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Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone.

L

Lo.Li.Pharma

Status

Completed

Conditions

Pregnancy, High Risk

Treatments

Dietary Supplement: HA

Study type

Interventional

Funder types

Industry

Identifiers

NCT04874285
HMW-HA_ABORTION

Details and patient eligibility

About

The trial aims to investigate the effect of supplementation with hyaluronic acid, alpha-lipoic acid, magnesium, vitamin D and vitamin B6 in progesterone-treated pregnant women with risk factors for abortion.

Enrollment

63 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Women with risk factor for abortion (sub-chorionic hematoma during gestation or ART procedures)

Exclusion criteria

  • Other pregnancy-related conditions
  • Diabetes or hypertension
  • Concomitant pharmacological therapies (anticoagulant or antihypertensive)
  • Use of tocolytic drugs two months prior to enrollment
  • Association with hypoglycemic drugs

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

control group
No Intervention group
Description:
Women with risk factors for abortion, treated with progesterone
study group
Experimental group
Description:
Women with risk factors for abortion, treated with progesterone and a dietary supplement containing hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6
Treatment:
Dietary Supplement: HA

Trial contacts and locations

1

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Central trial contact

Cesare Aragona, MD

Data sourced from clinicaltrials.gov

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