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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000049005
Receipt No. R000055553
Scientific Title A study to evaluate the effectiveness of selected antenatal interventions on maternal and neonatal outcome in terms of prevention of preterm delivery among high - risk pregnant women attending antenatal clinics of selected hospitals of Dadra and Nagar Haveli
Date of disclosure of the study information 2022/09/22
Last modified on 2022/09/22

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Basic information
Public title IMPACT OF ANTENATAL INTERVENTIONS ON MATERNAL AND NEONATAL OUTCOMES
Acronym MATERNAL AND NEONATAL OUTCOMES
Scientific Title A study to evaluate the effectiveness of selected antenatal interventions on maternal and neonatal outcome in terms of prevention of preterm delivery among high - risk pregnant women attending antenatal clinics of selected hospitals of Dadra and Nagar Haveli
Scientific Title:Acronym MATERNAL AND NEONATAL OUTCOMES
Region
Asia(except Japan)

Condition
Condition High Risk pregnant women diagnosed anemia, teenage pregnancy and previous history of abortion or still birth
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assess the effectiveness of selected antenatal interventions on maternal outcome between control and experimental group of high - risk pregnant women


Basic objectives2 Others
Basic objectives -Others compare the maternal outcome between control and experimental group of high - risk pregnant women


Assess the effectiveness of selected antenatal interventions on neonatal outcome between control and experimental group of high - risk pregnant women

Compare the neonatal outcome between control and experimental group of high - risk pregnant women
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Maternal and Neonatal Outcomes
Key secondary outcomes Association between maternal and neonatal outcomes with selected Socio-Demographic variables

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 7
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 Video assisted teaching on Antenatal care, Antenatal advices, care of high risk pregnancy, Postnatal care and newborn care for 30 minutes of duration
Interventions/Control_2 Demonstration on antenatal exercises & breast feeding techniques for 30 minutes of duration
Interventions/Control_3 Information booklet on Antenatal care, Antenatal advices, care of high risk pregnancy, Postnatal care and newborn care at the first antenatal visit
Interventions/Control_4 Minimum eight antenatal contacts (12th, 20th, 26th, 30th, 34th, 36th, 38th and 40 weeks of gestation) as per WHO guidelines
Interventions/Control_5 Measurement of cervical length at 20 weeks of gestation
Interventions/Control_6 Daily monitoring and compliance to antenatal interventions by pregnant women from 12 weeks of gestation till delivery
Interventions/Control_7 Telephonic monitoring and counseling on compliance to antenatal interventions from 12 weeks of gestation till delivery
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
13 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria High risk pregnant women with Teenage pregnancy, anemia and previous history of still birth and abortion
Key exclusion criteria other high risk pregnant women
Target sample size 362

Research contact person
Name of lead principal investigator
1st name VADIVUKKARASI
Middle name
Last name P
Organization SHRI VINOBA BHAVE COLLEGE OF NURSING, SILVASSA
Division name OBSTETRICS AND GYNAECOLOGICAL NURSING
Zip code 396230
Address SHRI VINOBA BHAVE CIVIL HOSPITAL, SILVASSA
TEL 917046593297
Email krishraghav2010@gmail.com

Public contact
Name of contact person
1st name VADIVUKKARASI
Middle name
Last name P
Organization SHRI VINOBA BHAVE COLLEGE OF NURSING, SILVASSA
Division name OBSTETRICS ANF GYNAECOLOGICAL NURSING
Zip code 396230
Address SHRI VINOBA BHAVE CIVIL HOSPITAL, SILVASSA
TEL 917046593297
Homepage URL
Email krishraghav2010@gmail.com

Sponsor
Institute Self
Institute
Department

Funding Source
Organization Self
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NAMO Medical education and Research Institute and Shri Vinoba Bhave Civil Hospital, Silvassa
Address Shri Vinoba Bhave Civil Hospital Campus, Silvassa
Tel 8690693020
Email gargisvbch.sil@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Shri Vinoba Bhave Civil Hospital, Silvassa

Other administrative information
Date of disclosure of the study information
2022 Year 09 Month 22 Day

Related information
URL releasing protocol Acta Scientific | International Open Library | Open Access Journals Publishing Group
Publication of results Partially published

Result
URL related to results and publications Acta Scientific | International Open Library | Open Access Journals Publishing Group
Number of participants that the trial has enrolled 322
Results Selected antenatal interventions had high impact on maternal and neonatal outcomes in terms of prevention of preterm delivery
Results date posted
2022 Year 09 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 06 Month 21 Day
Baseline Characteristics the risk factors such as Maternal anemia (97(30%)), Teenage pregnancy (93(29%)), both Teenage pregnancy & Maternal Anemia (61(19%)), Previous history of abortion (49(15%)) and previous history of still birth (22(7%)).
Participant flow Files attached
Adverse events Nil
Outcome measures The effectiveness of antenatal interventions on maternal weight gain. Calculated mean of weight gain in the control group was 9.56 + 1.85 whereas in experimental group it was 11.4 + 1.15. Maternal blood Haemoglobin showed that in the control group it was 10.42 + 2.94 whereas in experimental group it was 11.42 + 3.06. Calculated mean of gestational age in the control group was 32.36+1.16 whereas; in experimental group it was 39.46+2.34.
Plan to share IPD Yes
IPD sharing Plan description Files attached

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
2019 Year 10 Month 12 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
2021 Year 05 Month 31 Day
Date trial data considered complete
2021 Year 05 Month 31 Day
Date analysis concluded
2021 Year 06 Month 15 Day

Other
Other related information Files attached

Management information
Registered date
2022 Year 09 Month 22 Day
Last modified on
2022 Year 09 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055553

Research Plan
Registered date File name
2022/09/22 Research methodology PHD.docx

Research case data specifications
Registered date File name
2022/09/22 DATA COLLECTION PROCEDURE PHD.docx

Research case data
Registered date File name
2022/09/22 Coding sheet after final presenattion 13th July, 2021.xlsx


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