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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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03542552
Enrollment
176
Registered
2018-05-31
Start date
2018-06-01
Completion date
2021-04-30
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Previa

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

Interventions

DRUGMagnesium Sulfate

Patients received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion

DRUGNifedipine

received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The duration of prolongation of gestation1 monthmeasured from the time of enrollment to the time of delivery

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026