42%) |
149 (49.6%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.010 |
Most of the pregnant women bishop scores were 3 in both groups – 86/150 (57.33%) in Group A and 63/150 (42%) in Group B, followed by bishop score of 2 in both groups- 45/150 (30%) in Group A and 51/150 (34%) in Group B. With significance (P Value = 0.010) between two groups.
Table-3:Augmentation Methods
Augmentation Methods |
Group A (150) |
Group B (150) |
Total (N =300) |
Artifical Rupture Of Membranes (Arm) |
28 (18.6%) |
87 (58%) |
115 (38.33%) |
Oxytocin |
53 (37.33%) |
48 (32%) |
101 (33.6%) |
None |
58 (38.6%) |
15 (10%) |
73 (24.33%) |
ARM + Oxytocin |
11(7.33%) |
0 |
11 (3.6%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.000 |
Most of the Group A individuals 58/150 (38.6%) did not required any augmentation method, were as 87/150 (58%) i.e more then half of the Group B individuals required artificial rupture of memberans as an augmentation method. High significance (P value = 0.000) is noted between two groups.
Table -4 : Distribution based on amniotic fluid, Mode of delivery and Induction to delivery time.
Amniotic Fluid |
Group A (150) |
Group B (150) |
Total (N =300) |
Clear |
85 (56.6%) |
42 (28%) |
127 (42.33%) |
Meconium Stained Liquor (MSL 1) |
24 (16%) |
58 (38.6%) |
82 (27.33%) |
Meconium Stained Liquor (MSL 2) |
23 (15.33%) |
16 (10.6%) |
39 (13%) |
Meconium Stained Liquor (MSL 3) |
18 (12%) |
34 (22.6%) |
52 (17.33%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.000 |
||
Mode of delivery |
|
||
Normal Vaginal Delivery |
99 (66%) |
59 (39.33%) |
158 (52.6%) |
Lower Segment Cesarean Section |
51 (34%) |
91 (60.6%) |
142 (47.33%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.000 |
||
Induction to delivery time |
|
||
18 – 23 |
102 |
2 |
104 |
24 – 27 |
41 |
68 |
109 |
28 – 31 |
7 |
47 |
54 |
>32 |
0 |
33 |
33 |
Total |
150 (100%) |
Most of the Group A 85/150 (56.6%) have clear amniotic fluid, were as in Group B 58/150 (38.6%) have MSL -1 followed by 34/150 (22.6%) MSL-3. High significance (P value = 0.000) is noted between two groups. Most of the Group A pregnant women 99/150 (66%) underwent normal vaginal delivery, were as 91/150 (60.6%) Group B individuals underwent caesarean section. High significance (P value = 0.000) is noted between two groups. Most of the Group A (48/150) pregnant women have there induction to delivery time of 22hours, were as Group B (56/150) pregnant womens have there I -D interval of 24 hours. Significance is noted among both groups.
Table-5: Distribution based on weight of the new born baby
Weight of the baby (kg’s) |
Group A (150) |
Group B (150) |
Total (N=300) |
2.4 |
1 |
0 |
1 |
2.6 |
7 |
0 |
7 |
2.7 |
1 |
0 |
1 |
2.8 |
18 |
34 |
52 |
2.9 |
5 |
0 |
5 |
3 |
66 |
73 |
139 |
3.1 |
12 |
1 |
13 |
3.2 |
17 |
30 |
47 |
3.3 |
3 |
0 |
3 |
3.4 |
8 |
3 |
11 |
3.5 |
1 |
0 |
1 |
3.6 |
1 |
1 |
2 |
3.8 |
5 |
3 |
8 |
4 |
4 |
2 |
6 |
4.2 |
1 |
3 |
4 |
TOTAL |
150 (100%) |
150 (100%) |
300 (100%) |
P value |
0.000 |
Majority of the baby’s weight is around 3Kgs in both groups, followed by 2.8kgs, 3.2 Kgs of Group A pregnant womens. Higher significance (Pvalue =0.000) is noted among two groups.
Table-6: Distribution based on APGAR score
APGAR Score |
Group A (150) |
Group B (150) |
Total (N =300) |
5 |
1 (0.6%) |
4 (2.6%) |
5 (1.6%) |
6 |
3 (2%) |
10 (6.6%) |
13 (4.33%) |
7 |
9 (6%) |
18 (12%) |
27 (9%) |
8 |
68 (45.33%) |
77 (51.33%) |
145 (48.33%) |
9 |
69 (46%) |
41 (27.33%) |
110 (36.6%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.003 |
Majority of the new borns of Group A pregnant womens have Apgar scores of 8 among 69/150 (46%) and score of 9 among 68/150(45.33%) respectively, were as new borns of Group B pregnant womens have apgar score of 8. With significance of p value = 0.003 between both the groups.
Table-7: Neonatal intensive care unit (NICU/SNCU) admissions
NICU / SNCU Admissions |
Group A (150) |
Group B (150) |
Total (N =300) |
Admitted |
30 (20%) |
51 (34%) |
81 (27%) |
Not Admitted |
120 (80%) |
99 (66%) |
219 (73%) |
Total |
150 (100%) |
150 (100%) |
300 (100%) |
P Value |
0.006 |
Majority of new born of Group A 120/150 (80%) and group B 99/150 (66%) pregnant women did not admit in neonatal intensive care unit. Significance of P value= 0.006 is noted among both the groups.
Table-8: Correlation between sociodemographic and test variables with mode of delivery.
Group A (150) |
Group B (150) |
Total (300) |
||||
Pearson correlation |
Signific ance |
Pearson correlation |
Signific ance |
Pearson correlation |
Signifi cance |
|
Age |
0.062 |
0.454 |
0.035 |
0.668 |
0.019 |
0.744 |
Height |
0.053 |
0.523 |
-0.32 |
0.700 |
-0.015 |
0.799 |
Weight |
0.068 |
0.410 |
0.063 |
0.446 |
0.066 |
0.253 |
Education |
-0.081 |
0.323 |
0.000 |
0.995 |
-0.041 |
0.480 |
Occupation |
0.079 |
0.340 |
-0.005 |
0.954 |
0.029 |
0.613 |
Religion |
-0.028 |
0.729 |
-0.58 |
0.483 |
-0.068 |
0.238 |
SES |
-0.093 |
0.256 |
-0.045 |
0.584 |
-0.077 |
0.181 |
Bishop Score |
0.064 |
0.436 |
0.235** |
0.004 |
0.101 |
0.082 |
Augmentation Method |
0.054 |
0.511 |
-0.149 |
0.069 |
-0.156** |
0.007 |
Amniotic Fluid |
0.857** |
0.000 |
0.192* |
0.018 |
0.541** |
0.000 |
I–D Interval |
0.609** |
0.000 |
0.252** |
0.002 |
0.475** |
0.000 |
Weight Of The Baby |
0.447** |
0.000 |
0.446** |
0.000 |
0.423** |
0.000 |
Apgar Score |
-0.388** |
0.000 |
0.108 |
0.190 |
-0.160** |
0.006 |
NICU/SNCU Admissions |
-0.661** |
0.000 |
-0.491** |
0.000 |
-0.581** |
0.000 |
* - Significance level <0.05 (2-Tailed) ** - Significance level <0.01 (2-Tailed) |
Significant positive correlation is observed with the amniotic fluid, Induction to delivery time and weight of the baby, were as negative correlation is observed with APGAR score and NICU / SNCU admissions among the Group A pregnant women mode of delivery.
Among the Group B pregnant women significant positive correlation is observed with the bishop scores, amniotic fluid, Induction to delivery time and weight of the baby, where as negative correlation is observed with NICU / SNCU admissions.
Among the total study population positive correlation is observed with amniotic fluid, induction to delivery time and weight of the baby, where as negative correlation is observed with augmentation methods, APGAR scores and NICU / SNCU admissions. No significant correlation with the sociodemographic variables.
This current study investigated the mode of delivery, time duration from induction to delivery, newborn outcomes such as weight of the baby, APGAR score and NICU / SNCU admissions in hospitalized primigravida women. This study was done on 300 inpatients among these primigravida women’s, mechanical dilator along with dinoprostone vaginal insert and dinoprostone vaginal insert alone were administered and were divided into equal groups (Group A-150 and Group B- 150). Statistical analysis was done, and the results were compared.
Out of 300 primigravida 150 participants belong to Group A (mechanical dilator + dinoprostone vaginal insert) and 150 belong to Group B (dinoprostone vaginal insert alone). Among them the predominant age group of participants were between 20-25 years [115(38.8%)], with height ranging from 150-155 Cm’s [104(34.6%)] and weight varying from 55 – 60 Kg’s [69(23%)] followed by 61 – 65 Kg’s [57(19%)] in both the groups. Based on the religion the Hindus were predominant in Group A [59(39.33%)], were as Muslims among the Group B individuals [57(38%)].
Regarding the educational status majority were those who completed primary education in both groups [97(33.33%)] and as a total. Considering the occupational status majority were employees [175(58.3%)] and among them maximum participants were daily wage workers. Categorized under Modified Kuppuswamy Classification, majority of the participants belong to upper lower class among both the groups [122(40%)].
Assessment to determine the successful induction of labor, pelvic scoring system – BISHOP scoring resulted with majority of the participants had score of 3[149(49.6%)] in both groups followed by scores of 2[96(32%)] and 1[55(18.33%)].
Augmentation methods such as artificial rupture of membranes (ARM), Oxytocin were also used in this study as per the requirement. Majority of Group A individuals required none [58(38.6%)] of the augmentation methods, were as ARM has been done at higher rates among Group B individuals [87(58%)].
Based on the amniotic fluid assessment majority had clear fluid in Group A participants [85(56.6%)], on the other hand Group B participants had meconium-stained liquor 1 (MSL-1 [58(38.6%)] followed byMSL-3[34(22.6%)].
Normal vaginal deliveries rates are higher among this study [158(52.6%)]. On comparing both the groups, individuals who used mechanical dilator and dinoprostone vaginal insert (Group-A) had higher rates [99(66%)] of vaginal deliveries in contrast with dinoprostone vaginal insert alone used (Group B) individuals [59(39.33%)]. Caesarean section rates were higher among the individuals who used dinoprostone vaginal insert alone (Group B) [91(60.6%)].
Survival analysis also resulted superiority of combination therapy for the time from induction to delivery with majority being 22hours (48/150) for Group A were as 24 hours (56/150) for Group B individuals. Comparison of groups in terms of time from induction to active phase of labor and to delivery had high significance (p value 0.00).
Neonatal outcomes such as APGAR scores ranged from 5 to 9 in this study majority being the score of 8[145(48.33%)] and only 81(27%) new born admitted under neonatal intensive care unit.
Similar to this current study, a latest study which was done by Eser A et al.[5], to know the effectiveness of combined usage of intravaginal PGE2 insert and intracervical foley ballon catheter versus vaginal PGE2 insert alone. The study resulted with shorter duration from induction to delivery among the combined group (intracervical Foley balloon catheter and intravaginal PgE2 insertion). Both groups were found to be similar in terms of duration from induction to active stage of labor.
Edwards RK et al[6], assessed cervical ripening and labor induction at term by using combined dinoprostone vaginal insert and Foley catheter (DVI +Foley) with Foley alone (Foley) alone. Oxytocin was used in both groups after cervical ripening. This study resulted, combined use of the dinoprostone vaginal insert and Foley for cervical ripening may shorten time to vaginal delivery among nulliparous women, which is similar with the current study. Vallikkannu N et al.[7], evaluated induction to delivery interval and maternal benefits by using Foley catheter and controlled release dinoprostone insert compared to foley catheter alone. Shorter induction to delivery time, lesser usage of oxytocin and cesarean delivery rates are noted among the combined usage individuals; which are similar to the current study.
Vollegregt et al.[8] study showed intracervical PGE2 gel versus intravaginal insert. Majority of the individuals with insert achieved cervical ripening within 24hrs. Application membrane rupture interval and application delivery interval was shorter in insert group when compaired with gel group. Kalkat RK et al.[9] studied dinoprostone slow release pessary - propess and gel- prostin for induction of labor at term. Propess group reqired lower number of vaginal examination.
