CoffeeNCT03798275
Coffee Consumption and Pregnancy
A study testing coffee in people with Coffee and Pregnancy, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 20 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women with a singleton, uncomplicated pregnancy between the 34th and 37th weeks of gestation were included in this study during routine antenatal examinations
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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)
- Being tested
- coffee
- Keywords
- amniotic fluid index, caffeine, coffee, oligohydramnios
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coffeeDietary supplement
2 g Nescafe Clasico contains approximately 65 mg caffeine
| Study group | Role | What they receive |
|---|---|---|
| the study group | Active comparator | healthy pregnant women with borderline oligohydramnios who accept to drink a cup of coffee Receives: Dietary Supplement: coffee |
| the control group | No intervention | healthy pregnant women with normal amniotic volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
amniotic fluid index
Measured: two hours
fetal renal artery doppler indices
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Jan 2018
- Primary completion1 Aug 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoffeeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf MADENDAG, Kayseri Education and Research Hospital
- Investigators
- YUSUF MADENDAĞ, Principal investigator, Sağlık Bilimleri Üniversitesi Kayseri Şehir hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798275
- Sponsor's protocol ID
- 2017/489
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coffee Consumption on Fetal Renal Artery Blood Flow and Amniotic Fluid Volume in the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT03798275
- Acronym / sponsor ID
- 2017/489
- Keywords
- amniotic fluid index, caffeine, coffee, oligohydramnios
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the study group | Active comparator | Dietary Supplement: coffeehealthy pregnant women with borderline oligohydramnios who accept to drink a cup of coffee |
| the control group | No intervention | –healthy pregnant women with normal amniotic volume |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women with a singleton, uncomplicated pregnancy between the 34th and 37th weeks of gestation were included in this study during routine antenatal examinations
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coffee2 g Nescafe Clasico contains approximately 65 mg caffeine | Dietary supplement | the study group |
Primary outcome
amniotic fluid index
Time frame: two hours
fetal renal artery doppler indices
Time frame: two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YUSUF MADENDAĞ principal investigator
Sağlık Bilimleri Üniversitesi Kayseri Şehir hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coffee in people with Coffee and Pregnancy, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amniotic fluid index (time frame: two hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.