Maira Khan 1, Saima Khattak 2*
Author affiliations:
- Maira Khan, Medical Officer, Department of Obstetrics & Gynecology, Medical Teaching Institution, Lady Reading Hospital, Peshawar, Pakistan; E-mail; butterfly20192@gmail.com
- Saima Khattak, Assistant Professor, Department of Obstetrics & Gynecology, Medical Teaching Institution, Lady Reading Hospital, Peshawar, Pakistan; E-mail: dr_saima_79@yahoo.com
Correspondence: Dr. Saima Khattak,
E-mail: dr_saima_79@yahoo.com;
Phone: + 92 3005878068
ABSTRACT
Background & Objective: Premature rupture of the membranes (PROM) is defined as rupture of the membranes (amniotic sac) before the commencement of the labor and after 37 weeks gestation. Opinions differ whether to induce labor in these parturients or continue to manage conservatively. The purpose of this research was to compare the incidence of unfavorable fetal outcomes in cases of early rupture of the membranes and expectant treatment in the induction of labor.
Methodology: This randomized controlled trial was conducted at the Department of Obstetrics & Gynaecology, Lady Reading Hospital, Peshawar, from 1st August 2022 to 31st January 2023. A total of 610 pregnant women with PROM were included in the study. In total, 305 patients were in the expectant management group or Group A, while 305 patients were in induction of labor or Group B. After delivery, fetal outcomes (birth asphyxia, low Apgar score, and sepsis) were noted and compared in both groups.
Results: Birth Asphyxia was observed in 69 (22.6%) patients in Group A as compared to 44 (14.4%) patients in Group B (P = 0.009). A low Apgar Score was observed in 27 (8.9%) patients in Group A compared to 10 (3.3%) patients in Group B (P = 0.004). Sepsis was observed in 8 (2.6%) patients in Group A as compared to 1 (0.3%) patient in Group B (P = 0.019).
Conclusion: It is concluded that all patients presenting with premature rupture of membranes at term should be actively managed with induction of labor.
Keywords: Pregnancy; Premature rupture of membranes; Labor induction; Expectant management; Adverse fetal outcomes
Citation: Khan M, Khattak S. Comparison of induction of labor versus conservative management in premature rupture of membranes on fetal outcome. Anaesth. pain intensive care 2024;28(3):541−546; DOI:
10.35975/apic.v28i3.2470
Received: March 08, 2024;
Reviewed: May 01, 2024;
Accepted: May 05, 2024
1. INTRODUCTION
A crucial point in any pregnancy is known as premature rupture of the membranes (PROM), which happens when the membranes burst before labor begins, generally after the 37th week of gestation.
1 PROM is caused by a variety of factors, ranging from extrinsic factors like tobacco use and low socioeconomic level to physiological alterations like programmed cell death.
2,3 Premature rupture is linked to 30–40% of premature births, which accounts for a high morbidity and death of newborns.
4,5
Preterm premature rupture of membranes (PPROM) complicates around 3% of pregnancies in the US each year; thus, managing and treating this condition is still critical.
6,7 In times of uncertainty, novel diagnostic methods utilizing biochemical markers such as placental alpha-microglobulin-1 have demonstrated encouraging sensitivity and specificity, assisting in accurate diagnosis and subsequent treatment choices.
8
Emerging data points to a move away from expectant management and toward labor induction in the context of divergent methods of controlling postpartum hemorrhage.
9 Research comparing expectant management versus induction of labor in women with PROM, such as done by Hannah et al., showed that induction techniques decreased the risk of maternal infections but showed equal rates of cesarean deliveries.
10 Furthermore, it has been documented that women have more positive opinions of induction than expectant management.
10
The decision between expectant management and induction, however, impacts the fetal health.
11 Nath et al. discovered significant variations in unfavorable fetal outcomes in patients with PROM between expectant care and induction of labor, highlighting different rates of birth hypoxia, poor Apgar scores, and infection; underscoring the necessity for a thorough comparison.
12
The need to quickly determine the best course of action for controlling postpartum hemorrhage (PPH), considering the possible hazards connected to both expectant management and labor induction, was the driving force behind this investigation. Careful consideration must be given to the possibility of poor fetal outcomes because of induction failure or hyperstimulation. Therefore, we assessed the incidence of poor fetal outcomes between expectant management and labor induction for patients who had PROM.