Larrañaga‐ - azcárate ca et al[10] studied dinoprostone vaginal slow-release system compared to expectant management in the active treatment of premature rupture of the membranes at term. The time of dilation to labor was significantly shorter and the rate of caesarean sections were also lesser in the dinoprostone group.[10]
Tirlapur SA et al[11], conducted a study between dinoprostone slow release pessary (propess) and gel (prostin) for induction of labor at term in nulliparous women. More then half of the propess group individuals achieved, vaginal delivery without any additional requirements. In contrast with above studies prostin group took only 13-24 hours, wereas propess group took over 85 hours for I – D time.
Bhide A et al[12]. Studied regarding feasibility of Prostaglandin insert dinoprostone versus trans-cervical balloon catheter for outpatient labour induction. Better neonatal outcomes were observed in the mechanical dilation along with dinoprostone vaginal insert group.
Several studies compared mechanical methods with medical methods. Very fewer studies are done about combined use of mechanical and medical methods together especially dinoprostone as the medical method. Thus, the current study focused on the combined use of mechanical and medical methods. Which resulted in good maternal and neonatal outcomes, such as lesser induction to delivery interval and augmentation methods, more number of vaginal deliveries, no maternal and neonatal complications or deaths with lesser NICU/SNCU admissions.
Our study has certain strengths that are worth mentioning. The randomized nature of the trial, Complete follow-up, 100% compliance, use of methods that account for competing events and diversity of our study population in terms of race/ethnicity. This study provides a review of the current research evidence on labor induction methods. A key strength of our study lies in the comprehensive and representative sample of pregnant women included in our research. We employed dedicated software for both data collection and analysis, significantly reducing the likelihood of errors and enhancing the accuracy and reliability of our study findings. The involvement of a single investigator in conducting all aspects of data collection represents another methodological strength of our study. Our study achieved an impressive response rate of 100% during the initial phase of data collection, minimizing the risk of non-response bias and strengthening the validity of our findings.
LIMITATIONS OF THE STUDY
We did not employ a placebo dinoprostone vaginal insert, so unmeasured bias could have been introduced by lack of blinding. The study was performed at a single center, potentially limiting the generalizability of our results. The study was a hospital-based study there was a chance of selection bias. The small sample size and the lack of blinding for the interventions may be accepted as drawbacks in this study. Lack of neonatal follow up after 7 days. The availability of better NICU / SNCU facilities in our hospital probably would have minimized the neonatal morbidity. We have assessed foetal distress using FHR tracings. Foetal acidosis would have been a better measure to identify the accurate foetal distress. Multi gravida women; women with Bishop score more than 6; women with non-vertex presentation and women with maternal medical diseases and obstetric complications were not included in study limiting the generalizability of our results.
In conclusion, this study provided a comprehensive insight into the demographic characteristics, and study variables such as Age, Education, Religion, Occupation, Socio economic status, Weight of the baby, APGAR score at 5 minutes, Neonatal mortality, NICU / SNCU admission status, Birth weight among primigravida women.
The findings underscored the predominance of individuals in their mid- twenties requiring induction, with a significant proportion completing their primary education and belonging to the Hindu religion. Moreover, the majority of pregnancies were spontaneous and, with all deliveries occurring at term gestation and within the normal birth weight range. We think that the results of the current study are intriguing and suggest that the finding of a shorter time to vaginal delivery in primigravida women with the combined use of Foley and the dinoprostone vaginal insert compared to dinoprostone vaginal insert alone should be evaluated in a large multicentre trial.
Our data showed 5.4 h reduction in mean time from induction to delivery. The study shed light on the reduced LSCS rate in women with the combined use of mechanical dilation and the dinoprostone vaginal insert. Indications for LSCS primarily included fetal distress and contracted pelvis, highlighting the challenges encountered during childbirth. Neonatal outcomes revealed a considerable proportion requiring NICU / SNCU admission, predominantly in women with use of the dinoprostone vaginal inert alone may be due to respiratory distress syndrome, emphasizing the effects of prolonged induction delivery interval on neonates.
In conclusion, combined application of mechanical and dinoprostone vaginal insert and dinoprostone insert may result in a shorter time from labor induction to delivery without raising the risk of cesarean section in primiparous women with an unfavourable cervix.