Background & Methods: The aim of the study is to compare study of Induction of Labor with Cerviprime Vs Misoprostol. The study was conducted in the Department of Obstetrics and Gynaecology, Amaltas Institute of Medical Sciences, Dewas (M.P.), which serves as a tertiary care referral center. Results: Out of 108 participants, 23 underwent induction due to gestational diabetes mellitus (GDM), comprising 21.3% of the total. Oligohydramnios accounted for 21 cases or 19.4%. Pregnancy-induced hypertension (PIH) was the indication in another 23 participants, again representing 21.3%. A postdated pregnancy led to induction in 26 cases or 24.1%, while premature rupture of membranes (PROM) was reported in 15 participants and accounts for 13.9%. The cumulative percentages for these categories were 21.3%, 40.7%, 62.0%, 86.1% and 100.0%, respectively. Postdated pregnancy was the most frequent reason for induction, closely followed by GDM and PIH. Together, these three indications accounted for nearly two-thirds of all inductions. Conclusion: Clinical implications arise from these findings. Cerviprime emerged as a preferred agent for induction where rapid, predictable response and fewer complications are desirable. It provided better outcomes without increasing intervention rates or exposing patients to excessive risk. Misoprostol remained effective but showed increased uterine activity and fetal compromise; selection requires careful consideration of individual patient profiles.
Achieving cervical effaction, dilatation, and finally delivery of the fetus depends on induction of labor—the medical process by which uterine contractions are started artificially before the natural beginning of labor[1]. In 5–25% of pregnancies, this intervention becomes essential especially when mother or fetal well-being is at risk should the pregnancy last [2]. Labor inductions have become rather common in recent years, particularly in developed nations where about 25% of term deliveries follow from induction [3].
Low-dose misoprostol is one of the prostaglandin analogues advised by clinical guidelines from the American College of Obstetricians and Gynecologists (ACOG) and the World Health Organization (WHO) as efficient agents for cervical ripening and labor induction.[4]
PGE1 (Misoprostol) and PGE2 (Dinoprostone, sold as Cerviprime gel) are the two prostaglandin analogues most used in present obstetric practice. Usually not exceeding four doses, misoprostol is given vagally every three hours in 25 microgram doses. On the other hand, a 50 microgram oral dosage taken every four hours has also shown success [6].Conversely, Cerviprime is given as a 0.5 mg intracervical gel and may be repeated after six hours up to a maximum of three or four doses. Usually advised to rest after application, patients are under cardiotocography monitoring for fetal well-being.
Although labor induction has benefits, adoption of it in low-resource environments is still restricted due to worries about complications including failed inductions leading to lower segment cesarean sections (LSCS), uterine hyperstimulation, and financial restrictions related with prostaglandin preparations [7]. Misoprostol reportedly causes uterine tachysystole, hypertonus, passage of meconium, and, in rare cases, uterine rupture.
Initiating strong uterine contraction with cervical changes, attaining vaginal delivery, and reducing risks and discomfort to both mother and fetus in viable pregnancies define three main objectives of a successful labor induction [8].
The U.S. Food and Drug Administration (FDA) changed its misoprostol label in April 2002 to clarify its contraindication for ulcer prevention in pregnancy but not for obstetric use where benefits exceed the risks.
A simple random sampling technique was employed. Eligible participants were randomly allocated into two groups of 54 patients each:
The study population included pregnant women admitted for induction of labor with varied obstetric indications as per the inclusion criteria.
Inclusion Criteria
Exclusion Criteria
Table 1: Descriptive Statistics of Maternal Age in the Cerviprime and Misoprostol Groups
Group |
Count |
Mean |
SD |
min |
max |
Cerviprime |
54.00 |
28.57 |
5.47 |
19.00 |
38.00 |
Misoprostol |
54.00 |
27.67 |
6.16 |
19.00 |
38.00 |
The Cerviprime group consisted of 54 participants with a mean age of 28.57 years and a standard deviation of 5.47. The minimum and maximum recorded ages in this group were 19.00 and 38.00 years, respectively. Similarly, the Misoprostol group included 54 participants with a mean age of 27.67 years and a standard deviation of 6.16; the minimum and maximum ages in this group were also 19.00 and 38.00 years.
Table 2: Descriptive Statistics of Bishop Scores in Cerviprime and Misoprostol Group
Group |
Count |
Mean |
SD |
Min |
Median |
Max |
Cerviprime
|
54 |
6.11 |
1.81 |
3 |
6 |
9 |
Misoprostol |
54 |
6.13 |
2.17 |
3 |
6 |
9 |
In the Cerviprime group, the mean Bishop score was 6.11 with a standard deviation of 1.81. Scores ranged from 3.00 to 9.00. In the Misoprostol group, the mean score was 6.13 with a standard deviation of 2.17 and the range was similarly from 3.00 to 9.00. Median values for both groups were 6.00. The Bishop score distribution was nearly identical between groups. This indicated comparable cervical favourability before induction.
Table 3: Frequency and Percentage Distribution of Obstetric History
Obstetric History |
Frequency (n) |
Percentage (%) |
Cumulative Percentage (%) |
G1P0L0 |
38 |
35.2 |
35.2 |
G2P1L1 |
42 |
38.9 |
74.1 |
G3P2L2 |
28 |
25.9 |
100 |
Total |
108 |
100 |
— |
The first category comprised 35.2% of the participants. This increased cumulatively to 74.1% in the second category and reached 100.0% in the final category. The cumulative distribution suggests that just over a third of the participants fell into the initial obstetric category, with the majority represented across the subsequent two.
