Preterm Premature Rupture of MembraneNCT03473210
The Value of Amniopatch in Preterm Premature Rupture of Membranes
A study testing Antibiotics, Corticosteroid and Amniopatch in people with Preterm Premature Rupture of Membrane, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Premature Rupture of Membrane
- What is being tested?
- Antibiotics, Corticosteroid and Amniopatch
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2016to 11 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Amniopatch in Pregnancies Associated With Spontaneous Preterm Premature Rupture of Fetal Membranes:A Randomized Controlled Trial
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
Read the 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
- Conditions
- Preterm Premature Rupture of Membrane
- Being tested
- Antibiotics, Corticosteroid, Amniopatch
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Also called ampicillin erythromycin
ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
CorticosteroidDrug
Also called Dexamethasone
dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
AmniopatchProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Antibiotics; Drug: Corticosteroid; Procedure: Amniopatch |
| control group | Active comparator | in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids Receives: Drug: Antibiotics; Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amniotic fluid index
increase in amniotic fluid index to reach above the 10th percentile for the gestational age
Measured: one week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Oct 2016
- Primary completion30 Dec 2017
- Study completion11 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembraneStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473210
- Sponsor's protocol ID
- 34
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Amniopatch in Pregnancies Associated With Spontaneous Preterm Premature Rupture of Fetal Membranes:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03473210
- Acronym / sponsor ID
- 34
- Conditions
- Preterm Premature Rupture of Membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 11 Mar 2018 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniopatch group | Active comparator | Drug: Antibiotics, Drug: Corticosteroid, Procedure: Amniopatchin 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. |
| control group | Active comparator | Drug: Antibiotics, Drug: Corticosteroidin which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsAlso: ampicillin erythromycinampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days | Drug | Amniopatch group, control group |
| CorticosteroidAlso: Dexamethasonedexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses | Drug | Amniopatch group, control group |
| Amniopatcha 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 | Procedure or surgery | Amniopatch group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotics, Corticosteroid and Amniopatch in people with Preterm Premature Rupture of Membrane, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amniotic fluid index (time frame: one week after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.