The Value of Amniopatch in Preterm Premature Rupture of Membranes

NCT ID: NCT03473210

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2018-03-11

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

Conditions

Preterm Premature Rupture of Membrane

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Antibiotics

Intervention Type: DRUG

ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days

Corticosteroid

Intervention Type: DRUG

dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses

Amniopatch

Intervention Type: PROCEDURE

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

control group

in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids

Group Type: ACTIVE_COMPARATOR

Antibiotics

Intervention Type: DRUG

ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days

Corticosteroid

Intervention Type: DRUG

dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses

Interventions

Antibiotics

ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days

Intervention Type: DRUG

Corticosteroid

dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

Other Intervention Names

ampicillin erythromycin; Dexamethasone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maged

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged

Role: STUDY_DIRECTOR

professor

Locations

Hany Hassan

Minya, , Egypt

Countries

Egypt

Other Identifiers

34

Identifier Type: -

Identifier Source: org_study_id