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

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03542552
• Collaborator: (none)
• Enrollment: 176
• Location: 1
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site Per Month: 5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Placenta Previa	Drug: Magnesium Sulfate; Drug: Nifedipine	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Mar 30, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The duration of prolongation of gestation [1 month]

   measured from the time of enrollment to the time of delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ramy nasser, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03542552
• Other Study ID Numbers: ONIMS
• First Posted: May 31, 2018
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obstetric Labor, Premature; Placenta Previa; Magnesium Sulfate; Nifedipine

Study Results

No Results Posted as of Jul 28, 2021