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SUMMARY

This is a Prospective observational study to be


conducted in Associated Hospital Government Medical
College in the department of obstetrics and gynaecology.
We aim to study the Perenatal outcome in women neetu
oligohydramnios.

Patients diagnosed with oligohydramnios will be


recreated in the study. Routine Investigations will be
done for them. Patients will be delivered as per hospital
protocol. The Perinatal outcome in women with
oligohydramnios will be noted and analyzed.
Title:

Perinatal outcome in term pregnancies having oligohydramnios


Introduction: -
Oligohydramnios is defined as amniotic fluid index (AFI) below the 5th percentile for

gestational age irrespective of the cause of such a reduction. The causes of oligohydramnios

can be divided into fetal factors (such as congenital anomalies and intrauterine growth

restriction (IUGR) amongst others) to maternal conditions (such as hypertensive disorders and

dehydration) and iatrogenic factors like the use of medications such as non-steroidal anti-

inflammatory drugs. . Crucially, the duration and severity of oligohydramnios play important

roles in deciding perinatal outcomes.1

The pathophysiology of oligohydramnios is multifactorial and involves reduced urine output

from the fetus, which is a primary contributor to amniotic fluid volume in the second half of

pregnancy. This reduction can be a result of renal anomalies or a consequence of compromised

placental blood flow, leading to fetal hypoxia and reduced renal perfusion. Reduced levels of

amniotic fluid results in increased uterine pressure which can compromise umbilical blood

flow. Compromised placenta-fetal circulation may exacerbate fetal distress. IN addition to this

limited movement space for the fetus heightens the risk of musculoskeletal abnormalities and

potentiates the compression of the umbilical cord further endangering fetal well-being. These

pathophysiological insights are important for clinicians in formulating effective management

strategies and in counselling expectant mothers about potential risks and outcomes.2

Chronic oligohydramnios, especially in the second trimester, is often associated with a higher

incidence of pulmonary hypoplasia, skeletal deformations, and fetal growth restrictions,

leading to a spectrum of complications in immediate post-natal period. In addition to above

complications oligohydramnios is also associated with increased incidence of need for cesarean

delivery due to non-reassuring fetal heart rate patterns. The reduction in amniotic fluid volume

compromises the protective space around the fetus, potentially leading to umbilical cord

compression, which can result in intermittent hypoxia and, consequently, fetal distress. This
correlation underscores the need for early detection and monitoring to mitigate adverse

perinatal outcomes in cases with oligohydramnios.

Early and appropriate interventions are essential in managing oligohydramnios to improve

perinatal outcomes. Amnioinfusion (infusion of saline into the amniotic cavity) has been

explored as a therapeutic option (particularly during labor) to reduce the risk of cord

compression and to facilitate fetal monitoring. Maintainance of maternal hydration has shown

good result in increasing amniotic fluid volume, although its impact on improving perinatal

outcomes is still a subject of ongoing research. 3

In cases where oligohydramnios is associated with fetal anomalies or placental insufficiency,

management focuses on optimizing fetal growth and timely delivery. The decision-making

process is heavily reliant on continuous monitoring of fetal well-being Doppler studies,

enabling interventions such as early delivery in cases where the risks of continued pregnancy

outweigh the potential benefits.4

Perinatal outcomes in cases of oligohydramnios represents a critical area particularly

regarding the long-term neonatal outcomes and the effectiveness of various monitoring and

intervention strategies.

We undertook this prospective observational study to analyse the perinatal outcome of

patients with oligohydramnios.


REVIEW OF LITERATURE
Anna Locatelli et al. conducted a retrospective cohort study to to evaluate the effect of

oligohydramnios on perinatal outcome in uncomplicated pregnancies between 40.0 and 41.6

weeks. In this study all uncomplicated pregnancies reaching 40.0 weeks' gestation with a

singleton non-malformed fetus and reliable dating underwent monitoring with serial

determination of amniotic fluid index (AFI) and biophysical profile. Labor was induced for AFI

≤5 cm or other specified conditions. The study included 3,049 women, with 341 (11%) having

AFI ≤5 cm. It was observed that gestational age at delivery, rates of nulliparity and induction

of labor differed significantly between cases with oligohydramnios and those with normal AFI.

