UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049005 |
|---|---|
| Receipt number | 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 23:40:07 |
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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
| Obstetrics 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
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
krishraghav2010@gmail.com
Sponsor or person
Institute
Self
Institute
Department
Personal name
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
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
Value
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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/55553
