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CTRI Number  CTRI/2024/12/077843 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Preventive 
Study Design  Other 
Public Title of Study   Effectiveness of Nursing Interventions on Maternal and Fetal/ Neonatal Outcomes among Low BMI Antenatal Women. 
Scientific Title of Study   Effectiveness of Nursing Interventions on Maternal and Fetal/ Neonatal Outcomes among Low BMI Antenatal Women 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeetha X 
Designation  PhD student  
Affiliation  Ramaiah institute of nursing education and research 
Address  Associate Professor Room no 006 OBG Nursing Department Ramaiah institute of nursing education and research MSR Nagar MSR IT post Bangalore Karnataka
MSR Nagar MSR IT post Bangalore 560054
Bangalore
KARNATAKA
560054
India 
Phone  9035727540  
Fax  08023604055  
Email  sangeethanicholas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MV Smitha 
Designation  Ph D Guide 
Affiliation  College of nursing All India Institute of Medical Sciences 
Address  Reader Associate professor OBG Nursing Departmnet college of nursing All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar
Sijua Patrapada Bhubaneswar 751019
Khordha
ORISSA
751019
India 
Phone  7411740520  
Fax    
Email  speak2smitha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MV Smitha 
Designation  Ph D Guide 
Affiliation  college of nursing All India Institute of Medical Sciences 
Address  Reader Associate professor college of nursing OBG Nursing Department All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar
Sijua Patrapada Bhubaneswar751019
Khordha
ORISSA
751019
India 
Phone  7411740520  
Fax    
Email  speak2smitha@gmail.com  
 
Source of Monetary or Material Support  
The data collection will be done at Selected BBMP maternity hospitals 1. Ganganagar Maternity Home 3rd Cross, Cbi Road, Ganganagar, Bangalore - 560032 (Behind St Jude Church) 2. Srirampura referral hospital, Srirampuram, Bangalore - 560021 Karnataka INDIA  
 
Primary Sponsor  
Name  Sangeetha X 
Address  Lecturer OBG Nursing Department Ramaiah Institute of Nursing education and research Bangalore 560054 INDIA 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSridevi  Urban Health centers/ Maternity Hospitals  Selected BBMP maternity hospitals Ganganagar Maternity Home 3rd Cross Cbi Road Ganganagar Bangalore 560032 (Behind St Jude Church) Srirampura referral hospital Srirampuram Bangalore 560021
Bangalore
KARNATAKA 
9880108147

sreedevideepakraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ramaiah Medical College Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  pregnant women with BMI 19 and below 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Maternal weight gain Birth weight of the newborn  Antenatal women with BMI 19 or below in the control group who receive routine care  
Intervention  Nursing interventions  Nursing interventions: refers to Nutrition education and cooking demonstration video of multigrain porridge to Antenatal women with BMI of 19 or below.  Nutritional education will be imparted to pregnant women about weight gain during pregnancy, nutritional requirements, different food groups, sources of macro and micro nutrients, importance of nutritional supplementation, and food safety during pregnancy and avoidance of substances during pregnancy, in two sessions at 2 weeks interval.  Cooking demonstration video refers to preparation of porridge by using multigrain powder made from mixture of roasted wheat, soya, jowar, ragi, foxtail millet, brown rice, groundnut, green gram, red gram and jaggery. 75 grams of powder will be mixed with water to prepare porridge. 2 serving of porridge (75gms morning+ 75 gms evening) gives 575 kcal energy with 20 gms of protein. • Participants will be motivated to follow the nursing interventions by SMS / Whatsapp • Reinforcement of Nutrition Education will be given according to the need • Antenatal women who has faulty dietary practices will be counseled and educated intensively  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant mother with
BMI 19 or below
singleton pregnancy
in first trimester
with mobile phones
 
 
ExclusionCriteria 
Details  Pregnant mother with
multiple pregnancy
preexisting conditions – GDM, Pre-eclampsia, Living with HIV
no intention to deliver in the study setting
Groundnuts and soya allergy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Improved in weight to the extent of at least 2 kgs as compared to nonintervention group
2 Improved in weight to the extent of at least 400gms as compared to non-intervention group 
at 26, 30, 34, 38th weeks of pregnancy and at the time of birth 
 
Secondary Outcome  
Outcome  TimePoints 
maternal BMI, midarm circumference and Haemoglobin values
neonatal length, Apgar score, term gestation 
at 26, 30, 34, 38th weeks of pregnancy and at the time of birth 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title of the research project : Effectiveness of Nursing Interventions on Maternal and Fetal / Neonatal Outcomes among Low BMI Antenatal Women

