Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa

Phase 3

Completed

• Conditions: Placenta Previa
• Interventions: Drug: Magnesium Sulfate; Drug: Nifedipine

• Registration Number: NCT03542552
• Lead Sponsor: Assiut University

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

Detailed Description

There are many tocolytic agents may have a role in conservative management of placenta previa such as magnesium sulfate, calcium channel blockers and β-sympathormimetics. In 2004 Sharma suggests that ritodrine hydrochloride in patients with symptomatic placenta previa tends to prolong the pregnancy and result in an increase in birth weight of the babies without causing any adverse effect on the mother and fetus

Study Timeline

• Study First Submitted: 2018-05-19
• Study First Submitted QC: 2018-05-19
• Study First Posted: 2018-05-31
• Study Start: 2018-06-01
• Primary Completion: 2021-03-30
• Study Completion: 2021-04-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnisum sulphate	Magnesium Sulfate	Patients in the MgSO4 group received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion
Nifidipne	Nifedipine	received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours

Primary Outcome Measures

Name	Time	Method
The duration of prolongation of gestation	1 month	measured from the time of enrollment to the time of delivery

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt