The Value of Amniopatch in Preterm Premature Rupture of Membranes
Primary Purpose
Preterm Premature Rupture of Membrane
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Antibiotics
Corticosteroid
Amniopatch
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Premature Rupture of Membrane
Eligibility Criteria
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
Sites / Locations
- Hany Hassan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Amniopatch group
control group
Arm Description
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.
in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids
Outcomes
Primary Outcome Measures
Amniotic fluid index
increase in amniotic fluid index to reach above the 10th percentile for the gestational age
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03473210
Brief Title
The Value of Amniopatch in Preterm Premature Rupture of Membranes
Official Title
The Value of Amniopatch in Pregnancies Associated With Spontaneous Preterm Premature Rupture of Fetal Membranes:A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
March 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of Membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amniopatch group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Other Intervention Name(s)
ampicillin erythromycin
Intervention Description
ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
Intervention Type
Procedure
Intervention Name(s)
Amniopatch
Intervention Description
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
Primary Outcome Measure Information:
Title
Amniotic fluid index
Description
increase in amniotic fluid index to reach above the 10th percentile for the gestational age
Time Frame
one week after the procedure
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged
Organizational Affiliation
professor
Official's Role
Study Director
Facility Information:
Facility Name
Hany Hassan
City
Minya
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Value of Amniopatch in Preterm Premature Rupture of Membranes
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