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OpenTrials
Completed

NCT Number: NCT03473210

The Value of Amniopatch in Preterm Premature Rupture of Membranes

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hany Hassan

Minya, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotics

Drug

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

Other names: ampicillin erythromycin

Corticosteroid

Drug

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

Other names: Dexamethasone

Amniopatch

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 22, 2018
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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