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Annals of Medicine and Medical Sciences
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  2. Vol. 05, No. 09, (2026)
  3. A Study on Management of Premature Rupture of Membrane at a Tertiary C…
Original Article Open Access

A Study on Management of Premature Rupture of Membrane at a Tertiary Care Teaching Hospital in Kolkata

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Annals of Medicine and Medical SciencesVol. 05, No. 09, (2026) September 16, 2026pp. 2211 - 2216
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Abstract

Background: Premature rupture of membrane (PROM) is a potential issue when amniotic sac ruptures before labour commences. The central concern in terms of PROM is whether mothers can enter the labour spontaneously or labour needs to be induced as there is a considerable mother's vulnerability of intra - uterine infection affecting the health outcome of mothers and newborns. The effects of planned early birth versus expectant management on fetal, infant and maternal well-being for mothers with PROM must therefore be evaluated. Methods: A prospective observation study was conducted at a tertiary care teaching hospital in Kolkata keeping in mind the background of effect of management of different PROM patients. Study design and methodology was approved by Institution Ethics committee and patients were enrolled in the study during the study period of Jun 2018 to July 2019. All data were collected, analysed among subsets of study group on different parameter like age, sex, gravida, parity, mode of delivery, APGAR score, Neonatal sepsis, NICU Admission etc. etc using appropriate statistical test. Patients were followed up in puerperium for 48 hours for any maternal morbidity. Results: Out of the total 210 women, 105 women each were allocated in induction and expectant management category. There were no statistically significant difference between the two groups in respect of baseline and demographic characteristics. The PROM to delivery interval and neonatal morbidities showed significant difference among the study groups. PROM delivery interval for 24 hours among induction category and expectant category were 42.8%, 52.4%, 4.8% and 10.5%, 69.5%, 20% respectively. In the expectant management cohort the caesarean delivery (LSCS) was delivery method for 12.4 %, particularly in comparison to a clinically significant 20% in the women subjected to induction method. Conclusion: This prospective observational study showed that there were significant difference in caesarean delivery rate between expectant management group and induction group of patient with PROM. Different neonatal outcome among expectant management group was higher and were statistically significant if compared with induction group.

Keywords

PROM LSCS Induction of labour Expectant management.

Introduction

Premature rupture of membrane (PROM) is a clinical scenario that occurs in 8-10% of case scenarios when the amniotic membrane starts leaking at term before the commencement of labour [1,2]. Only when labour really isn't induced, more than 60% of these mothers will instantaneously commence labour within 24 hours and even more than 95% will go in labour spontaneously before 72 hours [3,4]. However, in remaining cases, this may be delayed up to 7 days after membrane rupture [5]. The likelihood of mother and neonatal infection tends to increase when the period between membrane rupture as well as the onset of labour rises. Nowadays, many clinicians advise inducing labour if the pregnancy is at term and labour does not commence instantaneously fairly soon just after rupture. Another viewpoint supports expectant management with the use of a reduced risk of LSCS delivery if there is no substantiation of fetal or maternal compromise. PROM during a term period can lead impending complications like cord prolapse, cord compression, and placental abruption, as well as future complications such as maternal and new-born infection with the use of interventions like the caesarean or instrumental vaginal birth. The risk of mother and new-born infections rises as the period between rupture of membranes and delivery of the new-born rises. The danger of ascending infections, which can cause maternal - fetal morbidity and mortality, is frequently interpreted as a sign to hasten delivery [4,6]. Furthermore, intrauterine life in the presence of ruptured membranes for longer than 24 hours has been identified as a risk factor for later handicap [7]. PROM takes place in the vast majority of instances (90%) in mothers are at term [8], and PROM at period usually happens in 8% among all babies born [2].

The primary concern in managing these patients would be to either let everyone to go into labor spontaneously or to induce labor because there is a considerable mother’s likelihood of intra - uterine infectious disease, which is a potentially lethal consequence with PROM for both the mother and the newborn. As a consequence, it is necessary to compare the impact of scheduled induced delivery than spontaneous labour by expectant management for mothers with premature rupture of membrane at term on fetal, new-born, and mother's well-being. Several researches on the treatment modalities for pregnant women with PROM, such as Bezircioglu et al.,[9] Krupa et al.,[10] Meikle et al.,[11] asserted that active management by induction, regardless of cervical condition, is better than expectant management of PROM. Active management reduces mothers and newborns comorbidities and, as a consequence, hospital stay without altering the proportion of LSCS delivery. On the other hand studies like Chung et al.,[12] concluded that except for achieving an earlier delivery, early intervention does not benefit the mother or the baby. In this background keeping in mind we conducted the following study.

Materials and Methods

Aims and Objectives

Primary Objective

To compare the duration of time from premature (prelabour) rupture of membrane to delivery in both the induction and expectant management group

Secondary Objectives

To compare the mode of delivery (spontaneous vaginal delivery/vaginal delivery with instruments/caesarean section), maternal outcome (fever, clinical chorioamnionitis, post partum haemorrhage), neonatal outcome (birth asphyxia, sepsis, NICU admission).

Study Location

R.G. Kar Medical College & Hospital.

Study Population

Patients admitted at term pregnancy with PROM and fulfilling the inclusion criteria in Department of Obstetrics & Gynaecology, R G Kar Medical College and Hospital, Kolkata.

Study Period

One year (July 2018 to June 2019)

Sample Size

Sample size (n) for each arm of the present study was calculated using the results of a study done by Ray and Garite et al.,[13]. The formula used for the calculation was: n= (Zα/2+Zβ)2*2* σ2/d2where, α= Type I error= 5%, β= Power of the Study= 80%. Total requirement of the eligible patients were 210 (105 in each arm). Non-response rate was considered to be 10%.

Sample Selection

Inclusion Criteria

  1. Women at term (gestational age 37 to 40 weeks) having PROM.

  2. Singleton Pregnancy

  3. Pregnancy with Vertex Presentation

Exclusion Criteria

  1. Women less than 37 Weeks of gestation and more than 40 Weeks of gestation.

  2. Women in active labor.

  3. Meconium stained liquor

  4. PROM with chorioamnionitis

  5. Women with medical disorders –Diabetes, Heart diseases complicating pregnancy

  6. Women with obstetric high risk factors like Diabetes, Antepartum haemorrhage, previous caesarean section, Mal presentations etc.

Study Techniques

All patients were selected for the study after obtaining duly informed written consent and duly meeting the inclusion and exclusion criteria of the study. Out of 231 patients admitted and managed during study period, 210 patients consented to participate in the study. All 210 eligible patients were allocated to each of the two management group (Expectant and Induction) in 1:1 fashion during of their inclusion stage of the study. After proper history taking a thorough general, systemic and obstetrical examinations were done. Detail obstetrical examination including per speculum examination done and Bishop’s score calculated. All patients received antibiotics as per protocol of the hospital (2 grams of Ampicillin IV stat followed by tablet Erythromycin 250mg QDS). Patients in the expectant management group were monitored and observed for 24 hours with a sterile vulval pad, waiting for the onset of labor pain. Labour management of the patient were carried out as per institutional protocol. Temperature, pulse rate, uterine pain and contractions, foetal heart rate, colour, and the presence of a foul odour of liquor were all measured. Only if the uterine contraction was adequate was a per vaginal examination performed aseptically. Vaginal examinations that were not essential were omitted. Patients who were allocated to active management were carried out based on their Bishop's scoring system. PGE2 (Dinoprostone gel) was given vaginally if Bishop’s score was <5. PGE2 gel was repeated after 6 hours or IV Oxytocin given as required. If Bishop’s score was >5 IV Oxytocin was started at 5 units in 500 ml of RL. The drop rate was titrated as per the parity till the optimum response was achieved. Temperature, pulse rate, foetal heart rate, uterine contraction, and foetal head drop were all monitored. Spontaneous vaginal, vaginal with instrumental (ventouse/forceps), or LSCS were the modes of delivery. The newborn's Apgar score, birth weight, and requirement for NICU hospitalization were all assessed. If there was any evidence of neonatal sepsis, it was investigated. Patients were monitored for 48 hours during puerperium to see if there was any maternal morbidity.

Plan for Analysis of Data

Depending on the data normality, the continuous variable was evaluated using an independent student T test or a Mann-Whitney Utest. The Chi square test or Fisher exact test were used to assess categorical data, if applicable. The Kaplan and Meier method was used to perform the time to event analysis. Statistical significance is defined as a P value of less than 0.05. MedCalc version 17.9.7 (Mariakerke, Belgium: MedCalc Software 2017) and IBM SPSS Statistics Version 20.0 were used for statistical analysis.

Results

Total 210 pregnant women were included for result and data analysis - out of which 105 women were allocated in each group, namely induction group and expectant management. The majority of the study participants from the both the subgroup of study population were in the age bracket of 20 to 30 years (65.7% expectant group, 60% induction group) and were predominantly Muslim (56.2% expectant group, 54.3% induction group). Most patients were between 39–40 weeks of gestation and had a PROM (Premature Rupture of Membranes) to admission interval of 4–8 hours (60% expectant, 62.9% induction). Most characteristics showed no statistically significant difference between the two groups (p > 0.05), indicating well-matched baseline groups. The same is represented in table No 01.

Table 1 The baseline demographic charasteristics in both the groups
S. No. Baseline Characteristics Distribution Expectant Group Induction Group P-Value
NO % NO %
1. Age Distribution in Years <20 21 20 23 21.9 0.73
20-30 69 65.7 63 60 0.39
>30 15 14.3 19 18.1 0.45
2. Religion Distribution HINDU 46 43.8 48 45.7 0.78
MUSLIM 59 56.2 57 54.3 0.78
3. Gestational Age in Weeks 37 – 37+6 21 20 19 18.1 0.72
38 – 38+6 36 34.3 40 38.1 0.52
39-40 48 45.7 46 43.8 0.76
4. Parity Distribution NULLIPARA 57 54.3 44 41.9 0.07
PRIMIPARA 29 27.6 38 36.2 0.18
P2 & Above 19 18.1 23 21.9 0.49
5. History of Previous Abortion YES 55 52.4 69 65.7 0.05
NO 50 47.6 36 34.3 0.05
6. Prom - Admission Interval <4 HRS 16 15.2 17 16.2 0.85
4-8 HRS 63 60 66 62.9 0.67
>8 HRS 26 24.8 22 20.9 0.51

Abbreviation 1: PROM: Premature Rupture of Membrane

Distribution of Different Categories of Intervals Between PROM and Delivery were evaluated and same is given in Table No 02. A significantly higher proportion of women in the Induction Group delivered in under 12 hours compared to the Expectant Management group (42.8% vs. 10.5%,  p<0.0001 ). Delivery within 12–24 hours was most common in both groups, though higher in the Expectant group (69.5% vs. 52.4%,  p=0.01 ).

Table 2 Distribution of different categories of intervals between prom and delivery
PROM Delivery Interval Expectant Management (n=105) Induction Group (n=105) P-Value
No. % No. %
<12 HRS 11 10.5 45 42.8 <0.0001 #
12-24HRS 73 69.5 55 52.4 0.01 #
>24 HRS 21 20 5 4.8 0.0008 #
Total 105 100 105 100

# Chi-square test

The distribution of mode of delivery is given in Table No 03. LSCS was mode of delivery in 12.4% of women in expectant management group as compared to 20% in Induction group. Fetal distress was the indication for LSCS among both the subgroup. (61.55%of women in expectant management group whereas it was 71.44% in induction group). The results on different indication of LSCS among the study population and subgroup is represented in Table No 04.

Table 3 Different modes of delivery of the study participants
Mode of Delivery Expectant Management Induction Group P Value
No. % No. %
Vaginal Delivery (Spontaneous) 87 82.8 76 72.4 0.069#
Outlet Forceps/ Ventouse 5 4.8 8 7.6 0.39#
LSCS 13 12.4 21 20 0.13#
Total 105 100 105 100

#Chi-square Test

Table 4 Different indications of LSCS between the two groups
Indication of LSCS Expectant Management (n=13) Induction (n=21) P-Value
No. % No. %
Fetal Distress 8 61.55 15 71.44 0.129#
Cephalo Pelvic Disproportion 1 7.69 1 23.80 0.39#
Induction Failure 4 30.76 5 4.76 0.258#
Total 13 100 21 100

#Chi-Square test

Fever as comorbidities were more among the expectant managed group (11.42%) and Post partum Haemorrhage was more common among the Induction group of patient. Details of different maternal morbidities among two groups is represented in Table No 05.

Table 5 Different maternal morbidities between the two groups
Maternal Morbidity Expectant Management Group (n=105) Induction Group (n=105) P-Value
No. % No. %
Fever 12 11.42 4 3.80 0.037#
Chorioamnionitis 10 9.52 3 2.85 0.04#
PPH 8 7.61 13 12.38 0.25#

#Chi-square Test

Abbreviation 1: PPH: Post Partum Haemorrhage

Regarding the Neonatal outcome the study yielded that 26.6 % of neonate got admitted in NICU in expectant management group as compared to 7.62 % in induction group. Sepsis was found in 20 % of neonate in expectant management group as compared to 4.76 % in induction group. In expectant management group 32.38 % of neonate had Apgar score (Apgar-1) <7 and it was only 7.62 % in induction group. The same is represented at Table No 06.

Table 6 Different neonatal outcomes between the two groups
Neonatal Outcome Expectant Management (n=105) Induction Group (n=105) P-Value
No. % No. %
APGAR SCORE 1 <7 34 32.38 8 7.62 <0.0001#
≥7 71 67.62 97 92.38 <0.0001#
Sepsis 21 20 5 4.76 0.0008#
NICU Admission 28 26.6 8 7.61 0.0003#

#Chi-Square test

Discussion

The baseline data, namely age, parity, religion, history of previous abortion and PROM admission interval were comparable in both the groups. In our study the PROM delivery interval was >24 hours in 4.8 % in the induced group compared to 20 % in the expectant group. Kolluri S [14] in her study found that PROM delivery interval was >24 hours in 6.7 % in the induced group as compared to 26.7 % in the expectant group and it corroborates with our study. Shah K et al 10 in their study found it was 12% in induced group compared to 22% in expectant group. Study done by Fabianada Graca Krupa et al.,[15] found that 33.3 % of women delivered within 12 hours in induced group as compared to 14.7 % in the expectant group. Jayati Nath [16] shown in her study that 72 % of women delivered within 12 hours from PROM as compared to only 10 % in the expectant group. In her study, it was observed that only 6% of mothers in the induced cohort had a PROM delivery interval of more than 24 hours, compared to 20% of mothers in the expectant cohort. Hannah et al.,[2] revealed that the median PROM delivery timeframe was 17.2 percent in the induced cohort and 33.3 percent in the expectant cohort. In the induced cohort 72.4 percent of mothers had spontaneous vaginal delivery, particularly in comparison to 82.8 percent in the expectant cohort. The caesarean rate were 20 % and 12.4 % respectively in the group that was induced as compared to the expectant management group, which was statistically insignificant (P value: 0.13). Though it is statistically insignificant but 8 % difference in caesarean section rate is clinically significant. Author like Kolluri S [14] has shown that the caesarean section rate was 15 % in the induction group as compared to 11.7 % in the expectant group. In a study by Shanti et al.,[17] the caesarean section rate was 12 % in induction group as compared to 5.7 % in expectant group. Our study results the similar result with the author like Kolluri S [14] and Shanti et al.,[17] which shows that the caesarean section rate is more in induction group. In contrast, a study by daGraca Krupa et al.,[15] observed that the proportion of cesarean delivery was 20 percent and 30.7 percent, respectively, in the cohort receiving misoprostol (induced cohort) versus the expectant management cohort Although statistically insignificant (P=0.22), the difference has clinical relevance.

