INTRODUCTION

Reproduction has been the central idea in the concept of continuity of species. For
mammals including human being, pregnancy and childbirth are the indispensable functions that
enabled its continuous survival for millennia. In India, women of childbearing age consist of
19% of the population7. Maternal health and age play a crucial role during pregnancy and
childbirth. Pregnancy being a delicate and a long-term condition, the mother and foetus are
vulnerable to various risks. One of the risk factors for such complication is elderly pregnancy,
which leads to many complications during pregnancy, labour and also for the baby1.

Historically, advanced maternal age has been defined as women who are 35 years or
older at estimated date of delivery according to ACOG. Also, Laopaiboon et al on behalf of the
WHO Multicountry Survey on Maternal Newborn Health Research Network defined Advanced
maternal age as pregnancy in women aged 35 years or older14.

A study done in 29 countries (Africa, Asia, Middle East, and Latin America) revealed
that the magnitude of pregnant women with advanced maternal age was 12.3%14.

A good number of women shows tendency to postpone their pregnancy well late beyond
the third decade of their life, even into the fourth and fifth decades in certain cases.

The reason for delayed pregnancy could be classified into those in urban regions and
those in rural areas. Changes in the structure of family with more late marriages or remarriages,
women’s chase of higher education, career advancement, and advances in assisted reproductive
technique along with availability of effective and safe contraceptives are urban reasons, while
the cultural reasons and illiteracy being the main causes in rural areas8,9.

Pregnancy after the age of 35 years can be challenging due to the maternal and fetal
risk involved. Chronic hypertension, diabetes mellitus, miscarriage, subfertility, ectopic
pregnancy, antepartum haemorrhage, anaemia, malpresentation, postpartum haemorrhage all
lead to augmented incidence of instrumental deliveries as well as caesarean sections10. The
uterine vascular system has less ability in adapting to increased hemodynamic demand during
pregnancy17.

Fetal along with neonatal risk is also augmented because of raised incidence of
chromosomal abnormalities (mainly Down's syndrome), IUGR, multiple pregnancy,
prematurity leading to greater number of NICU admission. Perinatal morbidity as well as
mortality is raised in these pregnant women10. Therefore, scientific evidences and publications

1
indicates adverse maternal and fetal outcomes in case of advanced maternal age. Western and
advanced countries have contributed much to the study of this topic while in case of India it is
still nascent. Since, the trend of advanced maternal age is expected to be upward, it necessitates
studies focussing on this topic and updating of knowledge.

Furthermore, the result of this study can be utilized by concerned bodies to optimize
natal care given in case of elderly gravidae.

Hence, this study was conducted to evaluate the maternal and perinatal outcomes of
pregnancies in advanced maternal age.

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 REVIEW OF LITERATURE

Deshpande et al1 conducted a hospital-based, prospective, observational study in the

department of Obstetrics and Gynaecology at Government Medical College and Hospital,
Aurangabad, Maharashtra in 2022 and came to the conclusion that women with advanced
maternal age are at great risk of antepartum, intrapartum, and postpartum complications and
should be provided close supervision for better pregnancy outcome. The fetal outcomes can be
jeopardized by higher rates of low birth weight, lower APGAR score at 5 minutes and other
complications like sepsis, pneumonia, and asphyxia in neonates of mother with advanced
maternal age. Such neonatal complications may necessitate NICU admissions for some babies.
However, with adequate care and timely referrals to tertiary care centres, the maternal and
perinatal outcomes can be promising despite more chances of complications.

Mehari et al2 conducted a cross-sectional study in Ayder comprehensive specialized

hospital, North Ethiopia, from 2015 to 2017 which revealed that advanced maternal age
pregnancy was significantly associated with pregnancy induced hypertension [AOR 4.15, 95%
CI (2.272–7.575), p < 0.001], antepartum haemorrhage [AOR 2.54, 95% CI (1.32–4.91), P =
0.005] & caesarean delivery [AOR 2.722, 95% CI (1.777–4.170), p < 0.001]. Furthermore,
advanced maternal age pregnancy was also increasingly associated with adverse perinatal
outcomes like preterm delivery [AOR 3.622, 95% CI (1.469–8.930), p = 0.005], low birth
weight [AOR 3.137, 95% CI (1.324–7.433), p = 0.009], perinatal death [AOR 2.54, 95% CI
(1.141–5.635), p = 0.022] and low fifth minute APGAR score [AOR 7.507, 95% CI (3.134–
17.98), p < 0.001]. Notwithstanding this, maternal age was not found to be associated with
amniotic fluid disturbances, premature rupture of membranes and post-term pregnancy.

Kenny et al3 conducted a population-based cohort study using data on all singleton
births in 2004–2008 from the North Western Perinatal Survey based at The University of
Manchester, UK and compared pregnancy outcomes in women aged 30–34, 35–39 and >40
years with women aged 20–29 years. Women aged 40+ at delivery were at increased risk of
stillbirth (RR = 1.83, [95% CI 1.37–2.43]), pre-term (RR = 1.25, [95% CI 1.14–1.36]) and very
pre-term birth (RR = 1.29, [95% CI 1.08–1.55]), Macrosomia (RR = 1.31, [95% CI 1.12–1.54]),
extremely large for gestational age (RR = 1.40, [95% CI 1.25–1.58]) and Caesarean delivery
(RR = 1.83, [95% CI 1.77–1.90]).

Montori et al4 included a total of 27,455 singleton and consecutive pregnancies

attending at the Hospital Clinico Lozano Blesa in Zaragoza from 2007 to 2018 in a cohort

3
study. The mean age of the women was 31.21 years. No differences were found associated with
age for neonatal acidosis, an Apgar score< 7 at 5 min after birth, threatened preterm labour,
preterm rupture of membranes, or high-grade perineal tear. The analyses found statistically
significant increases in the rates of hypertensive disorders, diabetes mellitus, induction of
labour, and caesarean section, after 35 years of age. The risks of fetal death, neonatal admission,
small for gestational age, placenta previa, instrument delivery, maternal ICU admission, and
postpartum haemorrhage were greater after 40 years of age.The results of the study indicated
that women >35 years of age had worse perinatal out-comes, compared with younger women.
This finding was more evident in patients >40 years of age, which highlighted the greater risk
of fetal death and serious maternal complications in this group.

Traisrisilp et al5 conducted a retrospective cohort study at Maternal Fetal Medicine unit,
Chiang Mai University Thailand in 2015 which showed 797 women at age of 40 years or more
had significantly higher rates of medical diseases, such as chronic hypertension or
pregestational diabetes mellitus. Caesarean rate, preterm delivery, and fetal growth restriction.

Mahato et al6 conducted a cross sectional analytical study at department of Obstetrics

and Gynaecology, Manipal Teaching Hospital, Pokhara, Nepal in 2021. A total of 198 patient
who were ≥30 years and >24 weeks pregnant admitted in obstetric ward were selected. These
patients were divided into three groups according to their age (30-34, 35-39 and ≥ 40years and
the incidence of adverse maternal and perinatal outcome among these groups were compared.
Comparison of the three age groups revealed that advanced maternal age constitutes a
predisposing factor for malpresentation, gestational diabetes mellitus, placenta previa, fetal
distress and caesarean section. Whereas, risk of non-progress of labour, preterm birth,
postpartum haemorrhage, perinatal death and congenital anomalies were increased in very
advanced maternal age group. From these, statistical significance was reached in case of greater
risk of malpresentation (p=0.01, OR=6.66), fetal distress (p=0.04, OR=2.6) and caesarean
section (p=0.02, OR=2.06) in advanced age group when compared to the patients aged 30-34.
Furthermore, very advanced age group were higher risk of postpartum haemorrhage (p=0.03,
OR=2.47) and congenital anomalies, which were statistically significant (p=0.04, OR=29.57)
when compared to the 30-34 years.

Anozie et al11 conducted a five-year retrospective study in 2019 among elderly

primigravidae. The study assessed 78 booked primigravidae aged 35 years or more who
delivered at the Federal Teaching Hospital Abakaliki. During the study period, the mean age

4
of the elderly primigravidae was 36.28±1.20 years. The study group had more antepartum
complications with anaemia, antepartum haemorrhage, hypertensive disorders of pregnancies,
diabetes mellitus and preterm labour (p<0.05). Intrapartum complications such as poor
progress of labour and cephalo-pelvic disproportion were also significantly higher. Almost half
of the study group were delivered by caesarean section, the commonest indication being
maternal request based on prolonged infertility (16.67%). The study group had higher
incidence of preterm delivery and perinatal mortality of significant proportion. However, they
were more likely to come for the 6th week postnatal visit 71.2% versus 32.1%.

Thatal et al12 conducted a cross sectional study on elderly primigravidae

in Regional Institute of Medical Sciences, Imphal, Manipur over a period of one
and half year. Elderly primigravida admitted at term in hospital
were studied for fetomaternal outcome. Maternal complications seen were, Oligohydramnios
6.02%, Gestational hypertension 3.01%, Breech presentation 6.03%, PROM 4.2%, Placenta
Praevia 2.4%, Gestational diabetes mellitus 0.6% and Twin gestation 2.4%. Caesarean rate was
67.5% of which 62.5% was done for cephalopelvic disproportion. 5.3% baby was low birth
weight.

Lean et al13 conducted a systematic review and meta-analysis in accordance with the
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines
and Meta-Analysis of Observational Studies in Epidemiology Group (MOOSE) criteria in
2017. Literature searches were conducted in MEDLINE (Ovid), EMBASE, ClinicalTrials.gov
and LILACS and the Cochrane Database of Systematic Reviews using the search terms
“maternal age”, “advanced”, “pregnancy” and “outcome” combined. Out of 1940 identified
titles; 63 cohort studies and 12 case-control studies were included in the meta-analysis. The
analysis showed Advanced Maternal Age(AMA) increased the risk of stillbirth (OR 1.75,
95%CI 1.62 to 1.89) with a population attributable risk of 4.7%. Similar trends were seen for
risks of FGR, neonatal death, NICU unit admission restriction and GDM. The relationship
between AMA and stillbirth was not related to maternal morbidity or Assisted Reproductive
Technique(ART).

Laopaiboon et al14 conducted a Secondary analysis of the facility-based, cross-sectional

data of the WHO Multicountry Survey on Maternal and Newborn Health. The prevalence of
pregnant women with AMA was 12.3%. Advanced maternal age significantly increased the
risk of maternal adverse outcomes, including maternal near miss (MNM), maternal death

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(MD), and severe maternal outcome (SMO), as well as the risk of stillbirths and perinatal
mortalities.

Claramonte Nieto et al15 conducted a retrospective cohort of euploid singleton

pregnancies delivered from January 2007 to June 2017. A total of 25054 pregnancies were
included. Mean maternal age was 34.7 ± 4.2 years, with 2807 patients in the group of age
between 40 and 44 years (11.2%) and 280 patients ≥45 years (1.1%). Women at AMA had
higher incidence of previous comorbidities (compared to the reference group of women
< 30 years): prior c-section, chronic hypertension and obesity. In addition, they were more
likely to use ART. After adjusting for confounding factors, maternal age was an independent
and statistically significant risk factor for gestational diabetes (OR 1.66/2.80/3.14) for ages 30–
39, 40–44 and ≥ 45 years respectively, C-Section (OR 1.28/2.41/7.27) and placenta previa (OR
2.56/4.83) for ages 40–44 and ≥ 45 years respectively, but not for preeclampsia (neither early-
onset nor late-onset). Risk of emergency c-section was only increased in women ≥45 years (OR
2.03 [95% CI, 1.50–2.74]). In the other groups of age, the increase in C-Section rate was
because of elective indications. Age ≥ 45 years was associated with iatrogenic prematurity
< 37 weeks (OR 2.62, [95% CI 1.30–5.27]). No other relevant associations between AMA and
maternal or neonatal outcomes were found.

