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The Value of Amniopatch in Preterm Premature Rupture of Membranes

NCT03473210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-03-22

No results posted yet for this study

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

Conditions

  • Preterm Premature Rupture of Membrane

Interventions

DRUG

Antibiotics

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

DRUG

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged · professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2017-12-30
Completion
2018-03-11

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473210 on ClinicalTrials.gov