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

A

Assiut University

Status and phase

Completed
Phase 3

Conditions

Placenta Previa

Treatments

Drug: Magnesium Sulfate
Drug: Nifedipine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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

Enrollment

176 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

176 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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