The Value of Amniopatch in Preterm Premature Rupture of Membranes

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Preterm Premature Rupture of Membrane

Intervention / Treatment
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* Drug: Antibiotics
* Drug: Corticosteroid
* Procedure: Amniopatch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amniopatch group<br>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. | Drug: Antibiotics<br>* ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days<br>* Other names: ampicillin erythromycin;Drug: Corticosteroid<br>* dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses<br>* Other names: Dexamethasone;Procedure: Amniopatch<br>* 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<br>|
| Active Comparator: control group<br>in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids | Drug: Antibiotics<br>* ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days<br>* Other names: ampicillin erythromycin;Drug: Corticosteroid<br>* dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses<br>* Other names: Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amniotic fluid index | increase in amniotic fluid index to reach above the 10th percentile for the gestational age | one week after the procedure |