FastingNCT03246711
Can Fasting Ramadan in the Third Trimester in Pregnancy Affects the Fetal Growth.
An observational study of Fasting and Fetal Growth Retardation, Antenatal (Disorder), run by Ain Shams Maternity Hospital.
Trial summary
Prospective comparative cohort study including 159 pregnant women at the third trimester recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during the holy month of Ramadan (from 18th June To 16th July 2015). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting, Fetal Growth Retardation, Antenatal (Disorder)
- What is being tested?
- Fasting
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- 18 Jun 2015to 1 Jul 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Prospective comparative cohort study including 159 pregnant women at the third trimester recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during the holy month of Ramadan (from 18th June To 16th July 2015). The patients recorded their pattern of fasting during Ramadan then grouped into three groups A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally fasting group
Who may be able to join
- Age from 20 - 35 years.
- Third trimester pregnancy (starting from 28 weeks) which is going to be calculated according to the date of the last menstrual period \& confirmed by ultrasonography.
- Normal healthy women with average body mass index (BMI). Normal range (18.5 to 25).
- Women included have no medical disorder.
Who cannot join
- History of systemic disorder.
- Smoking narcotics or alcohol use.
- Have previous history of fetal loss.
- Multiple pregnancies.
About this study
Official title: The Effect of 3rd Trimester Ramdan Fasting on Obestetric Outcome
Prospective comparative cohort study including 159 pregnant women at the third trimester recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during the holy month of Ramadan (from 18th June To 16th July 2015).
The patients recorded their pattern of fasting during Ramadan then grouped into three groups A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally fasting group
.
Read the detailed description
Many pregnant muslims women fast during Ramadan Since fasting during Ramadan is one of the five pillars of Islam and is a central part of Muslim culture, many women may fear a loss of connection with their communities or would feel guilty if they did not observe Ramadan. Each year, about 400 million out of 1 billion Muslims do this duty. Such tasks like eating, drinking, and smoking are forbidden from sunrise until sunset. Fasting during pregnancy has been always considered as a debatable condition.
Many women ask their obstetricians if fasting is safe for their baby or not? There have been many studies on metabolic changes and different aspects of human health during and after Ramadan .but there have been few studies on the effect of fasting on pregnancy outcome and there are also some controversies in the findings of different studies.
All mothers within the age range of 20 - 35 years and in the 3rd trimester pregnancy (starting from 28 weeks) which is going to be calculated according to the date of the last menstrual period \& confirmed ultrasonically, normal healthy women with average body mass index (BMI) and Women included have no medical disorder.
Women who fulfilled the eligibility criteria were subjected an ultrasound fetal biometry every 2 weeks till delivery and assess fetal weight after delivery.
- Being tested
- Fasting
- Medical subject headings
- Fasting, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingBehavioural
Totally or partially fasting the holy month of ramadan for muslims
| Study group | Role | What they receive |
|---|---|---|
| Totally fasting | Fasting each day from sunrise to sunset the whole month Receives: Behavioral: Fasting | |
| Partially fasting | means fasting from sunrise to sunset part of the month Receives: Behavioral: Fasting | |
| Non fasting | women who did not fast at all |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal growth
assessment of the fetal growth biometry ( estimated fetal weight) every two weeks,
Measured: through study completion ( from 28 weeks pregnancy till delivery)
Secondary outcomes (2)
neonatal weight
measured in grams after delivery
Measured: at the time of delivery of each participant
mode of delivery
percentages of emergency CS due to presumed fetal compromise
Measured: at the time of delivery of each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start18 Jun 2015
- Primary completion17 Jul 2015
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYMAN ABDELKADER MOHAMED ABDELKADER, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246711
- Sponsor's protocol ID
- AAMABDELKADER 2
- Status last verified
- Aug 2017
- First submitted
- 22 Jul 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: no confidential data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 3rd Trimester Ramdan Fasting on Obestetric Outcome
- ClinicalTrials.gov ID
- NCT03246711
- Acronym / sponsor ID
- AAMABDELKADER 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 18 Jun 2015 (actual)
- Primary completion
- 17 Jul 2015 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 11 Aug 2017 (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.
Prospective comparative cohort study including 159 pregnant women at the third trimester recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during the holy month of Ramadan (from 18th June To 16th July 2015).
The patients recorded their pattern of fasting during Ramadan then grouped into three groups A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally fasting group
.
Detailed description
Many pregnant muslims women fast during Ramadan Since fasting during Ramadan is one of the five pillars of Islam and is a central part of Muslim culture, many women may fear a loss of connection with their communities or would feel guilty if they did not observe Ramadan. Each year, about 400 million out of 1 billion Muslims do this duty. Such tasks like eating, drinking, and smoking are forbidden from sunrise until sunset. Fasting during pregnancy has been always considered as a debatable condition.
Many women ask their obstetricians if fasting is safe for their baby or not? There have been many studies on metabolic changes and different aspects of human health during and after Ramadan .but there have been few studies on the effect of fasting on pregnancy outcome and there are also some controversies in the findings of different studies.
All mothers within the age range of 20 - 35 years and in the 3rd trimester pregnancy (starting from 28 weeks) which is going to be calculated according to the date of the last menstrual period \& confirmed ultrasonically, normal healthy women with average body mass index (BMI) and Women included have no medical disorder.
Women who fulfilled the eligibility criteria were subjected an ultrasound fetal biometry every 2 weeks till delivery and assess fetal weight after delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Totally fasting | – | Behavioral: FastingFasting each day from sunrise to sunset the whole month |
| Partially fasting | – | Behavioral: Fastingmeans fasting from sunrise to sunset part of the month |
| Non fasting | – | –women who did not fast at all |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Prospective comparative cohort study including 159 pregnant women at the third trimester recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during the holy month of Ramadan (from 18th June To 16th July 2015). The patients recorded their pattern of fasting during Ramadan then grouped into three groups A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally fasting group
Key inclusion criteria (4 listed)
- Age from 20 - 35 years.
- Third trimester pregnancy (starting from 28 weeks) which is going to be calculated according to the date of the last menstrual period \& confirmed by ultrasonography.
- Normal healthy women with average body mass index (BMI). Normal range (18.5 to 25).
- Women included have no medical disorder.
Key exclusion criteria (4 listed)
- History of systemic disorder.
- Smoking narcotics or alcohol use.
- Have previous history of fetal loss.
- 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 |
|---|---|---|
| FastingTotally or partially fasting the holy month of ramadan for muslims | Behavioural | Partially fasting, Totally fasting |
Primary outcome
Fetal growth
Time frame: through study completion ( from 28 weeks pregnancy till delivery)
assessment of the fetal growth biometry ( estimated fetal weight) every two weeks,
2 secondary outcomes
neonatal weight
Time frame: at the time of delivery of each participant
mode of delivery
Time frame: at the time of delivery of each participant
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 11 Aug 2017.
- Individual participant dataSharing planned: Yes. no confidential data will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting and Fetal Growth Retardation, Antenatal (Disorder), run by Ain Shams Maternity Hospital.
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 4 inclusion and 4 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Fetal growth (time frame: through study completion ( from 28 weeks pregnancy till delivery)). 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 11 Aug 2017.