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 AIMS AND OBJECTIVES

• To study the maternal outcome in advanced maternal age at pregnancy.

• To study the fetal outcome in advanced maternal age at pregnancy.

• To determine factors associated with favourable and unfavourable maternal outcome in

pregnancy with advanced maternal age.

• To determine factors associated with favourable and unfavourable fetal outcome in

pregnancy with advanced maternal age.

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 MATERIALS AND METHODS

Study design: Prospective observational study.

Study setting: The study will be conducted in the Department of Obstetrics and Gynaecology,
Jawaharlal Nehru Institute of Medical Sciences, Porompat, Imphal East, Manipur on all women
attending the antenatal clinics, irrespective of the residence of the attending women.

Study Duration: April 2023 till March 2025

Study Population: All pregnant women aged ≥ 35years attending the Antenatal Clinic visit
in OBGYN OPD during the period of study will be enrolled.

Inclusion Criteria:

• Pregnant mothers whose age is ≥ 35 years were regarded as a study group.

• Cases willing to undergo required investigations and participate in the study.
• Any gravida or parity.
• All consecutive OPD attendees are considered till the necessary sample size is achieved.
• Mother and child are followed up till a period of 24 hours post delivery.

Exclusion Criteria:

• Patient refusal to participate in the study.

• Lost to follow up.

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 SAMPLE SIZE

The sample size will be calculated using the formula given below-

𝑍𝛼2 𝑃𝑄
𝑛=
𝑒2

Where,

Z = value of normal deviation at 95 % confidence lead =1.96

P = prevalence = 17.6 % =.176 where P is prevalence of pregnant women >35yrs in a

previous study setting2.

Q = 1 – P = .824

e= Absolute allowable error =5%

(1.96)2 × .176 × .824

𝑛=
(.05)2

0.5571241984
= 0.0025

=222.84

=223 + 20% (adjustment for missing data)

=267.6

=268

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 OPERATIONAL DEFINITIONS

Advanced maternal Age: Any pregnant women aged ≥ 35yrs at the time of delivery.

Unfavourable maternal outcomes include: pregnancy induced hypertension, anaemia,

prolonged pregnancy, antepartum hemorrhage, placenta previa, placenta accreta
spectrum, abruptio placentae, gestational diabetes mellitus, need for cesarean delivery
either elective or emergency, maternal ICU admission.

Unfavourable fetal outcomes include: intrauterine growth restriction, polyhydramnios,

oligohydramnios, preterm delivery and very preterm delivery, Small for gestational age,
large for gestational age, macrosomia, low fifth minute apgar score, neonatal admissions,
stillbirth and neonatal death.

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Data Collection Procedure:

Data of the patient will be recorded in predesigned manner enclosed in the annexure in
the patients of Department of Obstetrics and Gynaecology, JNIMS. The particulars, history,
investigation, examination, treatment, follow up details will be recorded at the time of
admission.

Following procedure will be followed while conducting the study:

1. The researcher herself will be responsible for data collection.

2. After approval from the Ethics Committee, JNIMS, Imphal, informed consent from the
participating patients will be taken.
3. Prospective Observational study will be conducted on consecutive 268 ANC women
attending the outpatient department and followed up till 24 hours after termination of
pregnancy.
4. Risk factors associated with pregnancy in enrolled pregnant women are anemia,
previous LSCS, Gestational DM, hypothyroidism, gestational HTN, severe
preeclampsia, UTI, COVID-19, eclampsia, multiple gestation, fibroid.
5. Detailed clinical, obstetrical, medical and surgical history will be taken.
6. General and systemic examination with reference to CVS, CNS, RS, P/A and P/V will
be done.
7. At the end, the maternal outcome will be noted.
8. The confidentiality of the interview will be maintained by assigning enrolment number
for each case and use for data analysis.

