NCT03473210

The Value of Amniopatch in Preterm Premature Rupture of Membranes

The Value of Amniopatch in Pregnancies Associated With Spontaneous Preterm Premature Rupture of Fetal Membranes:A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34 weeks of gestational age. Participants were randomized equally into 2 groups. Group I in which amniopatch was done (an amnioinfusion of platelet concentrate followed by fresh frozen plasma in addition to the routine management used in the control group. Group II were treated with routine management including antibiotics and corticosteroids

Detailed description

All patients were started on a regimen of hospital bed rest and received antibiotic prophylaxis consisting of ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days . Antenatal corticosteroids were given in the form of dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses. Fifty to two hundred ml of normal saline was infused to create an adequate pocket in which the infusion needle can be stabilized. After injection of normal saline, alternate infusions of 20 mL of platelets, normal saline (which does not contain Calcium, needed for the clotting process), and 20 mL of (FFP). The infused substances were warmed to a temperature of 37°c. Avoiding contact between the blood products prevents clotting in the lines. During infusion, the fetal heart rate as well as the accumulation of amniotic fluid was monitored by ultrasound. Usually a total of around 60-80 mL of platelets, 100-150 mL of FFP and 100-150 mL of amnioinfusion fluid was used throughout the procedure

Conditions

• Preterm Premature Rupture of Membrane

Interventions

Type	Name	Description
DRUG	Antibiotics	ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
DRUG	Corticosteroid	dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
PROCEDURE	Amniopatch	a total of around 60-80 mL of platelets, 100-150 mL of FFP and 100-150 mL of amnioinfusion fluid was used throughout the procedure

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-12-30
• Completion: 2018-03-11
• First posted: 2018-03-22
• Last updated: 2018-03-22

Locations

1 site across 1 country: Egypt