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CTRI Number  CTRI/2020/07/026846 [Registered on: 28/07/2020] Trial Registered Prospectively
Last Modified On: 19/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the Effectiveness of Antenatal Mother’s Overview List (ANMOL) Mobile Application in terms of Maternal And Fetal Outcome in Labour room of department of Obstetrics and Gynaecology in Wardha District, Maharashtra –A Randomized Controlled Trial 
Scientific Title of Study   To evaluate the Effectiveness of Antenatal Mother’s Overview List (ANMOL) Mobile Application in terms of Maternal And Fetal Outcome. 
Trial Acronym  ANMOL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Kavita J Gomase  
Designation  Assistant Professor 
Affiliation  Datta Meghe Institute Of Medical Sciences Deemed to be University  
Address  Smt Radhikabai Meghe Memorial College Of Nursing Datta Meghe Institute Of Medical Sciences Deemed to be University
same as address 1
Wardha
MAHARASHTRA
442001
India 
Phone  9175515580  
Fax    
Email  kavitapravin3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Vaishali Taksande  
Designation  Professor & Dean Academic(Nursing Faculty) 
Affiliation  Datta Meghe Institute Of Medical Sciences Deemed to be University  
Address  Smt Radhikabai Meghe Memorial College Of Nursing Datta Meghe Institute Of Medical Sciences Deemed to be University
same as address 1
Wardha
MAHARASHTRA
442001
India 
Phone  9970423710  
Fax    
Email  vtaksande@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ms Kavita J Gomase  
Designation  Assistant Professor 
Affiliation  Datta Meghe Institute Of Medical Sciences Deemed to be University  
Address  Smt Radhikabai Meghe Memorial College Of Nursing Datta Meghe Institute Of Medical Sciences Deemed to be University
same as address 1
Wardha
MAHARASHTRA
442001
India 
Phone  9175515580  
Fax    
Email  kavitapravin3@gmail.com  
 
Source of Monetary or Material Support  
No source of monetary or material support. Study part of Doctoral thesis submitted for Ph.D Nursing in Datta Meghe Institute Of Medical Sciences (Deemed to be University ). 
 
Primary Sponsor  
Name  Ms Kavita J Gomase  
Address  Smt Radhikabai Meghe Memorial College Of Nursing Datta Meghe Institute Of Medical Sciences Deemed to be University  
Type of Sponsor  Other [self sponsored ] 
 
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 
Ms Kavita J Gomase  Acharya Vinoba Bhave Rural Hospital  Department of Obstetrics and Gynecology, Ward no.12
Wardha
MAHARASHTRA 		 9175515580

kavitapravin3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Antenatal mother’s overview list mobile application(ANMOL)  ANMOL mobile application the tools used for assessing the physiological parameters in terms of maternal and fetal outcome. Step 1 - For collecting data in ANMOL mobile application, as the women admitted in labor room with 4 cm cervical dilation and with more than 34 weeks gestation will be enrolled for the using ANMOL mobile application. Step 2 – After enrolling the women for the study, Section A: In ANMOL mobile application, Demographic variable includes followings physiological parameters. Section B : In ANMOL – 1, Patient will be assessed with following physiological parameters at the interval of one hour till the 24 h after delivery  
Comparator Agent  Contemporary protocol   Control group which follows the contemporary protocol for assessing maternal and fetal outcome. For collecting data, as women admitted in labor room with 4 cm cervical dilation and with more than 34 weeks gestation will be enrolled for the study in control group.  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant Women In Labour (>4 Cm Cervical Dilatation) Pregnant Women With More Than 34 Weeks Gestation
 
 
ExclusionCriteria 
Details  Pregnant Women With High Risk Pregnancies (Pregnancy Induced Hypertension, Gestational Diabetes Mellitus, Heart Diseases, Renal Diseases, IUGR
Pregnant Women With Preterm Labor 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Maternal outcome
A. Maternal severe complications during delivery
a. Seizures
b. Loss of consciousness
c. High grade fever with foul smell
d. Hemorrhage
B. Mode of delivery
a. Normal delivery
b. LSCS
c. Assisted delivery ( forceps / ventous)

Fetal outcome
1. APGAR score in 1 min
2. APGAR score in 5 min
3. Weight in gram
4. NICU admission Days in NICU

 		 Baseline data from the time admission in labour room,
Then every hourly till the delivery.
After delivery every three hourly for 48 hours.
After delivery of baby

 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal outcome :
Maternal death
Fetal outcome: Still birth and Early neonatal death
 		 6weeks,

At the time of delivery due to any complication
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/08/2020 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Kavita J Gomase, Prof. Vaishali Taksande , Dr. Arpita Jaiswal , "IS THE ANTENATAL MOTHER OVERVIEW LIST (ANMOL ) MOBILE APPLICATION EFFECTIVE IN TERMS OF MATERNAL AND FETAL OUTCOME?", IJRAR - International Journal of Research and Analytical Reviews (IJRAR), E-ISSN 2348-1269, P- ISSN 2349-5138, Volume.6, Issue 1, Page No pp.398-402, March 2019, Available at : http://www.ijrar.org/IJRAR19J3850.pdf  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This study is a randomized, participant blinde , sealed opaque envelope, observation trail comparing  Antenatal Mother’s Overview List (ANMOL) Mobile Application with   contemporary protocol in terms of Maternal And Fetal Outcome. As the women admitted in labor room of Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha, with >4 cm cervical dilation  and with more than  34 weeks gestation  will be enrolled for the using ANMOL mobile application.

The Primary outcomes of pregnancy studied are:-

·       Maternal severe complications during delivery  (Seizures ,Loss of consciousness ,High grade fever with foul smell, Hemorrhage)

·       Mode of delivery  (Normal delivery ,LSCS,Assisted delivery )

The secondary outcome of pregnancy are

   Maternal death

Primary outcome of neonate after delivery

·     APGAR score in 1 min

  • APGAR score in 5 min 
  • Weight in gram NICU admission Days  in NICU
  Secondary outcome of neonate: Still birth  and Early neonatal death . Primary outcome will be assessed by observational checklist after delivery and at postnatal period. Secondary outcome will be all –cause mortality at 6 weeks. 
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