2. METHODOLOGY
2.1. Study particulars
It was a randomized controlled trial conducted at the Lady Reading Hospital, Peshawar, from August 1, 2022, to January 31, 2023. It involved 610 pregnant women with PROM. Randomization and double blinding were achieved using computer-generated random numbers, which helped in minimizing selection bias and achieving comparable groups. Participants were randomly assigned to either the expectant management group (Group A, n = 305) or the induction of labor group (Group B, n = 305). Data on fetal outcomes, including birth asphyxia, low Apgar score and sepsis, were collected post-delivery.
2.2. Sample size / sampling technique
The predicted sample size of 617 patients—305 in each group—was calculated using 80% test power and a 5% significance threshold to guarantee statistical significance. Non-probability sequential sampling was used to choose participants.
The calculation utilized a formula commonly employed for comparing two independent proportions in clinical trials. This formula incorporates factors such as the desired significance level (α), power (β), and estimated proportion of the population with the characteristic of interest. Raosoft online calculator was used for such calculations. Additionally, non-probability sequential sampling was employed to select participants based on convenience or availability when random selection was impractical or impossible. The calculation was based on the following formula;
n is the required sample size,
Z-score (for 95%, ≈1.96 Z≈1.96).
p is the estimated population.
E = standard error (0.5).
The sample calculated was 384 and after removing the participants with missing data, the end sample size for each group was 305 for each group.
2.3. Study population
The women included in the study were 18-35 y of age, had ultrasound proof of a singleton pregnancy, had a gestational age of more than 36 weeks according to LMP, had a parity between 0 and 4, and met the operational criteria for preterm rupture of the membranes. Cases of meconium aspiration syndrome, cephalopelvic disproportion, intrauterine fetal mortality on ultrasonography, malpresentation, and moms with PROM who had previously taken antibiotics before delivery as documented in medical records, were excluded. The 610 eligible patients or their guardians gave their informed consent. The institutional ethics committee granted approval for the study.
2.4. Data collection procedure
Age, gestational age, and parity were among the documented demographic data. Group A patients were observed for twenty-four hours using a sterile vulval pad to wait for spontaneous labor to begin. Limited vaginal exams were performed until absolutely required to evaluate the state of labor. If contractions did not start within 24 h, labor induction took place. LSCS was used in an emergency based on specific indications including fetal distress, failed induction of labor, maternal complications such as hemorrhage or hypertensive disorders, or other clinical factors necessitating urgent delivery to ensure the safety and well-being of both the mother and the baby.
Induction of labor patients (Group B) were inducted based on Bishop's pre-induction score. Intravenous oxytocin or PGE1 tablets were used, with dose adjustments made until effective uterine contractions were obtained. Fetal outcomes, including birth hypoxia, low Apgar scores, and sepsis, were documented on a specified proforma and annotated using predetermined criteria after delivery.
2.5. Data analysis
IBM SPSS version 22 (IBM Corporation. New York, USA) was used for data analysis; mean ± SD for quantitative variables and frequency/percentage for qualitative variables are presented. The results were compared between groups using the Chi-square test (P ≤ 0.05 deemed significant). Age, parity, and gestational age stratification were used to evaluate their effect on outcomes using post-stratification chi-square testing for significance (P < 0.05).
3. RESULTS
The demographic profile of the two participant groups, A and B, each with 305 individuals, is shown in Table 1. Group B has a slightly higher mean age. In terms of gestational age. Group B has a slightly higher mean gestational age (P = 0.353). Both groups have similar sample sizes, and only minor age and gestational age differences are displayed.
Table 1 also shows the distribution of parity in Group A and Group B. Parity, determined by the number of prior pregnancies, shows interesting variations between the groups. The results show significant differences in the groups' parity distributions: Group B is more represented in higher parities, especially parity 3, whereas Group A has a higher percentage of nulliparous people (parity 0).
Table 1: Comparison of age, gestational age (weeks) and parity of the participants |
Parameters |
Group A
(n = 305) |
Group B
(n = 305) |
P-value |
Age (y) |
27.800 ± 2.39 |
28.531 ± 2.34 |
0.000 |
Gestational age (weeks) |
38.429 ± 1.12 |
38.511 ± 1.16 |
0.353 |
Parity |
0 |
80 (26.2) |
47 (15.4) |
0.000 |
1 |
91 (29.8) |
83 (27.2) |
2 |
83 (27.2) |
84 (27.5) |
3 |
34 (11.1) |
72 (23.6) |
4 |
17 (5.6) |
19 (6.2) |
Data presented as mean ± SD or n (%) |
Total birth-related complications including the frequency of birth asphyxia, low apgar score, and sepsis in Groups A and B in relation to age group, parity and gestational age are compared in groups in Table 2, 3 and 4. In comparison to Group B, Group A showed significantly greater incidence of sepsis (P = 0.019), low Apgar score (P = 0.004), and birth asphyxia (P = 0.009).
