Open access peer-reviewed chapter
Distribution by age group in the two groups.
Abstract
Cervical maturation in the third trimester is crucial to prepare the cervix for childbirth and ensure successful vaginal delivery. This study aimed to describe the profile of patients requiring cervical maturation and evaluate the outcomes of mechanical and chemical methods. A retrospective study was conducted on 100 parturients at the Obstetric Gynecology Department "D" of Tunis maternity and neonatology center (CMNT) between 2020 and 2022. Pregnant women at term with unfavorable Bishop scores and cephalic presentation were included. Exclusions were based on contraindications to vaginal delivery and multiple pregnancies. The primary outcome was the rate of vaginal delivery, with secondary outcomes including labor duration and maternal and neonatal results. The average patient age was 29 years, with 50% being primiparous. Post-term pregnancy was the most common indication for cervical maturation. The Foley catheter was used in 70% of cases, while Misoprostol was used in 30%. Labor lasted 15 hours with Misoprostol and 18 hours with the Foley catheter. Vaginal delivery occurred in 80% of cases, with a 40% cesarean rate for failed inductions. Tachysystole occurred in 6% of cases, and perineal tears were reported in 26.09% (Misoprostol) and 21.06% (Foley catheter) cases. Most newborns had satisfactory Apgar scores, with 5% requiring resuscitation and 10% needing hospitalization. Both methods are effective, but risks require careful management.
Keywords
- childbirth
- Misoprostol
- extra-amniotic balloon
- cervical ripening
- obstetric labor
1. Introduction
Cervical maturation in the third trimester is a critical step in preparing the cervix for childbirth. It involves essential anatomical and physiological changes such as dilation, effacement, and softening, which are necessary for a smooth and efficient labor process. However, in some women, cervical immaturity can lead to obstetric complications, including prolonged labor, higher cesarean rates, and increased maternal and fetal health risks [1, 2].
In Tunisia, specific epidemiological factors, including limited access to proper care and deteriorating healthcare infrastructure, exacerbate these complications. Despite the importance of cervical maturation, few studies have focused on this issue within the Tunisian population, highlighting a significant gap in the literature [3]. Cervical ripening methods, including mechanical methods such as the Foley catheter and pharmacological agents like Misoprostol, are commonly used [4].
However, the use of Misoprostol for cervical ripening lacks official market authorization (AMM) in some countries, such as Tunisia and France [5, 6].
This study aims to address this gap by describing the epidemiological profile of pregnant women requiring cervical maturation in the third trimester and reporting on the outcomes of mechanical and chemical methods used to facilitate the process.
2. Materials and methods
2.1 Study design
This was a retrospective, descriptive, observational study conducted at a single center, focused on clinical case series.
2.2 Study period and location
The study took place at the Department D of Gynecology and Obstetrics at the Maternity and Neonatology Center of Tunis (CMNT), spanning from January 2020 to December 2022.
2.3 Study population
Inclusion criteria : Women with a single-term pregnancy (>37 weeks), age >18 years, advanced term (≥41 weeks), cephalic presentation, unfavorable Bishop score (<6), and a normal fetal heart rate (FHR) were included. Informed consent was obtained from all participants.Exclusion criteria : Women with contraindications to vaginal delivery or medical contraindications to the use of Misoprostol or the extra-amniotic catheter were excluded (e.g., severe asthma, known prostaglandin allergy, placenta previa).Exclusion of records : Patients with incomplete or missing medical records, those lost to follow-up, or those who left against medical advice were excluded.
2.4 Data collection
Data were extracted from patient medical records and delivery logs. A standardized form, developed based on literature, was completed anonymously using this information. Variables were compiled into a comprehensive dataset for analysis.
