The Value of Amniopatch in Preterm Premature Rupture of Membranes

Preterm Premature Rupture of Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03473210
• Other study ID #: 34
• Status: Completed
• Phase: N/A
• First received: March 15, 2018
• Last updated: March 15, 2018
• Start date: October 1, 2016
• Est. completion date: March 11, 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 11, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membrane
• Rupture

Intervention

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

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

Locations

Country	Name	City	State
Egypt	Hany Hassan	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amniotic fluid index	increase in amniotic fluid index to reach above the 10th percentile for the gestational age	one week after the procedure