Table 2: Comparative birth asphyxia complication in Groups A and B; [n (%)] |
Variable |
Group A
(n = 305) |
Group B
(n = 305) |
P-value |
Total birth asphyxia |
69 (22.6) |
44 (14.4) |
0.009 |
Age group |
18-30 (y) |
55 (21.4) |
28 (12.6) |
0.010 |
> 30 (y) |
14 (29.2) |
16 (19.5) |
0.207 |
Parity |
0-2 |
52 (20.5) |
26 (12.1) |
0.016 |
3-4 |
17 (33.3) |
18 (19.8) |
0.072 |
Gestational age |
36-39 weeks |
58 (22.9) |
39 (15.3) |
0.029 |
> 39 weeks |
11 (21.2) |
5 (10) |
0.122 |
Table 3: Comparative low Apgar score in Groups A and B; [n (%)] |
Variable |
Detail |
Group A
(n = 305) |
Group B
(n = 305) |
P-value |
Low Apgar score (total) |
27 (8.9) |
10 (3.3) |
0.004 |
Age group |
18-30 y |
22 (8.6) |
9 (4) |
0.044 |
> 30 y |
5 (10.4) |
1 (1.2) |
0.016 |
parity |
0-2 |
20 (7.9) |
9 (4.2) |
0.101 |
3-4 |
7 (13.7) |
1 (1.1) |
0.001 |
Gestational age |
36-39 weeks |
21 (8.3) |
6 (2.4) |
0.002 |
> 39 weeks |
6 (11.5) |
4 (8) |
0.548 |
Table 4: Comparative sepsis complications in Groups A and B; [n (%)] |
Variable |
Detail |
Group A
(n = 305) |
Group B
(n = 305) |
P-value |
Sepsis (Total) |
8 (2.6) |
1 (0.3) |
0.019 |
Age group |
18-30 y |
7 (2.7) |
0 (0) |
0.013 |
> 30 y |
1 (2.1) |
1 (1.2) |
0.699 |
parity |
0-2 |
7 (2.8) |
0 (0) |
0.014 |
3-4 |
1 (2) |
1 (1.1) |
0.675 |
Gestational age |
36-39 weeks |
7 (2.8) |
1 (0.4) |
0.031 |
> 39 weeks |
1 (1.9) |
0 (0) |
0.324 |
When birth asphyxia is broken down by maternal age, significantly low Apgar scores were found in the >30 age group (P = 0.016), and for ages 18–30 (P = 0.010) and >30 (P = 0.207). Birth Asphyxia varies across parities 0–2 (P = 0.016), and there is a difference in birth asphyxia between gestational ages 36–39 weeks (P = 0.029) as shown in Table 2.
Low Apgar scores were observed significantly more in Group A compared to Group B regarding age group, parity as well as in mothers with gestational age of 36-39 weeks (P = 0.002) (Table 3).
Regarding sepsis the frequency was significantly higher in Group A in 18-30 (y) age group (P = 0.013), Para 0-2 (P = 0.014), and gestational age 36-39 weeks (P = 0.031) (Table 4).
4. DISCUSSION
The mean maternal age, gestational age, and parity of the women in Group A (the expectant management group) and Group B (the induced group) were similar in our research. Given the similarity of their socio-demographic profiles, variations in management techniques rather than demographic disparities were the primary cause of any observed differences in outcomes between these two groups. Significant findings from the study indicate a notable reduction in adverse fetal outcomes, including lower rates of birth asphyxia, low Apgar scores, and sepsis, among patients managed with induction of labor compared to those undergoing expectant management for premature rupture of membranes (PROM). In our investigation, we found that 44 patients in Group B experienced birth asphyxia (14.4%), whereas 69 patients in Group A (22.6%) experienced it (P = 0.009). Compared to 10 (3.3%) patients in Group B, 27 (8.9%) patients in Group A had low Apgar scores (P = 0.004). Compared to 1 (0.3%) patient in Group B, sepsis was seen in 8 (2.6%) patients in Group A (P = 0.019). The findings of my research are consistent with a study by Nath et al
., which found that poor Apgar scores were 8% vs 4%, sepsis was 2% against 0%, and the frequency of birth asphyxia was 28% in expectant management compared to 16% with induction of labor in PROM patients.
