Placenta Previa Clinical Trial
Official title:
Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.
NCT number | NCT03542552 |
Other study ID # | ONIMS |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | April 30, 2021 |
Verified date | July 2021 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 28+0 weeks of pregnancy and till delivery of the fetus. it occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide
Status | Completed |
Enrollment | 176 |
Est. completion date | April 30, 2021 |
Est. primary completion date | March 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Estimated gestational age : between 28 weeks and 37 week's gestation - Confirmed Placenta previa; either major or minor degrees. - Placenta previa with preterm uterine contractions Exclusion Criteria: - Severe attack of bleeding requiring an immediate intervention. - Fetal heart rates instability or non-reassuring tracing - Intrauterine fetal death or major fetal anomalies. - If associated with abruptio placentae - Patients with known bleeding disorders or on anticoagulant therapy - Patients with severe medical disorders as myasthenia gravis documented magnesium toxicity. |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut university | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The duration of prolongation of gestation | measured from the time of enrollment to the time of delivery | 1 month |
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