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

Primary Purpose

Placenta Previa

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Magnesium Sulfate

Nifedipine

About this trial

This is an interventional prevention trial for Placenta Previa

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.

Sites / Locations

Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nifidipne

Magnisum sulphate

Arm Description

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

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

Outcomes

Primary Outcome Measures

The duration of prolongation of gestation

measured from the time of enrollment to the time of delivery

Secondary Outcome Measures

Full Information

NCT ID

NCT03542552

First Posted

May 19, 2018

Last Updated

July 26, 2021

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03542552

Brief Title

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

Official Title

Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

March 30, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Placenta Previa

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

176 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nifidipne

Arm Type

Active Comparator

Arm Description

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

Arm Title

Magnisum sulphate

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Magnesium Sulfate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nifedipine

Intervention Description

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

Primary Outcome Measure Information:

Title

The duration of prolongation of gestation

Description

measured from the time of enrollment to the time of delivery

Time Frame

1 month

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Assiut university

City

Assiut

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

35947046

Citation

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.

Results Reference

derived

Learn more about this trial

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

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