12
According to research by Shanti et al.
, the predicted group's LSCS rate was 5.7%, whereas the active group's rate was 12%.
13 Another research by Suneela et al
., found that 88.3% of expecting women had birth vaginally, compared to 85.0% of active management women. This means that the expectant group had an LSCS rate of 11.7%, whereas the induced group had a rate of 15%.
14
In a study by Suneela et al. 3.3% and 5%, of the induced and expectant groups respectively, developed pyrexia. In another study, Sumaira et al., (Peshawar) reported 2.4% fever, but in the expectant group, it was 16.0%.
14 According to Suneela et al
., 108's study, 6.6% of the expecting group experienced severe delivery hypoxia that required ventilation, while 11.7% of the expectant group experienced neonatal sepsis.
14
Reducing the latent period and improved mother satisfaction are just two of the many advantages of active therapy in cases with PROM at term.
15 In these situations, inducing labor not only shortens the PROM-delivery time but also lowers the risk of sepsis in both the mother and the newborn without significantly increasing the LSCS rate.
16 It is evident that within 24 h, around 70% of term PROM patients experience spontaneous labor without an intervention.
14 Based on the cervical findings or Bishop's pre-induction score, either oxytocin or PGE1 (misoprostol) is used during induction.
17
The key end measures of the current study showed that the induction group had considerably shorter time to delivery, a significantly greater rate of cesarean sections, and equivalent rates of maternal and newborn morbidity.
18 The expecting group's secondary result is that their need for oxytocin augmentation is not considerably raised, and their PGE1 pill dosage is significantly lower. The expectant group's hospital stay was longer than that of the early induction group.
5. LIMITATIONS
Our study was limited to one hospital only, with limited age range and specific medical conditions, which limited its wider applicability. There could be potential observer bias in clinical assessments like Apgar scores and sepsis. The study was restricted to short-term outcomes, overlooking long-term maternal and fetal impacts.
Reliance on medical records risks inaccuracies due to documentation related variabilities.
6. CONCLUSION
This study concluded that inducing labor in parturients with premature rupture of the membranes (PROM) at term resulted in a shorter PROM delivery interval, dramatically improved mother satisfaction, and improved fetomaternal outcomes. Patients felt worry and anguish due to the increased rates of maternal and fetal morbidity and sepsis in the expecting group that received conservative care. We recommend that to lower the risk of maternal and fetal morbidity, all patients who present with premature rupture of the membranes at term should be actively handled with induction of labor following cervical status assessment using Bishop's Pre-Induction score.
7. Data availability
The numerical data generated during this research is available with the authors.
8. Acknowledgement
We gratefully thank faculty and staff of the Department of Obstetrics & Gynecology, Medical Teaching Institution, Lady Reading Hospital, Peshawar, Pakistan for their full cooperation during the conduct of this study.
9. Conflict of interest
The study utilized the hospital resources only, and no external or industry funding was involved.
10. Ethical considerations
The ethics committee of Lady Reading Hospital, Peshawar granted approval for the study. Written informed consent was obtained from every participant.
Authors’ contribution
Both authors took equal part in th, conduct of the study, data collection, statistical analysis, and manuscript preparation.
11. REFERENCES
- Garg A, Jaiswal A. Evaluation and Management of Premature Rupture of Membranes: A Review Article. Cureus. 2023;15(3):e36615. [PubMed] DOI: 7759/cureus.36615
- Enjamo M, Deribew A, Semagn S, Mareg M. Determinants of Premature Rupture of Membrane (PROM) Among Pregnant Women in Southern Ethiopia: A Case-Control Study. Int J Womens Health. 2022;14:455-466. [PubMed] DOI: 2147/IJWH.S352348
- Assefa NE, Berhe H, Girma F, Berhe K, Berhe YZ, Gebreheat G, et al. Risk factors of premature rupture of membranes in public hospitals at Mekele city, Tigray, a case control study. BMC Pregnancy Childbirth. 2018;18(1):386. [PubMed] DOI: 1186/s12884-018-2016-6
- Jena BH, Biks GA, Gete YK, Gelaye KA. Incidence of preterm premature rupture of membranes and its association with inter-pregnancy interval: a prospective cohort study. Sci Rep. 2022;12(1):5714. [PubMed] DOI: 11038/s41598-022-09743-3
- Muhe LM, McClure EM, Nigussie AK, Mekasha A, Worku B, Worku A, et al. Major causes of death in preterm infants in selected hospitals in Ethiopia (SIP): a prospective, cross-sectional, observational study. Lancet Glob Health. 2019;7(8):e1130. [PubMed] DOI: 1016/S2214-109X(19)30220-7
- Menon R, Richardson LS. Preterm prelabor rupture of the membranes: A disease of the fetal membranes. Semin Perinatol. 2017;41(7):409-419. [PubMed] DOI: 1053/j.semperi.2017.07.012
- Herzlich J, Mangel L, Halperin A, Lubin D, Marom R. Neonatal outcomes in women with preterm premature rupture of membranes at periviable gestational age. Sci Rep. 2022;12(1):11999. [PubMed] DOI: 1038/s41598-022-16265-5
- Feduniw S, Gaca Z, Malinowska O, Brunets W, Zgliczyńska M, Włodarczyk M, et al. The Management of Pregnancy Complicated with the Previable Preterm and Preterm Premature Rupture of the Membranes: What about a Limit of Neonatal Viability?-A Review. Diagnostics. 2022;12(8):2025. [PubMed] DOI: 3390/diagnostics12082025
- Masuzawa Y, Kataoka Y, Fujii K, Inoue S. Prophylactic management of postpartum haemorrhage in the third stage of labour: an overview of systematic reviews. Syst Rev. 2018;7(1):156. [PubMed] DOI: 1186/s13643-018-0817-3
- Bachar G, Shemesh D, Farago N, Siegler Y, Khatib N, Ginsberg Y, et al. The optimal induction timing in prelabor rupture of membranes: a retrospective study. J Matern Fetal Neonatal Med. 2023;36(1):2215997. [PubMed] DOI: 1080/14767058.2023.2215997
- Wennerholm UB, Saltvedt S, Wessberg A, Alkmark M, Bergh C, Wendel SB, et al. Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS): multicentre, open label, randomised, superiority trial. BMJ. 2019;367:l6131. [PubMed] DOI: 1136/bmj.l6131
- Njie AE, Nyandiko WM, Ahoya PA, Moutchia JS. A comparative analysis of APGAR score and the gold standard in the diagnosis of birth asphyxia at a tertiary health facility in Kenya. PLoS One. 2023;18(5):e0285828. [PubMed] DOI: 1371/journal.pone.0285828
- Shanthi DK, Devi DGP, Bharathi DT, Chandrasekharan DPA. Comparative study of Active versus Expectant management and Maternal and Neonatal outcome in Premature rupture of the membranes ( PROM ) in Tertiary Care Hospital , Tirupathi. 2015; 2015.
- Kolluri S. Prelabour rupture of membranes at term: Expectant Management vs Induction of labour. Sch J App Med Sci. 2016;4(4D)1424-7. [FreeFullText]
- Cameron NJ, Wertaschnigg D, Davey MA, Burger RJ, Mol BW, Woolner AM. Incidence and management of premature rupture of membranes in Victoria, Australia: A retrospective cohort study of 636 590 births between 2009 and 2017. Aust N Z J Obstet Gynaecol. 2023. [PubMed] DOI: 1111/ajo.13773
- Ghafoor S. Current and Emerging Strategies for Prediction and Diagnosis of Prelabour Rupture of the Membranes: A Narrative Review. Malays J Med Sci. 2021;28(3):5. [PubMed] DOI: 21315/mjms2021.28.3.2
- Berma A, Ray A, Bhattacharya NN, Basu K, Kumar B, Sarkar SK. Expectant versus active management in term prelabor rupture of membranes (PROM)-a prospective study in a tertiary care hospital. New Indian J OBGYN. 2019;6(1):36-41. DOI: 21276/obgyn.2019.6.1.9
- Pintucci A, Meregalli V, Colombo P, Fiorilli A. Premature rupture of membranes at term in low risk women: how long should we wait in the “latent phase”? J Perinat Med. 2014;42(2):189-196. [PubMed] DOI: 10.1515/jpm-2013-0017