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Can Fasting Ramadan in the Third Trimester in Pregnancy Affects the Fetal Growth.

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ClinicalTrials.gov Identifier: NCT03246711
Recruitment Status : Completed
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
AYMAN ABDELKADER MOHAMED ABDELKADER, Ain Shams Maternity Hospital

Study Description
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Brief 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).

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

.


Condition or disease Intervention/treatment
Fasting Fetal Growth Retardation, Antenatal (Disorder) Behavioral: Fasting

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 159 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: The Effect of 3rd Trimester Ramdan Fasting on Obestetric Outcome
Actual Study Start Date : June 18, 2015
Actual Primary Completion Date : July 17, 2015
Actual Study Completion Date : July 1, 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
Totally fasting
Fasting each day from sunrise to sunset the whole month
 Behavioral: Fasting
Totally or partially fasting the holy month of ramadan for muslims
Partially fasting
means fasting from sunrise to sunset part of the month
 Behavioral: Fasting
Totally or partially fasting the holy month of ramadan for muslims
Non fasting
women who did not fast at all


Outcome Measures
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Primary Outcome Measures :
  1. 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,


Secondary Outcome Measures :
  1. neonatal weight [ Time Frame: at the time of delivery of each participant ]
    measured in grams after delivery

  2. mode of delivery [ Time Frame: at the time of delivery of each participant ]
    percentages of emergency CS due to presumed fetal compromise


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • History of systemic disorder.
  • Smoking narcotics or alcohol use.
  • Have previous history of fetal loss.
  • Multiple pregnancies.
Contacts and Locations
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No Contacts or Locations Provided
  Study Documents (Full-Text)

Documents provided by AYMAN ABDELKADER MOHAMED ABDELKADER, Ain Shams Maternity Hospital:
Study Protocol  [PDF] January 1, 2015
Statistical Analysis Plan  [PDF] October 1, 2015

More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: AYMAN ABDELKADER MOHAMED ABDELKADER, doctor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03246711    
Other Study ID Numbers: AAMABDELKADER 2
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: no confidential data will be shared
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: december 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes