Preterm Pre-labor Rupture of Membranes Clinical Trial
Official title:
Different Azithromycin Protocols for Management of Preterm Pre-labor Rupture of Membranes
| NCT number | NCT04202380 |
| Other study ID # | A-PROM |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 1, 2020 |
| Est. completion date | March 1, 2021 |
| Verified date | April 2024 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The preterm prelabour rupture of membranes is defined as the spontaneous rupture of the fetal membranes before 37 completed weeks. Preterm prelabour rupture of membranes complicates up to 3% of pregnancies and is associated with 30-40% of preterm births. preterm prelabour rupture of membranes can result in significant neonatal morbidity and mortality, primarily from prematurity, sepsis, cord prolapse, and pulmonary hypoplasia. In addition, there are risks associated with chorioamnionitis and placental abruption The diagnosis of spontaneous rupture of the membranes is made by maternal history followed by a sterile speculum examination. If on speculum examination, no amniotic fluid is observed, clinicians should consider performing an insulin-like growth factor-binding protein-1 or placental alpha microglobulin-1 test of vaginal fluid to guide further management. One of the risks associated with preterm prelabour rupture of membranes is ascending infection leading to chorioamnionitis, and subsequent fetal and neonatal infection.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | March 1, 2021 |
| Est. primary completion date | January 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility | Inclusion Criteria: 1. Gestational age is between 28 wks and 37wks 2. Singleton living pregnancy. 3. Confirmed Premature Pre-labor rupture of membranes (PPROM). Exclusion Criteria: 1. previable rupture of membranes (<23+6wks) 2. Multiple gestations 3. Macrolide allergy 4. patient receiving combination macrolide therapy 5. lethal fetal anomalies 6. contraindications to expectant management of PPROM at time of diagnosis e.g. concurrent preterm labor, placental abruption, chorioamnionitis or non-reassuring fetal testing |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Women Health Hospital - Assiut university | Assiut |
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Days from diagnosis of preterm pre-labor rupture of membranes to delivery. | 14 days |