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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-04-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Placenta Previa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nifidipne

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

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

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

Magnisum sulphate

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

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

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

Interventions

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Magnesium Sulfate

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

Intervention Type DRUG

Nifedipine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No