Role of Ginkgo Biloba Extract in IUGR

Effects of Oral Ginkgo Biloba Extract on Pregnancy Complicated by Asymmetrically Intrauterine Growth Restriction: a Double-blinded Randomized Placebo-controlled Trial

The use of herbal medicinal products is increasing enormously in recent years, mainly among women, who use them for the most varied purposes, such as in menstrual problems, menopausal symptoms, mood disturbances and to strengthen their bones. Most of these benefits are due to the flavonoids present in these products. These flavonoids have anticarcinogenic, antiviral, antioxidant and antiinflammatory activities, as well as being used in the treatment of osteoporosis, menopausal symptoms and cardiovascular diseases . Besides the benefits from the consumption of flavonoids, little is known about their safety and potentially harmful toxic effects, such as mutagenicity and genotoxicity which might occur if taken in large doses . Safety of Ginkgo biloba during pregnancy or lactation was not criticized in literature. Roasted and raw ginkgo seed were not reported in the evidence-based medicine literature as being either safe or contraindicated in pregnancy or lactation. A higher incidence of postpartum hemorrhage was reported in the literature when associated with a 3-month ingestion of Ginkgo Biloba extract. Flavonoids are components of Ginkgo biloba L. (Ginkgoaceae), a medicinal plant widely used by the population . G. biloba has its origin in China, Korea and Japan where its fruits and leaves have been used as food and medicine for a long time.

The extract of G. biloba (EGb) is composed of different terpene trilactones, i.e., ginkgolides A, B, C, J and bilobalide, many flavonol glycosides, biflavones and alkylphenols . The major flavonoids in the extract are kaempferol, quercetin and isorhamnetin] whose metabolites were found in the blood of rats and in human urine after oral administration of EGb. Due to its actions as an anti-inflammatory and antioxidant, EGb has been largely used in the treatment of Alzheimer's disease, pre-menstrual syndrome, cerebrovascular insufficiency and peripheral arterial occlusive disease . In folk medicine, EGb is used as a vermifuge, to induce labor, for the treatment of bronchitis, chronic rhinitis, chilblains, arthritis and edema . The aim of this study was to evaluate the effect of oral supplementation of Ginkgo Biloba extract on the fetal weight as well as feto-maternal blood flow in cases of intrauterine growth restriction.

Study Overview

• Status: Completed
• Conditions: Intrauterine Growth Restriction (IUGR)
• Intervention / Treatment: Other: Placebo; Drug: Ginkgo Biloba Extract

• Study Type: Interventional
• Enrollment (Actual): 226
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women in their third trimester (28-30 weeks of gestation).
• Pregnant women whose pregnancy was complicated with intra uterine growth restriction (IUGR).
• Normal Doppler indices in uterine, umbilical and middle cerebral arteries at time of recruitment.

Exclusion Criteria:

• Multiple pregnancies,
• Hypertension,
• Fetal congenital anomalies,
• Previous history of congenital anomalies or chromosomal abnormalities.
• Diabetes Mellitus
• Premature pre-labor rupture of membranes
• Antepartum hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ginkgo Biloba Extract group; This group received Ginko Biloba, two tablets per day	Drug: Ginkgo Biloba Extract
Placebo Comparator: Placebo group; This group received placebo two tablets per day .	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fetal weight (gm)	one and half year

Secondary Outcome Measures

Outcome Measure	Time Frame
Doppler blood flow changes in uterine arteries indices	one and half year
Doppler blood flow changes in umbilical arteries indices	one and half year
Doppler blood flow changes in middle cerebral artery indices	one and half year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 24, 2015

Study Record Updates

• Last Update Posted (Estimate): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 20, 2016
• Last Verified: March 1, 2016

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: Tibonina/ IUGR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes