UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040840
Receipt number R000046522
Scientific Title Effects of heavy tea consumption on pregnancy weight gain and neonatal birth weight
Date of disclosure of the study information 2020/06/20
Last modified on 2022/06/22 09:59:53

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Basic information

Public title

Heavy tea intake during pregnancy

Acronym

HTIDP

Scientific Title

Effects of heavy tea consumption on pregnancy weight gain and neonatal birth weight

Scientific Title:Acronym

EHTCPWGNBW

Region

Asia(except Japan)


Condition

Condition

Pregnancy

Classification by specialty

Obstetrics and Gynecology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effects of ingestion of large amounts of black tea (more than 1500 cc/ day) during pregnancy on maternal weight gain and neonatal birth weight.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Pregnancy maternal weight gain

Key secondary outcomes

Neonatal birth weight


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Food

Interventions/Control_1

Usual amounts of tea intake more less 450 cc daily

Interventions/Control_2

mixed beverage, tea and others

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

40 years-old >=

Gender

Female

Key inclusion criteria

singleton pregnancy,
normal pre-gestational body mass index

Key exclusion criteria

chronic illnesses at the first visit and throughout pregnancy such as diabetes mellitus, hypertension, thyroid disease and asthma

Target sample size

1138


Research contact person

Name of lead principal investigator

1st name Shaymaa
Middle name Kadhim
Last name Jasim

Organization

University of Baghdad

Division name

College of Medicine

Zip code

00964

Address

Bab Al-Moaddam, Baghdad, Iraq.

TEL

009647811284170

Email

shaimaa79kadhim@gmail.com


Public contact

Name of contact person

1st name Hayder
Middle name
Last name Al-Momen

Organization

University of Baghdad

Division name

Al-Kindy College of Medicine

Zip code

00964

Address

Al-Nahda square, Baghdad, Iraq

TEL

009647811284169

Homepage URL


Email

hayder77almusawi@gmail.com


Sponsor or person

Institute

University of Baghdad

Institute

Department

Personal name



Funding Source

Organization

University of Baghdad

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

University of Baghdad

Address

Bab Al-Moaddam, Baghdad

Tel

097719807372

Email

sciencevital@yahoo.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



Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 20 Day


Related information

URL releasing protocol

https://scholar.google.com/citations?view_op=view_citation&hl=en&user=2Imnn1sAAAAJ&authuser=1&citati

Publication of results

Published


Result

URL related to results and publications

https://scholar.google.com/citations?view_op=view_citation&hl=en&user=2Imnn1sAAAAJ&authuser=1&citati

Number of participants that the trial has enrolled

135

Results

1500 ml

Results date posted

2022 Year 06 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Throughout one year, a total of 7,063 pregnant ladies coming for first antenatal visit were screened in a major tertiary center. Of them, 1,138 were involved and divided according to their preference into 3 groups: excessive tea (ET), usual tea (UT), and mixed beverages group. The study included women who gave birth to healthy neonates.

Participant flow

Throughout one year, a total of 7,063 pregnant ladies coming for first antenatal visit were screened in a major tertiary center. Of them, 1,138 were involved and divided according to their preference into 3 groups: excessive tea (ET), usual tea (UT), and mixed beverages group. The study included women who gave birth to healthy neonates.

Adverse events

Throughout one year, a total of 7,063 pregnant ladies coming for first antenatal visit were screened in a major tertiary center. Of them, 1,138 were involved and divided according to their preference into 3 groups: excessive tea (ET), usual tea (UT), and mixed beverages group. The study included women who gave birth to healthy neonates.

Outcome measures

1500 ml

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 09 Day

Date of IRB

2018 Year 07 Month 08 Day

Anticipated trial start date

2019 Year 01 Month 02 Day

Last follow-up date

2020 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2021 Year 06 Month 20 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 06 Month 20 Day

Last modified on

2022 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046522


Research Plan
Registered date File name
2022/06/22 6B635F36-969B-4E84-8EB3-A9D3C32F8FD0.jpeg

Research case data specifications
Registered date File name
2022/06/22 00486F78-150F-4EB7-BD1A-B5A7915A91A4.jpeg

Research case data
Registered date File name
2022/06/22 9DDF2451-1ACE-483E-85E9-95529EF134A0.jpeg