Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03473210
Enrollment
100
Registered
2018-03-22
Start date
2016-10-01
Completion date
2018-03-11
Last updated
2018-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Premature Rupture of Membrane

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

Interventions

DRUGAntibiotics

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

DRUGCorticosteroid

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

PROCEDUREAmniopatch

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Amniotic fluid indexone week after the procedureincrease in amniotic fluid index to reach above the 10th percentile for the gestational age

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026