Summary of the proposed study : This proposed research project is “To Evaluate the Effectiveness of Nursing Interventions on Maternal and Fetal/ Neonatal Outcomes among Low BMI Antenatal Women attending Antenatal OPD at Maternity hospitals, Bangalore. Permission will be obtained from the concerned authority. All antenatal women in 1st trimester attending antenatal OPD will be screened for BMI (height, weight and BMI will be calculated) and antenatal women with BMI 19 or below will be identified. Samples will be selected according to selection criteria after obtaining informed consent. Total of 70 subjects will be assigned to experimental and control group (35+35). Pre-test will be conducted at 6-12th week of gestation for both the group. Nursing interventions (Multigrain power and Nutrition education) will be given to experimental group from 13th to 38th week of gestation; control group will receive routine care. Post-test will be conducted at 26, 30, 34, 38th weeks of gestation and at birth for both the groups. Collected data will be entered in the excel sheet. Analysis will be done by using descriptive and inferential statistics.
Justification or Need for the study :

•        Malnutrition in pregnancy:In  developing countries20% to 39%of women are with Low body mass index (<18.5 kg/m2)1.South Asia had the highest proportion of underweight women with an estimated 24%.There were 270 000 deaths (95% UI 249 000–295 000) from nutritional deficiencies in 2017  representing 2·60% (2·37–2·86) of all deaths in that year 2.In India 58.7% of Pregnant women (15-49 years) with anemia, 33.3% Women in reproductive age are undernourished, 42.2% Indian women who are underweight when they begin pregnancy(NFHS4). In Karnataka the prevalence of women with low BMI is 20% .Only 68.7 % of women received the mandatory of three antenatal check-up, Utilization of public health services is 26% only. 3,4

 

•        Effect of Poor nutrition in pregnancy:  Higher risk of preterm delivery, Small for gestational age (SGA), Still birth, Low birth weight (LBW) - important secondary factor in 40%–80% of neonatal deaths,5,6 Risk of maternal mortality, Anemia and Pregnancy-induced hypertension (PIH), Third trimester bleeding and premature rupture of membranes, Prolonged labour,  Postpartum hemorrhage and Puerperal endometritis7

 

•        Nutrition practices in Karnataka: Numerous food items which are nutritious and safe and available locally are either restricted or denied in Karnataka. During pregnancy food items like Ragi, papaya, mango, guava, pineapple, jackfruit, jaggery, sesame seeds, dates, all kinds of meat, eggs, milk and spices are reported to be avoided8,9

 

•        Nutrition management in Karnataka: There are many programmes existing in Karnataka to manage malnutrition in pregnancy such as Supplementary feeding programmes- Mathru Pushtivardhini, Prasoothi Araike, Special nutrition programme, Integrated child development services scheme, Applied nutrition programme, Distribution of iron and folic acid tablets.10Although nutrition policies are on the books and interventions are in place, child malnutrition and maternal under-nutrition persist as severe public health problems. Quality of services should be maintained in existing programs, Knowledge gaps about nutrition and nutrition practice need to be filled11

 

•        UNICEF and FIGO recommends Food/dietary supplements and Nutrition counselling to be offered to pregnant undernourished women.12Healthcare professionals should ensure appropriate gestational weight gain in relation to prepregnancy BMI .13Nutritional health education should be designed after studying the pregnant women’s’ nutritional habits and usual intake .

               Malnutrition is a modifiable risk factor. A healthy maternal dietary pattern during pregnancy reduces the risk of maternal and infant complications.  Low BMI pregnant women need help and nutritional support for appropriate weight gain during pregnancy. Improving the health and nutritional status requires a series of actions to raise the quality and increase the coverage of service. Midwives/Nurses play a vital role in early identification of malnutrition during pregnancy.  Hence the rresearcher is interested to prepare multigrain powder which is affordable and low cost,  to compensate the nutrition need of Low BMI pregnant women.(550 kcal energy and 27 gms of protein) and offer nutrition education. So this project helps in early identification of low BMI pregnant women and offers multigrain power and nutrition education to enhance weight gain during pregnancy and prevent the complications to mother and fetus.

    Objectives:

•        To evaluate the effectiveness of Nursing Interventions on Maternal outcomes and Fetal / Neonatal outcomes among low BMI antenatal women

•        To find the correlation between Maternal weight gain and fetal weight, crown to heel length and Birth weight among low BMI antenatal women

•        To determine the association of Maternal outcomes  and Fetal / Neonatal outcomes with Maternal variables among low BMI antenatal women

 

 Hypotheses :

•        H1- There is a difference in the mean maternal outcomes and Fetal / Neonatal outcomes of antenatal women between the experimental group and the control group

•        H2- There is a correlation between maternal weight gain and Fetal weight, Crown to heel length & Birth weight.

•        H3- There is an association of maternal outcomes and Fetal  / Neonatal outcomes with maternal variables.

Ø  Detailed description of procedure:

Ethical clearance

 

Obtain permission to conduct study

 

Maternity hospitals (BBMP) will be identified

 

                                                                                                            Maternity hospital A (Control group)                          Maternity hospital B (Experimental group)          

 


All antenatal women attending antenatal OPD at selected Maternity hospital will be screened for BMI (height, weight and BMI will be calculated) during 1st trimester

 

Antenatal women with BMI 19 or below will be identified

 

Samples will be selected according to selection criteria after obtaining informed consent.

                                                                                                                            Control group                                                                              Experimental group

                                                                                                                         Pre-test                                                                                                       Pre-test

                                                                                                                                                                                                                                                    

                                                                                                                          Routine care                                                                                    Nursing interventions

                                                                                                                                                                                                                                           

                                                                                                                           Post-test -26,30,34,38 weeks and at birth                           Pos-ttest -26,30,34,38 weeks and at birth

PILOT STUDY WILL BE CONDUCTED WITH 10 SAMPLES {5+5}

Nursing interventions: refers to Nutrition education and cooking demonstration video of multigrain porridge to Antenatal women with BMI of 19 or below.

Ø  Nutritional education will be imparted to pregnant women about weight gain during pregnancy, nutritional requirements, different food groups, sources of macro and micro nutrients, importance of nutritional supplementation, and food safety during pregnancy and avoidance of substances during pregnancy, in two sessions at 2 weeks interval.

Ø  Cooking demonstration video refers to preparation of porridge by using multigrain powder made from mixture of roasted    wheat, soya, jowar, ragi, foxtail millet, brown rice, groundnut, green gram, red gram and jaggery. 75 grams of powder will be mixed with water to prepare porridge. 2 serving of porridge (75gms morning+ 75 gms evening) gives 575 kcal energy with 20 gms of protein.

•      Participants  will be motivated to follow  the nursing interventions by SMS / Whatsapp

•      Reinforcement of Nutrition Education will be given according to the need

•      Antenatal women  who has faulty dietary practices will be counseled and educated intensively

 

 

Tools and techniques

•      Screening tool

•      Questionnaire on maternal variables

•      Questionnaire  on Knowledge regarding diet during pregnancy

•      Questionnaire  on Nutrition practice during pregnancy

•      Information sheet on maternal and fetal /neonatal outcomes

•      Questionnaire  on Antenatal care service utilization

 

Ø  Place of the study:

Antenatal Outpatient departments of BBMP Maternity hospitals such as

§  Srirampura Refferal hospital

§  Ganganagar BBMP maternity home

§  Hosahalli Refferal hospital

§  Kovindaraj nagar BBMP maternity home

Ø  Outcome measures:

Outcomes

Variable

Timeframe

Maternal

Weight gain

26,30,34,38 weeks

Mid upper arm circumference (MUAC)

between 22-26th week and 34-38th week

Haemoglobin

between 22-26th week and 34-38th week

Minor ailments in pregnancy

between 22-26th week and 34-38th week

Complications during pregnancy( anaemia, pre- eclampsia, and gestational diabetes)

between 22-26th week and 34-38th week

 

Mode of delivery

After birth

Complications during labour (if any)

After birth

Knowledge regarding diet during pregnancy

pretest and post-test after 10 days of nutrition education

Nutrition practices

pretest and post-test between 22-26th week and 34-38th week

Fetal / Neonatal

Fetal weight

Crown to heel length

between 22- 26and 34-38 weeks

Birth outcomes

birth weight

At birth

Apgar score

At birth

Gestational age

At birth

length of neonate

At birth

Birth defects

At birth

Preterm birth

At birth

Stillbirth

At birth

 

Ø  Statistical methods:

Descriptive statistics

•       Frequency and percentage distribution will be used to describe sample characteristics , maternal outcomes , Nutrition Practices and Antenatal care services utilization

•      Mean, Mean difference and Standard Deviation will be used to interpret Maternal and Fetal /Neonatal outcomes between the groups

Inferential statistics

•      Independent t test will be performed to compare knowledge score between experimental and control group

•      Repeated measure ANOVA will be used to identify the difference in the score over time between the groups

•      Pearson correlation coefficient will be computed to correlate Maternal weight gain and Fetal weight, Crown to heel length & Birth weight.

•      Chi square test will be used to find the association of Maternal outcomes and Fetal / Neonatal outcomes with maternal variables.

•      Multi -variate analysis will be performed to find the relationship between Nutrition practices and maternal weight gain, birth weight of neonate.

 
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