The Value of Amniopatch in Preterm Premature Rupture of Membranes

NCT03473210 | Completed DMC

• 1 other identifier: 34
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Premature Rupture of Membrane

Outcome Measures

Primary Outcomes (1)

• Amniotic fluid index

  increase in amniotic fluid index to reach above the 10th percentile for the gestational age

  one week after the procedure

Study Arms (2)

Amniopatch group

ACTIVE COMPARATOR

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.

Drug: Antibiotics; Drug: Corticosteroid; Procedure: Amniopatch

control group

ACTIVE COMPARATOR

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

Drug: Antibiotics; Drug: Corticosteroid

Interventions

Antibiotics DRUG

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

Also known as: ampicillin erythromycin

Amniopatch group; control group

Corticosteroid DRUG

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

Also known as: Dexamethasone

Amniopatch group; control group

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

Amniopatch group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hany Hassan

Minya, Egypt

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Anti-Bacterial Agents; Adrenal Cortex Hormones; Dexamethasone

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ahmed Maged

  professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 22, 2018
• Study Start: October 1, 2016
• Primary Completion: December 30, 2017
• Study Completion: March 11, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

EG (1)