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

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

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Study Overview

• Status: Completed
• Conditions: Fasting; Fetal Growth Retardation, Antenatal (Disorder)
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 159

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal growth	assessment of the fetal growth biometry ( estimated fetal weight) every two weeks,	through study completion ( from 28 weeks pregnancy till delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal weight	measured in grams after delivery	at the time of delivery of each participant
mode of delivery	percentages of emergency CS due to presumed fetal compromise	at the time of delivery of each participant

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2015
• Primary Completion (ACTUAL): July 17, 2015
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: July 22, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (ACTUAL): August 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: AAMABDELKADER 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: no confidential data will be shared
• IPD Sharing Time Frame: december 2019
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No