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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03246711
Other study ID # AAMABDELKADER 2
Secondary ID
Status Completed
Phase N/A
First received July 22, 2017
Last updated August 9, 2017
Start date June 18, 2015
Est. completion date July 1, 2016

Study information

Verified date August 2017
Source Ain Shams Maternity Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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).

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date July 1, 2016
Est. primary completion date July 17, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Fasting
Totally or partially fasting the holy month of ramadan for muslims

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams Maternity Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Fetal growth assessment of the fetal growth biometry ( estimated fetal weight) every two weeks, through study completion ( from 28 weeks pregnancy till delivery)
Secondary neonatal weight measured in grams after delivery at the time of delivery of each participant
Secondary mode of delivery percentages of emergency CS due to presumed fetal compromise at the time of delivery of each participant
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