- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Minya, Egypt
- Hany Hassan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Amniopatch group
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.
|
ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
Other Names:
dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
Other Names:
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
|
Active Comparator: control group
in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids
|
ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
Other Names:
dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amniotic fluid index
Time Frame: one week after the procedure
|
increase in amniotic fluid index to reach above the 10th percentile for the gestational age
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one week after the procedure
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: ahmed maged, Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Rupture
- Premature Birth
- Fetal Membranes, Premature Rupture
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protein Synthesis Inhibitors
- Dexamethasone
- Erythromycin
- Ampicillin
- Anti-Bacterial Agents
Other Study ID Numbers
- 34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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