- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03798275
Coffee Consumption and Pregnancy
January 7, 2019 updated by: Yusuf MADENDAG, Kayseri Education and Research Hospital
The Effect of Coffee Consumption on Fetal Renal Artery Blood Flow and Amniotic Fluid Volume in the Third Trimester of Pregnancy
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
Study Overview
Detailed Description
This cross-sectional study occurred in a tertiary center with volunteer pregnant women who agreed to drink coffee.
In healthy pregnant women with isolated borderline oligohydramnios, AFI and fetal renal artery blood flow indices were evaluated before and after coffee consumption.
Sixty three patients for the borderline oligohydramnios group (the study group) were included in this study.
These patients were compared with 63 healthy pregnant women who had normal amniotic fluid volume (the control group)
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kayseri̇, Turkey, 38090
- Yusuf Madendağ
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant women with a singleton, uncomplicated pregnancy between the 34th and 37th weeks of gestation were included in this study during routine antenatal examinations
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: the study group
healthy pregnant women with borderline oligohydramnios who accept to drink a cup of coffee
|
2 g Nescafe Clasico contains approximately 65 mg caffeine
|
No Intervention: the control group
healthy pregnant women with normal amniotic volume
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
amniotic fluid index
Time Frame: two hours
|
two hours
|
fetal renal artery doppler indices
Time Frame: two hours
|
two hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: YUSUF MADENDAĞ, Sağlık Bilimleri Üniversitesi Kayseri Şehir hastanesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
November 20, 2018
Study Registration Dates
First Submitted
January 7, 2019
First Submitted That Met QC Criteria
January 7, 2019
First Posted (Actual)
January 9, 2019
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2017/489
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
University Hospital, ToursCompleted
-
Technische Universität DresdenWithdrawnPregnancy Trimester, Second | Pregnancy Trimester, First | Pregnancy Trimester, ThirdGermany
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Universitair Ziekenhuis BrusselMerck Serono International SAUnknownPregnancy | Pregnancy LossBelgium
-
Turku University HospitalUniversity of TurkuCompleted
-
Centre Hospitalier René DubosCompletedDeciduitis; Complicating Pregnancy
Clinical Trials on coffee
-
University Hospital HeidelbergUnknown
-
University of California, San FranciscoRecruiting
-
Mondelēz International, Inc.St. Luke's-Roosevelt Hospital CenterCompleted
-
Eastern Mediterranean UniversityCompletedCardiovascular DiseasesCyprus
-
University of British ColumbiaUnknownInflammatory Response | Cognitive Function | Leukocytosis | TriglyceridesCanada
-
Cedars-Sinai Medical CenterCompletedPostoperative IleusUnited States
-
University of ChileSociété des Produits Nestlé (SPN)Completed
-
Assistance Publique - Hôpitaux de ParisRecruitingADCY5-related DyskinesiaFrance
-
West German Center of Diabetes and HealthTchibo GmbHCompleted
-
Massachusetts Eye and Ear InfirmaryCompleted