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

NCT ID: NCT03246711

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 159 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-18
• Study Completion Date: 2016-07-01

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

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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.

Conditions

Fasting; Fetal Growth Retardation, Antenatal (Disorder)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Totally fasting

Fasting each day from sunrise to sunset the whole month

Fasting

Intervention Type: BEHAVIORAL

Totally or partially fasting the holy month of ramadan for muslims

Partially fasting

means fasting from sunrise to sunset part of the month

Fasting

Intervention Type: BEHAVIORAL

Totally or partially fasting the holy month of ramadan for muslims

Non fasting

women who did not fast at all

No interventions assigned to this group

Interventions

Fasting

Totally or partially fasting the holy month of ramadan for muslims

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

AYMAN ABDELKADER MOHAMED ABDELKADER

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AAMABDELKADER 2

Identifier Type: -

Identifier Source: org_study_id