A higher incidence of caesarean delivery for non-reassuring fetal heart rate and low birth

weight (<10th percentile) was noted in the oligohydramnios group. However, there were no

significant differences in meconium-stained amniotic fluid, birth asphyxia or umbilical artery

pH between the groups. Logistic regression analysis revealed that oligohydramnios was

independently associated with a higher risk of low-birth-weight centile. On the basis of these

findings, the authors concluded that in uncomplicated pregnancies between 40.0 and 41.6

weeks, oligohydramnios is independently associated with a higher risk of low birth weight

centile.6

Cristina Rossi et al. conducted a systematic review and meta-analysis to evaluate perinatal

outcomes in term and post-term pregnancies with isolated oligohydramnios (IO). In this study

perinatal outcome of patients with oligohydramnios was compared to those with normal

amniotic fluid. For this purpose the authors undertook a thorough search in PubMed, Medline,

EMBASE, and other references, strictly adhering to MOOSE guidelines. In this study

singleton pregnancies with oligohydramnios were included. The meta-analysis, incorporating

data from four studies, provided insights into various perinatal outcomes such as obstetric

interventions, meconium-stained amniotic fluid, low APGAR scores, and small for gestational
age infants. The authors concluded that while isolated oligohydramnios in term or post-term

pregnancies is associated with an increased risk of obstetric interventions other outcomes were

comparable to pregnancies with normal amniotic fluid.7

Nir Melamed et al. conducted a retrospective cohort study to evaluate the perinatal outcomes

in singleton pregnancies complicated by isolated oligohydramnios diagnosed before 37 weeks

of gestation. The research compared outcomes in pregnancies with isolated oligohydramnios

to those in a matched control group with normal amniotic fluid levels. The findings indicated

a higher rate of preterm deliveries and neonatal morbidity in the oligohydramnios group which

were largely attributed to iatrogenic factors. The authors concluded that the adverse outcomes

associated with isolated oligohydramnios diagnosed at less than 37 weeks were significantly

related to iatrogenic prematurity. On the basis of these findings the authors concluded that there

is a need for careful consideration of management strategies in pregnancies affected by

oligohydramnios to mitigate the risk of unnecessary preterm deliveries.8

Hsieh TT et al conducted a study to investigate the perinatal outcomes of patients with

oligohydramnios (amniotic fluid index ≤ 5 cm) without premature rupture of membranes and

fetal congenital anomalies. This research analyzed data from 245 singleton pregnancies,

comparing these oligohydramnios cases to those with normal amniotic fluid volumes. The

study identified significantly higher incidences of various risk factors associated with

oligohydramnios including primiparity and pregnancy-induced hypertension . The results

highlighted that pregnancies with markedly diminished amniotic fluid volume were

significantly associated with adverse perinatal outcomes such as preterm delivery and low birth

weight. On the basis of these findings the authors concluded that oligohydramnios without

associated conditions is significantly linked to adverse perinatal outcomes. This study

emphasized the need for careful monitoring and management of pregnancies with

oligohydramnios.9
N Rabie et al conducted a review study to evaluate adverse pregnancy outcomes associated

with oligohydramnios in singleton pregnancies. The author divided the cases into high-risk

(with comorbid conditions) and low-risk (isolated oligohydramnios) groups and analyzed

outcomes from 15 trials involving over 33,000 women. The findings indicated significantly

higher risks of adverse outcomes such as meconium aspiration syndrome, Caesarean delivery

for fetal distress and need for NICU admissions in cases of isolated oligohydramnios compared

to patients with adequate liquor. Conversely, oligohydramnios in pregnancies with comorbid

conditions showed a significant association with low birth weight but not with other outcomes.

The study underscored the impact of oligohydramnios on pregnancy outcomes, The authors

concluded that while isolated oligohydramnios is linked to specific adverse outcomes, the

presence of comorbid conditions rather than oligohydramnios per se should guide management

decisions in high-risk pregnancies.10


Research Question:
How does oligohydramnios affect perinatal outcomes, including neonatal morbidity and

mortality rates.

Primary Aim:
To investigate the impact of oligohydramnios on perinatal outcomes, focusing specifically on

the rates of neonatal morbidity and mortality.

Primary Objective:
To quantify and compare the rates of neonatal morbidity and mortality in pregnancies with

oligohydramnios versus those with normal amniotic fluid levels.

Secondary Objectives:
To assess the association between the severity of oligohydramnios and the incidence of

specific neonatal morbidities, such as respiratory distress syndrome and birth asphyxia.
Materials And Methods
Source Of Data:
Data obtained from full term pregnancies with a single, non-malformed fetus having

oligohydramnios using amniotic fluid index (AFI).

Study Design:
Hospital-based cross-sectional study.

Study Population:
Full term pregnancies with oligohydramnios.

Study Period:
24 months (January 2024-January 2026).

Study Centre:
Department of OBGY, Medical College, .

" Sample Size Calculation:


The sample size was calculated by the formula N = (Z α2) X σ2 / d2 on the basis of pilot studies

done on the topic of Perinatal outcome in pregnancy complicated with oligohydramnios

(Kumar A et al11) assuming 90% power and 95% confidence interval and based on the central

limit theorem, sample size was determined to be enough if it was 100 thus , we will include at

least 100 cases in our study."

THE FORMULA

N = (Z α2) X SD2/ Precision2

σ =Z α– Statistical constant (1.96)

SD – Expected Standard Deviation (that can be obtained from previous studies or a pilot study).

d – Precision/ allowable error (corresponding to effect size)


STEP 1- Calculate standard error of mean

Standard Error of Mean = Standard Deviation /√ of sample size in pilot study

= 0.2 / √100

= 0.2 / 10

Standard Error of Mean = 0.02

STEP 2: - Calculate precision.

Precision= Z α X Standard Error of Mean

= 1.96 (constant) X 0.02

= 1.96 X 0.02

Precision = 0.0392

Step 3: Calculate sample size.

Sample Size (n) = (Z α2) X σ2 / d2

= 1.962 X 0.22/ 0.03922

= 3.84 X 0.04 / 0.001537

Minimum Required Sample size (N) = 99.8 (rounded off to 100)

Therefore, we will include at least 100 cases in our study. The required number of patients will

comprise of 2 groups.

Group O :– 50 patients with oligohydramnios and completed 37 weeks of gestation will be

included in this group (cases group).


Group A :- 50 patients with adequate liquor and completed 37 weeks of gestation will be

included in this group (Control group).

METHODOLOGY:

A detailed history will be taken from all the patients regarding their last menstrual period

(LMP) date, and the gestational age by LMP will be noted. A history of co-morbid systemic

illnesses such as diabetes mellitus, hypertension, or bronchial asthma will be inquired about

and recorded. An antenatal ultrasound will be performed using a XXXX XXXXXX USG

machine and convex probe.

At the time of labor nature of amniotic fluid will be noted and will be classified as clear, thin

meconium-stained liquor, and thick meconium-stained liquor. Those who developed any signs

of ominous fetal heart rate (FHR) patterns, thick meconium-stained liquor and unfavourable

cervix will be delivered by lower segment caesarean section (LSCS) or forceps delivery. All

newborns will be attended by a Pediatrician who will perform appropriate resuscitative

measures if required. Perinatal outcome will be compared in both the groups in terms of type

of delivery, indications for LSCS, presence of meconium-stained liquor, incidence of Birth

asphyxia (as assessed by APGAR score at 1 min and 5 min), need for NICU admissions and
incidence of stillbirths. All these parameters will be compared in both the groups. Any maternal

complications will also be compared.

STATISTICAL ANALYSIS:

"Statistical analysis will be done using SPSS version 21.0 software. Quantitative data will be presented

as mean and standard deviation. Qualitative data will be presented with incidence and percentage tables.

For quantitative data, unpaired t-test will be applied and for qualitative data, Chi-square test will be

used. p value less than 0.05 will be taken as statistically significant."

Ethical Considerations

The Institutional Ethics Committee clearance will be taken before beginning of the study and

informed and written consent will be obtained from all the participants of the study. There would

be no risk to patient from the study. Maintenance of the confidentiality of records will be strictly

followed. No research related injury is expected to occur. Participants will be free to withdraw from

the study at any point of time without the loss of benefits that he would otherwise be entitled for

the medical treatment. Possible current and future use of the data generated from this study would

be shared with others only for academic and research purpose.


Implications of the study

There are various important clinical implications of this study

1. Clinical Practice Improvement: Understanding the relationship between

oligohydramnios and adverse perinatal outcomes can lead to improved prenatal care.

2. Risk Stratification: By quantifying the impact of oligohydramnios severity on neonatal

outcomes, healthcare providers can better stratify risk for pregnant women and

neonates.

3. Patient Counseling and Decision Making: With a clearer understanding of the potential

risks associated with oligohydramnios, healthcare providers can offer more informed

counseling to expectant parents.