2.5 Data analyzed
General population description :Maternal age (<25, 25–35, ≥35 years)
BMI categories: underweight (<20), normal (20–25), overweight (25–30), moderate obesity (30–35), severe obesity (≥35)
Medical and surgical history (e.g., diabetes, hypertension, thyroid dysfunction)
Gynecological history (e.g., gravidity, parity, previous cesarean sections)
Pregnancy details: term at admission, prenatal follow-ups, and ultrasound findings
Fetal data: estimated fetal weight, amniotic fluid volume, and FHR
Labor induction characteristics :Gestational age at induction (categorized: 37–38 + 6 weeks, 39–40 + 6 weeks, ≥41 weeks)
Primary reasons for induction (e.g., post-term, gestational diabetes, reduced fetal movements)
Bishop score prior to induction (<3, 4–5, ≥6)
Methods of cervical ripening (Misoprostol, extra-amniotic catheter, or both)
Duration of labor phases (latent and active), dosage of Misoprostol, and time to labor onset
Labor and delivery outcomes :Total labor duration, amniotic fluid characteristics (clear, stained, meconium)
Use of oxytocin, FHR abnormalities (CNGOF classification: green, yellow, orange, red)
Delivery mode (spontaneous, instrumental, cesarean)
Episiotomy and indications for instrumental or cesarean delivery
Maternal outcomes :Uterine contractility issues, perineal tears, uterine rupture, postpartum hemorrhage
Neonatal outcomes :Birth weight, Apgar score at 1 and 5 minutes, need for resuscitation, neonatal unit admission
2.6 Cervical maturation
2.6.1 Maturation techniques
Foley catheter
Mechanical method used to dilate the cervix by applying controlled pressure through a Foley catheter (18 Fr gauge) filled with 60 ml of saline. The catheter stays in place until it naturally falls out, with a maximum duration of 24 hours.
Procedure: visual inspection of the cervix using a speculum, antiseptic cleaning with Betadine, catheter insertion, balloon inflation, and traction application.
Equipment: sterile gloves, speculum, saline, clamps, Foley catheter, etc.
Misoprostol
Synthetic prostaglandin E1 analog, used for its quick action and low cost.
Administration methods: oral, sublingual, vaginal (vaginal dosage: 50 μg every 8 hours, up to 3 doses within 24 hours).
Fetal heart rate monitoring (FHR) is conducted 1 hour before and after each dose.
2.6.2 Maturation protocols
After the decision to induce labor, an initial Bishop score is calculated, and FHR is monitored. Following Foley or Misoprostol administration, regular FHR checks are conducted.
If the Bishop score remains unfavorable post-treatment, oxytocin (Syntocinon®) may be used. Labor induction failure is defined by an inability to achieve a favorable Bishop score after six Misoprostol doses.
Labor monitoring continues via vaginal exams and contractions. Labor details are documented in the partogram.
2.7 Bibliographic research
Key databases used: NCBI, Science Direct, ClinicalKey, Cochrane, and medical university databases.
Keywords: labor induction, Misoprostol, Foley catheter, cervical maturation, obstetric labor
2.8 Statistical analysis
Studied variables
Epidemiological variables: Age, medical/surgical history, BMI, parity, number of natural deliveries
Pregnancy variables: Complications, gestational age, reasons for induction
Induction protocol: Latency and active labor phases, delivery method, and complications
Neonatal outcome: APGAR score, birth weight, reasons for NICU admission
Maternal outcome: Uterine hypertonia, rupture, hemorrhage, and perineal tears
Statistical analysis
Descriptive: Qualitative variables (frequencies) and quantitative variables (means, standard deviation, or medians)
Analytical: Chi-square tests for qualitative variables, T-test or Mann–Whitney U test for quantitative
2.9 Ethical agreement and data protection
Data was collected after receiving department approval, and all patient information was anonymized to protect privacy. Data integrity and confidentiality were maintained throughout the study.
2.10 Conflict of interest declaration
No conflicts of interest or external funding influenced the study results.
3. Results
3.1 Maternal and obstetric data
3.1.1 Age
The mean age was higher in the extra-amniotic group (30.2 years) compared to the Misoprostol group (28.5 years), with no significant difference (p = 0.84) (Table 1).
| Age group | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| 20–25 | 23.34 | 18.57 | 0.84 |
| 26–30 | 36.67 | 40 | 0.64 |
| 31–35 | 26.67 | 28.57 | 0.61 |
| 36–40 | 10 | 10 | 0.92 |
| 41–45 | 3 | 2.85 | 0.99 |
Table 1.
3.1.2 Weight and height
The mean weight was 72.15 kg in the Misoprostol group and 75.16 kg in the extra-amniotic group. No significant differences in weight (p = 0.45) or height (p = 0.35) were observed.
3.1.3 BMI
The mean BMI in the Misoprostol group was 26.53, while it was 28.66 in the extra-amniotic group, with no significant difference (p = 0.45) (Table 2).
| BMI | Misoprostol | Extra-amniotic | p-Value |
|---|---|---|---|
| Mean | 26.53 | 28.66 | 0.45 |
| Minimum | 17.89 | 23.15 | |
| Maximum | 34.10 | 40.10 |
Table 2.
BMI of patients in our series.
3.1.4 Medical history
A total of 21% of patients had chronic conditions such as diabetes, asthma, and hypothyroidism. There was no significant difference between groups (p = 0.44) (Table 3).
| Medical history | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| Yes | 20 | 21.42 | 0.44 |
| No | 80 | 78.57 | 0.44 |
Table 3.
