Lactoferrin or Progesterone for Prevention of Preterm Delivery

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Primary endpoint will be evaluate the effectiveness of vaginal lactoferrin in the reduction of the 30% of preterm deliveries versus the use of progesterone, in specific selected patients, with consequent improvement in neonatal outcome.

Secondary endpoint will be compare antibacterial and anti-inflammatory activity of lactoferrin by evaluation of systemic biochemical and urinary markers.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova; University of Padua
• Treatments: Lactoferrin; Progesterone

Criteria

Inclusion Criteria:

• Cervical length less than 25 mm between 24 and 34 weeks' gestation (with or without funnelling)

• cervical effacement less than 50 percent and cervical dilatation less than 3 cm

• uterine contractions less than 4 in 30 minutes

• singleton pregnancy

• absence of chorioamnionitis signs (white cells count< 15.000, Reactive Protein C< 10 mg/l, Procalcitonin levels < 0,05 ng/ml),

• absence of premature membrane rupture (pPROM).

Exclusion Criteria:

• Fetal abnormalities such as severe intrauterine growth restriction and fetal malformations with progressive deterioration

• Maternal diseases such as gestation diabetes insulin-treated, severe nephropaties, severe cardiopathies, autoimmune diseases

• Twin pregnancy

• Signs of maternal infections (chorioamnionitis)

• Premature rupture of membrane