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Trial record 71 of 182 for:    ERYTHROMYCIN

The Value of Amniopatch in Preterm Premature Rupture of Membranes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03473210
Recruitment Status : Completed
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

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

Condition or disease Intervention/treatment Phase
Preterm Premature Rupture of Membrane Drug: Antibiotics Drug: Corticosteroid Procedure: Amniopatch Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Value of Amniopatch in Pregnancies Associated With Spontaneous Preterm Premature Rupture of Fetal Membranes:A Randomized Controlled Trial
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : March 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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.
Drug: Antibiotics
ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
Other Name: ampicillin erythromycin

Drug: Corticosteroid
dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
Other Name: Dexamethasone

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

Active Comparator: control group
in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids
Drug: Antibiotics
ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
Other Name: ampicillin erythromycin

Drug: Corticosteroid
dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
Other Name: Dexamethasone




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473210


Locations
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Egypt
Hany Hassan
Minya, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ahmed Maged professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03473210     History of Changes
Other Study ID Numbers: 34
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Premature Birth
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Anti-Bacterial Agents
Ampicillin
Antibiotics, Antitubercular
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Antitubercular Agents