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

Status

Completed

Conditions

Intervention / Treatment

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

Clinical Trials on coffee

3
Subscribe