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Statistical Analysis:

Data collected will be analysed using SPSS version 21(statistical package for social
science) will be presented in a descriptive manner. Chi-square test and other suitable analytical
test will be used and keeping p value <.05 to be a significant value.

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 ETHICAL ISSUES

Approval of the ethics committee of the institute will be sought and informed written consent
will be obtained from the participant patient and confidentiality will be maintained.

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 SUMMARY

Advanced Maternal Age in pregnancy is very common in the present time which
has led to adverse feto maternal outcomes. A hospital based prospective observational
study will be done in women with advanced maternal age to assess if any maternal and
fetal adverse outcome leads from it in Department of Obstetrics and Gynaecology,
Jawaharlal Nehru Institute of Medical Sciences (JNIMS), Imphal by taking history and
observation of the outcome of pregnancy from the enrolled women after obtaining
approval from ethics committee and following hospital protocols. The data required for
the study will be collected according to the proforma (Annexure-I) and will be analysed
and interpreted by appropriate statistical methods.

14
 REFERENCES

1. Deshpande SS, Gadappa S, Badgire S, Dandale SU. Maternal and perinatal outcome in
Advanced Maternal Age (>=35 years). A prospective observational study at an Indian
Tertiary care centre Eur J Mol Clin Med. 2022;9(3)2622-30.
2. Mehari M, Maeruf H,Robles CC,Woldemariam S, Adhena T, Mulugeta M,Haftu A,
Hagose H, Kumsa H. Advanced maternal age pregnancy and its adverse obstetrical and
perinatal outcomes in Ayder comprehensive specialized hospital, Northern Ethiopia,
2017: a comparative cross-sectional study. BMC Pregnancy and Childbirth. 2020 Jan;
20(60).
3. Kenny LC, Lavender T, McNamee R, O’Neill SM, Mills T, Khashan AS. Advanced
Maternal Age and Adverse Pregnancy Outcome: Evidence from a Large Contemporary
Cohort. [PLoS ONE 2013 Feb 20; 8(2): e56583].
4. Montori MG, Martinez AA, Alvarez CL, Cuchi NA, Alcala PM, Martinez SR.
Advanced Maternal Age and adverse pregnancy outcomes: A Cohort Study. Taiwan J
Obstet Gynecol. 2021 Jan;60(1):119-24.
5. Traisrisilp K, Tongsong T. Pregnancy Outcomes of Mothers with Very Advanced
Maternal Age (40 Years or More). J Med Assoc Thai 2015;98(2):117-22.
6. Mahato V, Shrestha P, Bhattarai P. Advanced Maternal Age and Pregnancy Outcome
at Manipal Teaching Hospital: Cross-sectional Analytical study. Nepal Journal of
Medical Sciences. 2021;6(1):20-25.
7. Gulani KK. Community health nursing, Principles and Practices. Kumar Publishing
House New Delhi;2005:351.
8. Bianco A, Stone J, Lynch L, Lapinski R, Berkwiutz G, Berkowitz RL. Pregnancy
outcomes at age 40 and older. Obstet Gynecol. 1996;87(6):917-22
9. Unnithan M, Susan B, William L, Dimitrios N. Reproductive Ageing. Chloe V, Ruth
CF. Pregnancy and advanced maternal age. Progress in Obstetrics and gynecology.
Cambridge University Press;2009:22-26.
10. Rajput N, Paldiya D, Verma YS. Effects of advanced maternal age on pregnancy
outcome. Int J Reprod Contracept Obstet Gynecol 2018;7:3941-5.
11. Anozie OB, Mamah JE, Esike CU, Asiegbu OG, Lawani LO, Eze JN, Onoh RC.
Pregnancy Outcome among Elderly Primigravidae: A Five-year Review at Abakaliki,
Ebonyi State, Nigeria. J Clin of Diagn Res.2019;13(1):QC01-QC04.