Medical history of patients in our series.
3.1.5 Surgical history
Totally, 5% of patients had a history of surgery (e.g., appendicectomy, cholecystectomy). There was no significant difference (p = 0.88).
3.1.6 Gestational age
The average gestational age was similar across both groups (Misoprostol: 38 weeks + 5 days; extra-amniotic: 39 weeks + 1 day). No significant difference was found (p = 0.84) (Table 4).
| Gestational age | Misoprostol (n = 30) (%) | Extra-Amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| 37–37 + 6 weeks | 6.66 | 11.42 | 0.84 |
| 38–38 + 6 weeks | 33.34 | 21.42 | 0.64 |
| 39–39 + 6 weeks | 23.34 | 24.28 | 0.99 |
| 40–40 + 6 weeks | 10 | 17.14 | 0.61 |
| >41 weeks | 26.66 | 25.71 | 0.92 |
Table 4.
Distribution of patients by pregnancy term.
3.2 Induction and labor data
3.2.1 Indication for induction
The most common indications were post-term pregnancy and premature rupture of membranes (Misoprostol) or preeclampsia (extra-amniotic group) (Table 5).
| Indication | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| Post-term pregnancy | 26.66 | 25.72 | 0.80 |
| Preeclampsia | 16.66 | 24.28 | 0.38 |
| Gestational diabetes | 6.66 | 10 | 0.70 |
| Double dysgravidy (HTN + GD) | 10 | 17.14 | 0.70 |
| Premature rupture of membranes >12 h | 23.33 | 0 | 1.00 |
Table 5.
Distribution of patients by labor induction indications.
3.2.2 Bishop score
The mean initial Bishop score was 3.4, with no significant difference between groups (p = 0.65) (Table 6).
| Bishop score | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| ≤3 | 23.34 | 35.71 | 0.65 |
| 3–4 | 46.66 | 40 | 0.88 |
| 5 | 30 | 24.28 | 0.73 |
Table 6.
Distribution of patients by initial Bishop score.
3.2.3 Labor duration
The total labor duration was longer in the extra-amniotic group (18 h 30 m) compared to the Misoprostol group (15 h 20 m) though the difference was not significant (p = 0.15) (Table 7).
| Labor duration (hours) | Misoprostol (n = 23) (%) | Extra-amniotic (n = 57) (%) | p-Value |
|---|---|---|---|
| <12 h | 34.78 | 26.31 | 0.15 |
| 12–24 h | 43.48 | 61.40 | |
| >24 h | 21.74 | 13.72 |
Table 7.
Population distribution by labor induction.
3.2.4 Amniotic fluid
There was a higher occurrence of stained amniotic fluid in the Misoprostol group (17%) compared to the extra-amniotic group (10%), but this difference was not significant (p = 0.14) (Table 8).
| Amniotic fluid | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| Clear | 76.67 | 82.85 | 0.84 |
| Stained | 16.67 | 10 | 0.14 |
| Meconium | 6.66 | 7.15 | 0.99 |
Table 8.
Amniotic fluid color by induction method.
3.2.5 Oxytocin use
Oxytocin was administered to 67 patients, with no significant difference between groups (p = 0.75) (Table 9).
| Oxytocin use | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| Yes | 63.33 | 68.57 | 0.75 |
| No | 36.67 | 31.43 |
Table 9.
Use of oxytocics by induction method.
3.2.6 Fetal heart rate (FHR) abnormalities
FHR monitoring showed pathological traces in 40% of parturients. There was no significant difference between groups (p = 0.66) (Table 10).
| FHR abnormalities | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| Pathological Traces | 43.33% | 38.57% | 0.66 |
Table 10.
FHR abnormalities by induction method.
3.3 Mode of delivery and complications
3.3.1 Mode of delivery
The cesarean section rate was slightly higher in the Misoprostol group (23.34%) compared to the extra-amniotic group (18.58%), though the difference was not statistically significant (p = 0.21) (Table 11).
| Delivery mode | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| Vaginal | 66.66 | 78.57 | 0.70 |
| Instrumental | 10 | 2.85 | 0.03* |
| Cesarean | 23.34 | 18.58 | 0.21 |
Table 11.
Delivery rates by induction method.
Significant p-value for instrumental delivery between groups.
3.3.2 Indications for cesarean
The primary reasons for cesarean were failed induction and fetal distress, with no significant difference between groups (p = 0.88) (Table 12).
| Indication for cesarean | Misoprostol (n = 7) (%) | Extra-amniotic (n = 13) (%) | p-Value |
|---|---|---|---|
| Failed induction | 42.87 | 38.46 | 0.88 |
| Fetal distress | 28.57 | 30.78 | 0.65 |
Table 12.
Indications for cesarean delivery.
3.3.3 Complications during labor
Labor complications occurred in 15% of patients in the Misoprostol group and 17% in the extra-amniotic group, with no significant difference (p = 0.3) (Table 13).
| Complications | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| Yes | 23.33 | 25.71 | 0.30 |
| No | 76.67 | 73.29 |
Table 13.
Labor complications.
3.4 Neonatal outcomes
3.4.1 Birth weight
Neonatal birth weights averaged 3483 g in the Misoprostol group and 3560 g in the extra-amniotic group. No significant differences were observed (p = 0.91) (Table 14).
| Birth weight (g) | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| <2500 | 13.33 | 8.57 | 0.87 |
| 2500–4000 | 80 | 87.14 | 0.91 |
| 4000–4500 | 6.66 | 4.29 | 0.84 |
Table 14.
Birth weight in our population.
3.4.2 Apgar scores
Apgar scores at 1 and 5 minutes were similar between groups, with no significant differences (p = 0.95) (Table 15).
| Apgar score | 1 min – misoprostol (%) | 1 min - extra-amniotic (%) | 5 min – misoprostol (%) | 5 min - extra-amniotic (%) | p-Value |
|---|---|---|---|---|---|
| 7–10 | 87 | 92 | 100 | 100 | 0.95 |
Table 15.
Apgar score at 1 minute and 5 minutes in our population.
3.4.3 NICU admission
NICU admission rates were slightly higher in the Misoprostol group (13%) compared to the extra-amniotic group (10%), but the difference was not statistically significant (p = 0.96) (Table 16).
| NICU admission | Misoprostol (n = 30) (%) | Extra-amniotic (n = 70) (%) | p-Value |
|---|---|---|---|
| Yes | 13 | 10 | 0.96 |
| No | 87 | 90 |
Table 16.
Neonatal unit hospitalizations.
4. Discussion
4.1 Summary of results
Induction of labor involves artificially initiating labor before its spontaneous onset with the aim of facilitating childbirth. This procedure has become increasingly common worldwide, including in Tunisia, where it is one of the most frequently performed interventions in obstetric care. Despite the lack of market authorization for Misoprostol in Tunisia and the high authority of health (HAS) in France’s guidelines advising against the regular use of the extra-amniotic balloon catheter, both methods are widely used for cervical ripening in clinical practice.
Our study included 100 pregnant women in the third trimester, all of whom underwent cervical ripening with either the extra-amniotic balloon catheter or Misoprostol. The aim was to compare the effectiveness and safety of these methods in terms of labor progression, mode of delivery, and maternal and neonatal outcomes. The average age of the participants was 29 years, with a notable majority presenting with either normal weight or overweight, and 21% classified as obese. The most common indication for induction was post-term pregnancy (45%), followed by other factors like decreased fetal movements, prolonged rupture of membranes (RPM), gestational diabetes, and preeclampsia.
In 70% of cases, the extra-amniotic balloon catheter was used, while the remaining 30% of cases were induced using Misoprostol. Despite the differences in the techniques, both methods were equally effective in inducing labor, with the majority of women delivering vaginally. There were no significant differences in the total duration of labor between the two groups. Importantly, there was no evidence of increased maternal or neonatal morbidity associated with either method of induction.
4.2 Discussion of results
4.2.1 Epidemiological profile of the parturients
4.2.1.1 Age
Maternal age plays a crucial role in determining the mode of delivery, particularly in terms of cesarean rates. Studies have demonstrated that advanced maternal age, typically defined as 35 years and older, is associated with a significantly higher risk of cesarean section due to complications like prolonged labor or fetal distress [7]. Research by the American College of Obstetricians and Gynecologists [7] emphasizes that the likelihood of cesarean delivery increases markedly in women aged 40 and above, with the risks being threefold higher compared to younger women [8].
Our study, however, involved a younger population with an average age of 29 years. This aligns with previous studies where younger maternal age was linked to higher rates of successful vaginal deliveries [1, 9]. The relative youth of our cohort likely contributed to the high success rate of vaginal deliveries observed. However, larger studies that span a wider age range may reveal trends more in line with advanced maternal age and cesarean risk [10, 11].
4.2.1.2 Parity
Parity is another important predictor of labor induction success. Nulliparous women (those giving birth for the first time) are generally more prone to complications during labor induction, with increased rates of cesarean section compared to multiparous women (those who have given birth before) [12, 13].
Our findings are consistent with the literature; multiparous women in our study were more likely to deliver vaginally. This may be due to their more favorable cervical status and uterine muscle responsiveness, as previously noted in studies such as those by Leelarujijaroen et al. [14] and Diaz-Martinez et al. [15, 16, 17].
4.2.1.3 Body mass index (BMI)
The relationship between obesity and labor induction failure has been well established. In our study, women with a BMI of 30 or higher had a significantly higher rate of cesarean section compared to women with a BMI below 30, a finding that mirrors previous research [12, 18]. Several studies, including those by Ellis et al. [19], highlight that obesity complicates cervical ripening and prolongs labor, often necessitating higher doses of oxytocin and increasing the chances of cesarean delivery [20].
Further, studies have shown that obese women may have a slower cervical response to prostaglandins, including Misoprostol, due to alterations in hormonal sensitivity or distribution [10]. This suggests that BMI should be considered when choosing an induction method, as certain techniques might be less effective in obese patients [10, 12].
4.3 Evaluation of the effectiveness of ripening methods
4.3.1 Labor progression
Our study found no significant difference in labor progression between the extra-amniotic balloon catheter and Misoprostol groups, a finding consistent with the results of the PROBAAT-II trial [21, 22] and studies by Lanka et al. [23], which reported comparable labor durations for both methods [20, 24]. However, studies such as Levine et al. [25] demonstrated that combining Misoprostol with mechanical methods like the Foley catheter can significantly reduce the induction-to-delivery interval [13, 26].
These differences highlight the importance of tailoring cervical ripening methods to individual patient profiles, as certain combinations may yield faster and more efficient labor progress in specific populations, such as those with higher parity or more advanced maternal age (Table 17) [27].
| Study | Year | Country | Misoprostol | Foley catheter | Combined | p-Value |
|---|---|---|---|---|---|---|
| Lanka et al. | 2014 | Nigeria | 27.64 h (15.63) | 26.52 h (15.24) | ** | 0.65 |
| Levine et al. | 2016 | USA | 17.6 h | 17.7 h | 13.1 h | 0.001 |
| PROBAAT-II | 2016 | Netherlands | 29 h | 30 h | ** | 0.97 |
| Gilani et al. | 2018 | Pakistan | 19.26 h | ** | 16.46 h | 0.033 |
| Al-Ibraheemi et al. | 2018 | USA | 19 h | ** | 15 h | 0.001 |
| Osoti et al. | 2018 | Kenya | 18.9 h | ** | 14.1 h | <0.001 |
| Priyadarshini et al. | 2021 | India | 24.99 h | ** | 19.65 h | 0.002 |
| Inamdar et al. | 2020 | India | 17.9 h | ** | 14.6 h | <0.0001 |
| 2023 | Tunisia | 8h + 53 min | 15 h + 26 min | 15 h + 26 min | 0.02 |
Table 17.
Time between ripening and onset of uterine contractions.
Table 17 illustrates the variation in labor progression between studies. Our findings are comparable with international data, showing that the extra-amniotic balloon catheter led to shorter times to onset of uterine contractions than Misoprostol alone, a pattern also observed in other countries.
4.3.2 Vaginal delivery rates within the first 24 hours
The rate of vaginal delivery within the first 24 hours of induction is a key indicator of the success of labor induction techniques. In our study, 76.66% of women who received Misoprostol delivered vaginally, compared to 81.42% in the extra-amniotic balloon group. These rates align with other studies, such as Aduloju et al. [24], which found similar vaginal delivery rates between mechanical and pharmacological induction methods [17].
While some studies suggest a slight advantage for mechanical methods, others, including the work of Osoti et al. [20], have demonstrated that Misoprostol alone is just as effective when administered under appropriate conditions [28]. This variation highlights the need for clinical flexibility when selecting induction methods, especially in resource-limited settings (Table 18) [13, 20].
| Study | Year | Country | Misoprostol | Foley catheter | Combined | p-Value |
|---|---|---|---|---|---|---|
| Lanka et al. | 2014 | Nigeria | 50.79% | 50.79% | ** | 1.00 |
| Levine et al. | 2016 | USA | 70% | 73.2% | 87.8% | 0.001 |
| PROBAAT-II | 2016 | Netherlands | 39.7% | 30.2% | ** | <0.001 |
| Gilani et al. | 2018 | Pakistan | 75.0% | ** | 54.17% | 0.033 |
| Al-Ibraheemi et al. | 2018 | USA | 62% | ** | 70% | 0.23 |
| Priyadarshini et al. | 2021 | India | 56.8% | ** | 76% | 0.2 |
| 2023 | Tunisia | 76.66% | 81.42% | 81.42% | 0.70 |
Table 18.