Table 4: Frequency and Percentage Distribution of Gestational Age at Induction
Gestational Age |
Frequency (n) |
Percentage (%) |
Cumulative Percentage (%) |
<37 weeks |
52 |
48.1 |
48.1 |
37–42 weeks |
56 |
51.9 |
100 |
Total |
108 |
100 |
— |
Out of 108 participants, 52 were induced before 37 weeks of gestation, constituting 48.1% of the sample. The remaining 56 participants or 51.9%, underwent induction between 37 and 42 weeks of gestation. Cumulative percentages reached 48.1% for the <37 weeks group and 100.0% upon inclusion of the term group. The distribution was nearly even, with a slight majority of inductions occurring at term.
Table 5: Frequency and Percentage Distribution of Indications for Labour Induction
Indication |
Frequency (n) |
Percentage (%) |
Cumulative Percentage (%) |
GDM |
23 |
21.3 |
21.3 |
Oligohydramnios |
21 |
19.4 |
40.7 |
PIH |
23 |
21.3 |
62 |
Postdated Pregnancy |
26 |
24.1 |
86.1 |
PROM |
15 |
13.9 |
100 |
Total |
108 |
100 |
— |
Out of 108 participants, 23 underwent induction due to gestational diabetes mellitus (GDM), comprising 21.3% of the total. Oligohydramnios accounted for 21 cases or 19.4%. Pregnancy-induced hypertension (PIH) was the indication in another 23 participants, again representing 21.3%. A postdated pregnancy led to induction in 26 cases or 24.1%, while premature rupture of membranes (PROM) was reported in 15 participants and accounts for 13.9%.
The cumulative percentages for these categories were 21.3%, 40.7%, 62.0%, 86.1% and 100.0%, respectively.
Postdated pregnancy was the most frequent reason for induction, closely followed by GDM and PIH. Together, these three indications accounted for nearly two-thirds of all inductions.
Evaluating the effects of each induction agent on the mother and the developing baby was one of the secondary goals[9]. The research looked at safety profiles by looking at how often side events such uterine rupture, hypertonus, tachysystole, and meconium passage occurred. The results of the neonatal period were documented using the following criteria: live births, stillbirths, and intrauterine fetal death. Understanding the potential impact of maternal traits, obstetric factors, and baseline cervical abnormalities on induction outcomes, as well as averting primary caesarean sections, received extra focus. For obstetric care decision-making based on data, the objective framework allowed for a multi-dimensional assessment of safety and effectiveness[10].
Cerviprime and Misoprostol Groups According to Maternal Age: The sample sizes of the two groups were 54. Average age was 28.57 (SD 5.47) in the cerviprime group and somewhat lower at 27.67 (SD 6.16) in the misoprostol group. In both groups, the ages of the participants varied from nineteen to thirty-eight. There was no correlation between differences in induction results and variations in maternal age since the two cohorts had the same age range[11]. There was no distortion or impact on the outcomes from the trial caused by the Cerviprime group having a slightly higher mean.
Parmar et al. (2014) found that the Cerviprime group had a mean mother age of 23.68 years and a standard deviation of 3.11, whereas the Misoprostol group had a mean maternal age of 23.32 years and a standard deviation of 2.91. Participants' ages ranged from twenty-five to thirty-plus. When comparing the groups, no statistically significant difference was observed (p > 0.05). We were able to compare outcomes free from the confounding impact of maternal age since the two cohorts were demographically matched, reducing age-related bias[12].
Labour induction was initiated based on five primary clinical indications. Postdated pregnancy was the most frequent reason, observed in 26 participants (24.1%). Induction was also performed in 23 cases (21.3%) each for gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH). Oligohydramnios was reported in 21 participants (19.4%), while premature rupture of membranes (PROM) was documented in 15 participants (13.9%). Together, postdated pregnancy, GDM and PIH accounted for 66.7% of all cases[13].
Mukhopadhyay et al. (2020)[14] reported that postdatism was the most frequent indication for induction in both groups—71.05% in the Cerviprime group and 51.22% in the Misoprostol group. Pregnancy-induced hypertension followed with 17.07% in the Misoprostol group and only 2.63% in the Cerviprime group. Oligohydramnios was the second most frequent cause in the Cerviprime group at 9.21%, while gestational diabetes mellitus was the third in both groups—7.89% in Cerviprime and 6.1% in Misoprostol. Other less frequent indications included intrahepatic cholestasis of pregnancy (ICP), fetal growth restriction and decreased fetal movements.
Our study aimed to compare efficacy and safety of two pharmacological agents—Cerviprime and Misoprostol—for induction of labour. Objectives were to evaluate which agent led to higher rates of vaginal delivery and to assess maternal and fetal outcomes following administration. goals were to examine onset, progress and completion of labour and to minimise surgical intervention through effective cervical ripening and induction.
Clinical implications arise from these findings. Cerviprime emerged as a preferred agent for induction where rapid, predictable response and fewer complications are desirable. It provided better outcomes without increasing intervention rates or exposing patients to excessive risk. Misoprostol remained effective but showed increased uterine activity and fetal compromise; selection requires careful consideration of individual patient profiles.