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12. Thatal, Luksom and Narwat. Fetomaternal outcome in elderly primigravida. Indian
Journal of Obstetrics and Gynaecology Research 2020;7(2):243–47.
13. Lean SC, Derricott H, Jones RL, Heazell AEP (2017) Advanced maternal age and
adverse pregnancy outcomes: A systematic review and meta-analysis. PLoS ONE
12(10): e0186287.
14. Laopaiboon M, Lumbiganon P, Intarut N, Mori R, Ganchimeg T, Vogel JP, Souza
JP, Gulmezoglu AM, on behalf of the WHO Multicountry Survey on Maternal
Newborn Health Research Network. Advanced maternal age and pregnancy outcomes:
a multicountry assessment. BJOG 2014;121 (suppl. 1):49-56.
15. Nieto MC, Barrabes EM, Martínez SG. Impact of aging on obstetric outcomes:
defining advanced maternal age in Barcelona. BMC Pregnancy Childbirth. 2019 Sep
23;19,342.
16. De Weger FJ, Hukkelhoven CW, Serroyen J, te Velde ER, Smits LJ. Advanced
maternal age, short interpregnancy interval, and perinatal outcome. Am J Obstet
Gynecol 2011;204:421-9.

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 PROFORMA
ANNEXURE- I
PROFORMA FOR THE THESIS

Case NO MRD NO. Unit:

1.PARTICULARS:
Name:
Age:
Religion:
Husband /father’s Name:
Age of husband:
Address:
Community:
Socio economic status

2. Chief complaint:

3. History of presenting complaints:

4.Menstrual history
Age of menarche:
Duration of menstruation:
Duration of cycles:
Amount of flow:
Clots association
Dysmenorrhoea:
LMP

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5. Past obstetric history:

Sl. Year and date Pregnancy Labour Mode of puerperium Status of

No. event event delivery the baby

No. of living issue:

Male_____/ Female____
Health status of the baby:
Immunisation:
LCB:

6. History of past medical/surgical/gynaecological illness:

7. Personal history:

8. Drug/ allergy /dietary history:

9. Contraception history:

10. ART technique______/ Ovulation Induction_____

11. Family history:

12. Immunisation history of TT:

13. General family history:

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14. General physical examination:
Built:
Nutrition:
Pallor:
Icterus:
Oedema:
Dehydration:
Clubbing:
Lymphadenopathy:
Height:
Weight:
Pulse:
BP:
Temperature:
Respiratory rate:
15. Systemic examination
Respiratory system:
Cardiovascular system:
Central nervous system
Per abdomen:
Fundal height(cm):
Uterine size (in weeks):
Fundal grip:
Pelvic grip:
Presenting part:
On auscultation:
FHS:
Rate:
Rhythm:
Per vaginal examination:
Station:
Cervical dilatation:
Effacement (%)Caput:
Presenting part:

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 Pelvis assessment: adequate/borderline/inadequate
Membranes: present/absent.
16. Clinical diagnosis: Normal/abnormal.
17. Complicated with: Anaemia/Eclampsia/Prematurity/IUGR/Placenta previa/
Accidental haemorrhage/cord prolapse/hydramnios/UTI/
Diabetes/Rh Incompatibility.

18. Laboratory Investigations:

• Complete hemogram
• ABO/Rh grouping
• BT/CT
• PT/INR
• TFT
• RBS
• LFT
• KFT
• R-Ab
• HbsAg
• HCV-Ab
• ECG
• Urine R/E and C/S
• USG FWB
• Doppler study
• Double marker/ Nuchal translucency
• Triple test/ Quadruple test
• Level II Anomaly scan
• NIPT/Amniocentesis/Karyotyping
17. Labour Record
• Mode of delivery
• NVD_____/ Ventouse_____/Forceps____
• LSCS- Elective____/Emergency_____
- Ligation +/-
20. Baby note:

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 Sex: male/female
Weight: kg
Apgar score: 1 minute 5 minute
Date of delivery:
Time of delivery:
Congenital anomaly:
21. Maternal complications:
Duration of hospital stay:
Hysterectomy:
Blood transfusion:
Management:
Maternal mortality: Yes/No
22. Complication to infant
NICU admission +/-
23. Infant follow up:
Perinatal mortality if any:
Cause of perinatal mortality:

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 ANNEXURE-II

INFORMED CONSENT

Part-I

(PARTICIPATION INFORMATION SHEET)

Title: FETOMATERNAL OUTCOME IN ADVANCED MATERNAL AGE: A

CROSS SECTIONAL STUDY
Participant ID :
Principal Investigator : Dr. Khutheibam Sabanam Choudhury
Guide: Dr. Ratana Usham
Associate Professor,
Department of Obstetrics and Gynaecology
JNIMS, Manipur.

INTRODUCTION

My name is Dr. Khutheibam Sabanam Choudhury and I am a post graduate student in the
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Institute of Medical Sciences
(JNIMS), Imphal, Manipur. I am doing a study on “Fetomaternal outcome in advanced
maternal age. You are requested for participation by chance and not any other reason. This
consent form gives the information about the study. You are being requested to think about the
participation in this study through this consent form. It is necessary for you to receive complete
information about this study prior to your participation. Therefore, this information here should
be fully understood and if you are willing to participate you will have to give your signature in
this consent form with the date.

Purpose of the study: A prospective observational study on “ Fetomaternal outcome in

advanced maternal age: A Cross sectional study”.

Procedure of the study: If you agree to participate in this study, you will have to furnish
detailed history of your present pregnancy and examination will be done on you for the same.
I will also request you to undergo some necessary routine investigation and special
investigations of thyroid. At the end of this form, I will request you to give a valid consent for
each of these procedures. You may choose to participate if you are willing to or you may not

22
if you refuse to do so. You may choose not to answer some of the personal questions if you are
not willing to. There is no right or wrong answer to any of the questions. This study doesn’t
promise to give you free treatment but to give you all necessary support from us. Risks and
benefits of participating in this study: You may feel discomfort when detailed history is taken
or samples for investigations are taken. Some may even not like to disclose some of the
questions I ask. It is up to you to evaluate and answer. So, risk and benefit of participation are
completely under your discretion of evaluation. No additional risk is associated with the
participants as it is a purely observational study. Participation to the study is confidential and
will be beneficial to the future management and counselling of the said condition. The decision
to not participate or withdraw at any time from the study can be taken by you.

Confidentiality: I will keep your personal information confidential. In all other form beside
consent form, instead of name, only the code number shall be mentioned. However, collective
data without identifier will be presented and may be published.

Eligibility:

You should be 35 years and above and willing to participate in this study.

Risks and benefits of participating in this study:

You may feel discomfort when detailed history is taken. Some may even not like to disclose
some of the questions I ask. It is up to you to evaluate and answer. So, risk and benefit of
participation are completely under your discretion of evaluation.

Compensation for your participation: There is no cost to you to participate in this study.
You will be checked free of cost but for the necessary investigations and medicines which you
may need shall have to be managed by you.

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Questions regarding the study: If you ever have any questions about this study, you may
contact

Name of the doctor: Dr. Khutheibam Sabanam Choudhury

Department: Department of Obstetrics and Gynaecology

Address: JNIMS, Imphal

Contact No: 9366227323

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 PART II

(CONSENT FORM)

Statement to be read by a person willing to participate in the study.

I have read this consent completely/this consent form has been read out to me. I
understand that I can withdraw my participation anytime, if I feel so. I have received and
understood the information about my rights and have been promised that my personal
information shall be kept confidential. All my doubts have been cleared.

I want to participate in this study on my own free will and I am willing to give my
consent to proceed for the same.

Date:

Place:

Name of the witness: Participant’s name:

Signature/Thumb Impression Signature/Thumb Impression

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