The Value of Amniopatch in Preterm Premature Rupture of Membranes

March 15, 2018 updated by: Ahmed Maged, Cairo University

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

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

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt
        • Hany Hassan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Antibiotics
ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
Other Names:
  • ampicillin erythromycin
Drug: Corticosteroid
dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
Other Names:
  • 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 Names:
  • ampicillin erythromycin
Drug: Corticosteroid
dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
Other Names:
  • Dexamethasone

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
one week after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: ahmed maged, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

March 11, 2018

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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