The Value of Amniopatch in Preterm Premature Rupture of Membranes

Not Applicable

Completed

Brief 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

Recruitment & Eligibility

Inclusion Criteria

healthy pregnant women
gestational age of 24 to 34 weeks (calculated by the sure dates of the last menstrual period and confirmed by early 1st trimesteric ultrasound).

All women carried a normal healthy singleton fetus

Exclusion Criteria

established preterm labor at admission
those with symptoms or signs suggestive of clinical chorioamnionitis.
women with uncontrolled medical disorder e.g. severe hypertension, uncontrolled diabetes, chronic renal impairment
women with vaginal bleeding regardless its cause.
Pregnancies associated with major congenital fetal malformations
placental insufficiency or anomalies
anterior position of the placenta
iatrogenic PPROM

Arm && Interventions

Group	Intervention	Description
Amniopatch group	Corticosteroid	in which women were subjected to active treatment included prophylactic antibiotics and antenatal corticosteroids with an effort to seal the ruptured membranes using the amniopatch technique.
control group	Antibiotics	in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids
Amniopatch group	Antibiotics	in which women were subjected to active treatment included prophylactic antibiotics and antenatal corticosteroids with an effort to seal the ruptured membranes using the amniopatch technique.
Amniopatch group	Amniopatch	in which women were subjected to active treatment included prophylactic antibiotics and antenatal corticosteroids with an effort to seal the ruptured membranes using the amniopatch technique.
control group	Corticosteroid	in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids

Primary Outcome Measures

Name	Time	Method
Amniotic fluid index	one week after the procedure	increase in amniotic fluid index to reach above the 10th percentile for the gestational age

Secondary Outcome Measures

Name	Time	Method

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial