NCT03798275

Brief Summary

Coffee, tea, and cocoa contain caffeine, a plant alkaloid. They are frequently consumed during pregnancy. We examined the effect of coffee consumption on fetal renal artery blood flow and amniotic fluid index (AFI) in the third trimester of pregnancy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

January 7, 2019

Last Update Submit

January 7, 2019

Conditions

CoffeePregnancy

Keywords

amniotic fluid indexcaffeinecoffeeoligohydramnios

Outcome Measures

Primary Outcomes (2)

  • amniotic fluid index

    two hours

  • fetal renal artery doppler indices

    two hours

Study Arms (2)

the study group

ACTIVE COMPARATOR

healthy pregnant women with borderline oligohydramnios who accept to drink a cup of coffee

Dietary Supplement: coffee

the control group

NO INTERVENTION

healthy pregnant women with normal amniotic volume

Interventions

coffeeDIETARY_SUPPLEMENT

2 g Nescafe Clasico contains approximately 65 mg caffeine

the study group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with a singleton, uncomplicated pregnancy between the 34th and 37th weeks of gestation were included in this study during routine antenatal examinations

You may not qualify if:

  • abnormal amniotic fluid volume (AFV), any intake of nutrient or fluid within the 4 hours previous to ultrasonographic examination \[10\], abnormal Doppler blood flow, hypertension, preeclampsia, chromosomal anomaly, intrauterine growth restriction, fetal anomaly, collagen vascular disease, ruptured fetal membranes, and multiple pregnancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yusuf Madendağ

Kayseri, 38090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Oligohydramnios

Interventions

Coffee

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • YUSUF MADENDAĞ

    Sağlık Bilimleri Üniversitesi Kayseri Şehir hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
obstetrics and gynecology

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

January 1, 2018

Primary Completion

August 1, 2018

Study Completion

November 20, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

TU(1)