Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa
Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.
1 other identifier
interventional
176
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2018
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2018
CompletedFirst Posted
Study publicly available on registry
May 31, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedJuly 28, 2021
July 1, 2021
2.8 years
May 19, 2018
July 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The duration of prolongation of gestation
measured from the time of enrollment to the time of delivery
1 month
Study Arms (2)
Nifidipne
ACTIVE COMPARATORreceived oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours
Magnisum sulphate
EXPERIMENTALPatients in the MgSO4 group received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion
Interventions
Patients received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion
received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university
Asyut, Egypt
Related Publications (1)
Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
PMID: 35947046DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 19, 2018
First Posted
May 31, 2018
Study Start
June 1, 2018
Primary Completion
March 30, 2021
Study Completion
April 30, 2021
Last Updated
July 28, 2021
Record last verified: 2021-07