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

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 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

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

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