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

NCT03246711 | Completed

• 1 other identifier: AAMABDELKADER 2
• Study Type: observational
• Target: 159
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Fasting; Fetal Growth Retardation, Antenatal (Disorder)

Outcome Measures

Primary Outcomes (1)

• Fetal growth

  assessment of the fetal growth biometry ( estimated fetal weight) every two weeks,

  through study completion ( from 28 weeks pregnancy till delivery)

Secondary Outcomes (2)

• neonatal weight

  at the time of delivery of each participant

• mode of delivery

  at the time of delivery of each participant

Study Arms (3)

Totally fasting

Fasting each day from sunrise to sunset the whole month

Behavioral: Fasting

Partially fasting

means fasting from sunrise to sunset part of the month

Behavioral: Fasting

Non fasting

women who did not fast at all

Interventions

Fasting BEHAVIORAL

Totally or partially fasting the holy month of ramadan for muslims

Partially fasting; Totally fasting

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• History of systemic disorder.
• Smoking narcotics or alcohol use.
• Have previous history of fetal loss.
• Multiple pregnancies.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

MeSH Terms

Conditions

Fasting; Fetal Growth Retardation

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 22, 2017
• First Posted: August 11, 2017
• Study Start: June 18, 2015
• Primary Completion: July 17, 2015
• Study Completion: July 1, 2016
• Last Updated: August 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: december 2019