REFERENCES:

1. Keilman C, Shanks AL. Oligohydramnios. [Updated 2022 Sep 12]. In: StatPearls

[Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from:

https://www.ncbi.nlm.nih.gov/books/NBK562326/

2. Ekin A, Gezer C, Taner CE, Ozeren M. Perinatal outcomes in pregnancies with

oligohydramnios after preterm premature rupture of membranes. J Matern Fetal

Neonatal Med. 2015 Nov;28(16):1918-22. doi: 10.3109/14767058.2014.972927. Epub

2014 Oct 28. PMID: 25283853.

3. Hofmeyr GJ, Gulmezoglu AM, Nikodem VC, de Jager M. Amnioinfusion. Eur J Obstet

Gynecol Reprod Biol. 1996;64(2):159-165. doi:10.1016/0301-2115(95)02330-5

4. Wolff F, Schaefer R. Oligohydramnion--Perinatale Komplikationen und Erkrankungen

bei Mutter und Kind [Oligohydramnios--perinatal complications and diseases in mother


and child]. Geburtshilfe Frauenheilkd. 1994;54(3):139-143. doi:10.1055/s-2007-

1023569

5. Leytes S, Kovo M, Weiner E, Ganer Herman H. Isolated oligohydramnios in previous

pregnancy is a risk factor for a placental related disorder in subsequent delivery. BMC

Pregnancy Childbirth. 2022;22(1):912. Published 2022 Dec 6. doi:10.1186/s12884-

022-05230-9

6. Locatelli A, Vergani P, Toso L, Verderio M, Pezzullo JC, Ghidini A. Perinatal outcome

associated with oligohydramnios in uncomplicated term pregnancies. Arch Gynecol

Obstet. 2004;269(2):130-133. doi:10.1007/s00404-003-0525-6.

7. Rossi AC, Prefumo F. Perinatal outcomes of isolated oligohydramnios at term and post-

term pregnancy: a systematic review of literature with meta-analysis. Eur J Obstet

Gynecol Reprod Biol. 2013 Jul;169(2):149-54. doi: 10.1016/j.ejogrb.2013.03.011.

8. Melamed N, Pardo J, Milstein R, Chen R, Hod M, Yogev Y. Perinatal outcome in

pregnancies complicated by isolated oligohydramnios diagnosed before 37 weeks of

gestation. Am J Obstet Gynecol. 2011 Sep;205(3):241.e1-6. doi:

10.1016/j.ajog.2011.06.013. Epub 2011 Jun 15. PMID: 22071052.

9. Hsieh TT, Hung TH, Chen KC, Hsieh CC, Lo LM, Chiu TH. Perinatal outcome of

oligohydramnios without associated premature rupture of membranes and fetal

anomalies. Gynecol Obstet Invest. 1998;45(4):232-6. doi: 10.1159/000009974. PMID:

9623787.

10. Rabie N, Magann E, Steelman S, Ounpraseuth S. Oligohydramnios in complicated and

uncomplicated pregnancy: a systematic review and meta-analysis. Ultrasound Obstet

Gynecol. 2017 Apr;49(4):442-449. doi: 10.1002/uog.15929. PMID: 27062200.

11. KumarA, RaoPS, KumarS, MitraB.Perinatal outcome in pregnancy complicated

witholigohydramnios at term.Int J Reprod Contracept Obstet Gynecol2018;7:3936-40.


AIM AND OBECTIVES

AIM: To study perinertal outcome in oligohydramnios.

OBJECTIVES:

1. To study the maternal outcome in oligohydramnios .

2. To study the fetal outcome in oligohydramnios.


MATERIAL AND METHODS
An observational to study will be conducted in the
department of obstetrics and gynaecology in Associated
Hospital GMC Kathua from March 2024 to September
2025 (18 months duration) after approval from the
hospital ethical committee. All Patients coming to out
patient department of obstetric department of the
hospital and labour room and diagonsed with
oligohydramnios will be taken as study population.
Patients will be questioned about their chief complaints,
menstrual history, obstetric history, socio demographic
history, family history, past history, personal history.
Maternal assessment will be done including general
physical examination , systemic examination including
per abdomen and per vaginal examination .
A through general physical examination will be done
with due clubbing due concern to pallor cyanosis,
edema ,icterus,pedal edema .
Many tools will be required like Blood collection vial
,syringes, BP. Apparatus with cuff , stethoscope.
Maternal outcome will be measured in terms of
gestational age at delivery, outset of labour (spontaneous
or induced ), mode of delivery (vaginal or cessarion
section ). Intrapartum complication like Meconium
staining of Amniotic fluid, Preterm labour, preterm
premature rupture of membrane, Accidental hemorrhage,
Complication like PPH, perpeural sepsis, DIC. Fetal
outcome will be measured in terms of IUQR,
IUD,Iatrogenic Preterm, Spontaneous Preterm,
Meconium stained liquor, Respiratory distress
syndrome, Apgar score at 1 month, 5 month, Birth
weight, NICU adnuisian.

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