The Value of Amniopatch in Preterm Premature Rupture of Membranes
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| ClinicalTrials.gov Identifier: NCT03473210 |
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Recruitment Status :
Completed
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Preterm Premature Rupture of Membrane | Drug: Antibiotics Drug: Corticosteroid Procedure: Amniopatch | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Value of Amniopatch in Pregnancies Associated With Spontaneous Preterm Premature Rupture of Fetal Membranes:A Randomized Controlled Trial |
| Actual Study Start Date : | October 1, 2016 |
| Actual Primary Completion Date : | December 30, 2017 |
| Actual Study Completion Date : | March 11, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Amniopatch group
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.
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Drug: Antibiotics
ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
Other Name: ampicillin erythromycin Drug: Corticosteroid dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
Other Name: Dexamethasone 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 |
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Active Comparator: control group
in which women were subjected to conservative management with prophylactic antibiotics and antenatal corticosteroids
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Drug: Antibiotics
ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
Other Name: ampicillin erythromycin Drug: Corticosteroid dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
Other Name: Dexamethasone |
- 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
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473210
| Egypt | |
| Hany Hassan | |
| Minya, Egypt | |
| Study Director: | Ahmed Maged | professor |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ahmed Maged, professor, Cairo University |
| ClinicalTrials.gov Identifier: | NCT03473210 History of Changes |
| Other Study ID Numbers: |
34 |
| First Posted: | March 22, 2018 Key Record Dates |
| Last Update Posted: | March 22, 2018 |
| Last Verified: | March 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Erythromycin Erythromycin Estolate Erythromycin Ethylsuccinate Erythromycin stearate Premature Birth Fetal Membranes, Premature Rupture Rupture Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Wounds and Injuries Anti-Bacterial Agents Ampicillin Antibiotics, Antitubercular Dexamethasone |
Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents Antitubercular Agents |