In our investigation, the incident rate of PPH was 12.38 percent in the induction cohort and 7.6 percent in the expectant cohort. PPH was observed to appear in 10% of mothers in the induced patients in comparison to 6.7 percent in the expectant category by Kolluri [14], and in 12 percent of mothers in the induction category contrasted to 10% in the expectant category by Nath [16]. Our study results which infers that incidence of PPH is more in induction group, is similar to the results found by other authors like Kolluri S [14] and Jayati Nath [16]. Chorioamnionitis was observed to be 2.85 percent in the induction cohort and 9.52 percent in the expectant cohort in this investigation. This finding agrees with the results found by the authors like Aqua Ayaz et al [18] and Gibbs et al.,[6] Aqua Ayaz et al.,[18] found no chorioamnionitis cases in induction group whereas it was 12 % in the expectant group. Same value was also found in the study done by Gibbs et al.,[6]. The incidence of neonatal sepsis in induction group was 4.76 % as compared to 20 % in the expectant group in our study. This is corroborative with the result found by the author like Kolluri S [14]. In her study she found no cases of neonatal sepsis but it was 11.7 % in the expectant group. In our study 7.61 % of neonate had Apgar score <7 at one minute as compared to 32.38 % in the expectant group. The result obtained by Kolluri [14] strongly supports these conclusions. It was 15% in the induction cohort against 20% in the expectant cohort, according to her findings. Researchers such as Nath [16] also noticed a related pattern in her research. She observed that in the induction cohort, 16 percent of newborns had an Apgar score of less than 7, opposed to 28 percent in the expectant management cohort in her work, the induction cohort had a 12 percent Apgar score of less than 5 and the expectant cohort had a 20 percent Apgar score of 5 and less. On contrary to our study Ayaz et al.,[18] found no significant difference between the two groups as per birth asphyxia is concerned.

In our study 7.61 % of newborn from the induction group mother got admitted in the neonatal intensive care unit (NICU) as compared to 26.6% from the expectant group. The value was exactly the same for both the groups (1.5%) in a study done by Vaishanav et al.,[19], Chaudhuri S et al.,[20] found in their study that 2.7 % of neonate from the group of mother who had been induced, got admitted in NICU as compared to 3.5% of neonate from the mother who underwent expectant management. Author like Janhavi Mukherya et al.,[21] had a different view regarding these observations. They found in their study that15 % on neonate born from the induction group of women got admitted in the NICU as compared to 11 % from the expectant group of mother. Like every study has its limitation, has also some limitation. Our study was not randomized and not blinded. It was only prospective observational study. It is necessary to create a definition and standardization of endpoints for the evaluations of maternal and neonatal infections.

Conclusion

The study yielded that active management (Induction Group) as per the study methodology for premature rupture of membranes (PROM) had significantly better neonatal outcomes and reduced maternal infectious risks compared to expectant management, despite a slightly higher incidence of postpartum haemorrhage (PPH) and a statistically insignificant increase in caesarean section rates. It is also safer management strategy for term PROM because it drastically reduces the risk of neonatal sepsis, low Apgar scores, NICU admissions, without a statistically significant increase in caesarean rates. However a randomised control trial (RCT) will can yield a finding with better external validity.

Declarations

Acknowledgements

Author acknowledges the guidance of Dr RP Ganguly and Dr A Rakshit for successful completion of the study from its starting point and Dr P Debnath for his guidance in statistical analysis.

Conflict of interest

Nil

Funding/ financial support

Nil

Contributors

Dr Bibekananda Biswas designed the study, Data collection, analysis, manuscript checking, assisted in manuscript preparation. Dr. Debkalyan Maji contributed in writing the initial manuscript, in statistical analysis and drafting of manuscript.

Ethical Clearance

Yes

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