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The Value of Amniopatch in Preterm Premature Rupture of Membranes

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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

Tracking Information
First Submitted Date  ICMJE March 15, 2018
First Posted Date  ICMJE March 22, 2018
Last Update Posted Date March 22, 2018
Actual Study Start Date  ICMJE October 1, 2016
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Value of Amniopatch in Preterm Premature Rupture of Membranes
Official Title  ICMJE The Value of Amniopatch in Pregnancies Associated With Spontaneous Preterm Premature Rupture of Fetal Membranes:A Randomized Controlled Trial
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Preterm Premature Rupture of Membrane
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Antibiotics
    • Drug: Corticosteroid
    • Procedure: Amniopatch
  • Active Comparator: control group
    in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids
    Interventions:
    • Drug: Antibiotics
    • Drug: Corticosteroid
Publications * Maged AM, Kamel HH, Sanad AS, Mahram AE, AbdAllah AA, Elkhateeb R, Bhaa HA, Hussein EA, Essam A, Ibrahim S. The value of amniopatch in pregnancies associated with spontaneous preterm premature rupture of fetal membranes: a randomized controlled trial. J Matern Fetal Neonatal Med. 2019 May 7:1-7. doi: 10.1080/14767058.2019.1605348. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2018)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 11, 2018
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03473210
Other Study ID Numbers  ICMJE 34
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ahmed Maged, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ahmed Maged professor
PRS Account Cairo University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP