Effects of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on Inflammatory Mediators

Università degli Studi di Ferrara

Status and phase: Completed; Phase 2

Conditions: Pregnancy

Treatments: Drug: Lactoferrin

Study type: Interventional

Funder types: Other

Identifiers

NCT02695563

PRUa1GR-2013-00000220

Details and patient eligibility

About

The aim of the study is to evaluate the effect of vaginal lactoferrin administration on amniotic fluid PGE2 level and MMP-TIMP system in women undergoing genetic amniocentesis. Two groups of patients will be prospectively enrolled: not treated with lactoferrin and treated with vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.

Full description

Pregnant women undergoing genetic amniocentesis within the 16th-18th gestational week will be enrolled at the Obstetric Unit, University of Ferrara.

The selected patients will be randomly assigned to receive a vaginal compound containing 300 mg of lactoferrin 4 hours before amniocentesis or they will be untreated (controls).

Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not required for clinical purposes will be centrifuged to remove particulate material and the supernatants will be aliquoted and stored at -80°C until assay.

Enrollment: 111 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• singleton gestation
• maternal age as indication to fetal karyotyping

Exclusion criteria

• consumption of drugs interfering with the immune system
• previous miscarriages
• pregnancy at risk for maternal or fetal disease
• lactose intolerance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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111 participants in 2 patient groups

controls

No Intervention group

Description:

The patients will be not treated with vaginal lactoferrin

Lactoferrin

Active Comparator group

Description:

The patients will be administered with a single dose of 300 mg vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.

Treatment:

Drug: Lactoferrin