Vaginal delivery rates within 24 hours.
Table 18 highlights the variability in vaginal delivery rates across different studies. While our findings show high success rates for both methods, the slight advantage of the extra-amniotic balloon catheter in our study is consistent with the results from other research.
4.3.3 Oxytocin use
Oxytocin is frequently used to augment labor once cervical ripening has been achieved, particularly when labor is slow to progress. In our study, oxytocin was administered in 63.33% of the Misoprostol group and 68.57% of the extra-amniotic balloon group, with no significant differences between the groups. These findings are consistent with studies by Aduloju et al. [24] and PROBAAT-II [22], where oxytocin use was equally common across various induction methods [20, 24].
The similar rates of oxytocin use suggest that both methods are equally effective in achieving adequate uterine contractions. However, obese women and those with unfavorable Bishop scores may require higher doses of oxytocin to reach the same labor progression as other women, as noted by studies on labor induction in obese populations (Table 19) [10, 27].
| Study | Year | Country | Misoprostol (%) | Foley catheter (%) | Combined (%) | p-Value |
|---|---|---|---|---|---|---|
| Lanka et al. | 2014 | India | 46.03 | ** | 46.03 | 0.37 |
| Aduloju et al. | 2016 | Nigeria | 61.4 | 94.2 | 31.4 | 0.001 |
| Levine et al. | 2016 | USA | 68.6 | 89.9 | 70.7 | <0.001 |
| PROBAAT-II | 2016 | Netherlands | 68.4 | 80.3 | ** | <0.001 |
| 2023 | Tunisia | 63.33 | 68.57 | 68.57 | 0.75 |
Table 19.
Oxytocin use.
Table 19 summarizes oxytocin usage in different studies. Our findings align with other research, where both methods of cervical ripening necessitate similar levels of oxytocin administration to ensure labor progression.
4.4 Evaluation of potential morbidities
4.4.1 Maternal complications
In terms of maternal complications, our study found that uterine tachysystole occurred in 6% of women induced with Misoprostol, a rate comparable to other studies, including those by Aregeb et al. [17] and Kehl et al. [12, 13]. No cases of uterine rupture were reported in our cohort, which is consistent with the findings of Kehl et al. [12], who also reported low rates of uterine rupture with mechanical methods [12].
The low rate of maternal complications in our study aligns with international standards for cervical ripening techniques, particularly when these methods are used in women without prior uterine surgery [13].
4.4.2 Neonatal complications
Neonatal outcomes were similarly favorable in both groups. The rates of neonatal admission to intensive care units (NICU) were low, and there were no significant differences in Apgar scores at 1 and 5 minutes between the groups. This aligns with the findings of studies like those by Carbone et al. [28] and Levine et al. [25], which reported no significant differences in neonatal outcomes based on the method of cervical ripening [27].
In our study, there were no cases of neonatal death, and the few neonates who required NICU admission were primarily from mothers induced with Misoprostol. This pattern, while not statistically significant, mirrors findings in studies like those by Al-Ibraheemi et al. [27], where Misoprostol was associated with slightly higher rates of neonatal distress compared to mechanical methods. However, these differences were minor and did not result in long-term adverse outcomes [20, 25].
4.5 Limitations and strengths of the study
4.5.1 Study limitations
Sample size : Although our study included 100 patients, this sample size may be insufficient to detect rare outcomes or subtle differences between the two methods. A larger sample size would allow for more robust conclusions, especially regarding rare complications like uterine rupture.Study design : This was a retrospective observational study, which limits the ability to establish causality. Randomized controlled trials would provide stronger evidence of the relative efficacy and safety of the two methods.Methods of ripening : Our study focused on two specific methods of cervical ripening, namely the extra-amniotic balloon catheter and Misoprostol. Other methods, such as prostaglandin gels or oral Misoprostol, were not evaluated, potentially limiting the generalizability of our findings to other clinical settings.
4.5.2 Study strengths
Recent data : Our study is based on recent data, reflecting current clinical practices in labor induction. This ensures that our findings are relevant to contemporary obstetric care.Diversity of methods : By comparing two commonly used methods of cervical ripening, our study provides valuable insights into their relative effectiveness and safety, helping inform clinical decision-making in everyday practice.Clinical relevance : The findings of our study are directly applicable to clinical practice, particularly in resource-limited settings like Tunisia, where cost-effective and efficient labor induction methods are essential.
5. Conclusions
The artificial induction of labor (DAT) is a procedure designed to initiate labor before its natural onset, distinct from cervical ripening, which is often required beforehand. Successful induction typically leads to vaginal delivery, though the time to achieve this can vary. The decision to proceed with induction must be made collaboratively between the patient and healthcare provider, ensuring all available resources are used for a safe delivery.
In Tunisia, Misoprostol is frequently used for cervical ripening despite lacking AMM for third-trimester use. The extra-amniotic balloon catheter is also widely employed, reflecting local practices despite guidelines advising against its use in some countries.
Our study aimed to describe the epidemiological profile of women requiring cervical ripening and to evaluate outcomes using mechanical and chemical methods. The study, conducted with 100 women at a Tunisian maternity center, focused on vaginal delivery rates and other outcomes such as labor duration, maternal, and neonatal complications.
Key findings showed that Misoprostol and the extra-amniotic catheter were effective in cervical ripening, facilitating vaginal deliveries in most cases. However, safety concerns have been raised regarding Misoprostol’s use, and the extra-amniotic catheter is not recommended by some health authorities, highlighting the need for cautious administration to prioritize maternal and fetal safety.
Acknowledgments
The authors would like to express their sincere gratitude to the obstetric gynecology department "D" at the Center de Maternité et de Néonatologie de Tunis (CMNT) for their support and assistance during the course of this study. Special thanks to Dr. Dalenda Chelli and the medical team for their invaluable insights and contributions.
Parts of this chapter were previously published in the doctoral thesis by the same author: Montacer Hafsi, Faculty of Medicine of Tunis, University Tunis El Manar. The author acknowledges the use of Grammarly AI for language polishing of the manuscript.
Conflict of interest
The authors declare no conflict of interest.
Notes
The authors extend their appreciation to all the healthcare professionals who participated in the data collection process and to the patients whose cooperation was essential for the completion of this study.
References
- 1.
Robinson D, Campbell K, Hobson SR, et al. Guideline no. 432b: Cervical ripening. Journal of Obstetrics and Gynaecology Canada. 2023; 45 (1):56-62 - 2.
National Institute for Health and Care Excellence. Inducing Labour: NICE Guidance. 2023. Available from: https://www.nice.org.uk/guidance/ng207/history - 3.
Haute Autorité de Santé. Synthèses des recommandations professionnelles: Déclenchement artificiel du travail à partir de 37 semaines d’aménorrhée. Revue Sage Femme. 2009; 8 (1):14-18. Available from:https://www.sciencedirect.com/science/article/abs/pii/S1637408808002411 - 4.
Ducloy Bouthors AS, Keita Meyer H, Bouvet L, et al. Accouchement normal: Accompagnement de la physiologie et interventions médicales. Gynécologie Obstétrique Fertilité & Sénologie. 2020; 48 (12):891-906 - 5.
Dore S, Ehman W. No. 396: Intrapartum consensus guideline. Journal of Obstetrics and Gynaecology Canada. 2020; 42 (3):316-348 - 6.
Trabelsi H, Mathlouthi N, Zayen S, et al. Maturation cervicale à terme: Étude prospective randomisée: Misoprostol versus dinoprostone. La Tunisie Médicale. 2011; 90 (5):362-369 - 7.
American College of Obstetricians and Gynecologists. Obstetric care consensus no. 11: Pregnancy at age 35 years or older. Obstetrics and Gynecology. 2023; 141 (5):1030 - 8.
Ellis JA, Brown CM, Barger B, et al. Influence of maternal obesity on labor induction: A systematic review. Journal of Midwifery & Women’s Health. 2019; 64 (1):55-67 - 9.
Rydahl E, Declercq E, Juhl M, et al. Cesarean section on the rise: Does advanced maternal age explain the increase? PLoS ONE. 2019; 14 (1) - 10.
Roloff K, Peng S, Sanchez Ramos L, et al. Cumulative oxytocin dose during induction of labor according to maternal body mass index. International Journal of Gynaecology and Obstetrics. 2015; 131 (1):54-58 - 11.
Richards MK, Flanagan MR, Littman AJ, et al. Primary cesarean section and adverse delivery outcomes among women of very advanced maternal age. Journal of Perinatology. 2016; 36 (4):272-277 - 12.
Kehl S, Weiss C, Rath W. Balloon catheters for induction of labor at term after previous cesarean section: A systematic review. European Journal of Obstetrics, Gynecology, and Reproductive Biology. 2016; 204 :44-50 - 13.
Gilani S, Ain QT, Hanif M, Mazhar SB, Saeed N. Concurrent use of intracervical Foley’s catheter plus vaginal misoprostol versus vaginal misoprostol alone for induction of labour. Journal of the Society of Obstetrics and Gynaecologists of Pakistan. 2018; 8 (3):184-190 - 14.
Leelarujijaroen C, Pruksanusak N, Geater A, et al. A predictive model for successfully inducing active labor among pregnant women: Combining cervical status and clinical characteristics. European Journal of Obstetrics & Gynecology and Reproductive Biology: X. 2023; 18 :100196 - 15.
Diaz Martinez A, Monfort Ortiz R, Ye Lin Y, Garcia Casado J, Nieto Tous M, Nieto Del Amor F, et al. Uterine myoelectrical activity as biomarker of successful induction with dinoprostone: Influence of parity. Biocybernetics and Biomedical Engineering. 2023; 43 (1):142-156 - 16.
Batinelli L, Serafini A, Nante N, et al. Induction of labor: Clinical predictive factors for success and failure. Journal of Obstetrics and Gynaecology. 2018; 38 (3):352-358 - 17.
Aregeb ZA, Albromboly W, Abdelhameid AA, Helal KF, Badr MS. Induction of labor using vaginal misoprostol alone or combined with intracervical Foley catheter. Egyptian Journal of Hospital Medicine. 2021; 85 (1):3125-3129 - 18.
Priyadarshini A, Jaiswar SP, Singh A, Singh S. Comparative outcome of induced labor by intracervical Foley catheter with misoprostol versus misoprostol alone. Journal of Comparative Effectiveness Research. 2019; 8 (1):55-59 - 19.
Ellis JA, Brown CM, Barger B, Carlson NS. Influence of maternal obesity on labor induction: A systematic review and meta analysis. Journal of Midwifery & Women’s Health. 2019; 64 (1):55-67 - 20.
Osoti A, Kibii DK, Tong TMK, et al. Effect of extra amniotic Foley’s catheter and vaginal misoprostol versus vaginal misoprostol alone on cervical ripening and induction of labor in Kenya: A randomized controlled trial. BMC Pregnancy and Childbirth. 2018; 18 (1):300 - 21.
Ten Eikelder MLG, Neervoort F, Oude Rengerink K, Van Baaren GJ, Jozwiak M, De Leeuw JW, et al. Induction of labour with a Foley catheter or oral misoprostol at term: The PROBAAT-II study, a multicentre randomised controlled trial. BMC Pregnancy and Childbirth. 2013; 13 :67 - 22.
Ten Eikelder MLG, Oude Rengerink K, Jozwiak M, De Leeuw JW, De Graaf IM, Van Pampus MG, et al. Induction of labour at term with oral misoprostol versus a foley catheter (PROBAAT-II): A multicentre randomised controlled non inferiority trial. Lancet. 2016; 387 (10028):1619-1628 - 23.
Lanka S, Surapaneni T, Nirmalan PK. Concurrent use of foley catheter and misoprostol for induction of labor: A randomized clinical trial of efficacy and safety: Induction of labor. Journal of Obstetrics and Gynaecology Research. 2014; 40 (6):1527-1533 - 24.
Aduloju OP, Akintayo AA, Adanikin AI, et al. Combined Foley’s catheter with vaginal misoprostol for pre-induction cervical ripening: A randomized controlled trial. The Australian & New Zealand Journal of Obstetrics & Gynaecology. 2016; 56 (6):578-584 - 25.
Levine LD, Downes KL, Elovitz MA, et al. Mechanical and pharmacologic methods of labor induction: A randomized controlled trial. Obstetrics and Gynecology. 2016; 128 (6):1357-1364 - 26.
Inamdar S, Toshniwal SM, Sharma SR. Foley’s catheter and vaginal misoprostol vs vaginal misoprostol alone for labor induction. Journal of South Asian Federation of Obstetrics and Gynaecology [En ligne]; 14(4):7 p. Consultable à l’URL: https://www.jsafog.com/doi/10.5005/jp-journals-10006-2094 2022 [Consulté le 29 janvier 2023] - 27.
Al-Ibraheemi Z, Brustman L, Bimson BE, et al. Misoprostol with Foley bulb compared with misoprostol alone for cervical ripening: A randomized controlled trial. Obstetrics and Gynecology. 2018; 131 (1):23-29 - 28.
Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: A randomized controlled trial. Obstetrics and Gynecology. 2013; 121 (2):247-252