Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs

NCT05345132 | Unknown DMC

• 1 other identifier: ASsiut TOcolytic Study 1
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This trial is designed to compare between the effectiveness of nifedipine plus magnesium sulfate (MgSO4) and MgSO4 alone for tocolysis in women with threatened preterm labor. Patient Population: The population will include pregnant women at gestational age between 28 and 31 weeks who are 18 years old or older and have signs of threatened preterm labor. Study Design: This is a single-center, prospective, randomized controlled clinical trial. A total of 264 women pregnant between 28 and 31 weeks having threatened preterm labor will be enrolled and randomized into two parallel treatment arms. Patients in the group A will receive nifedipine plus MgSO4, while patients in group B will MgSO4 only. Treatment: All patients will be randomized on the day of enrollment. Patients with threatened preterm labor will receive the respective tocolysis in each group. All patients will receive corticosteroids for lung maturity according to the local protocol. Primary outcome: Number of women not delivered within 48 hours of starting tocolytic therapy. Secondary outcomes: perinatal mortality, a composite of adverse neonatal outcomes, birth weight, days on ventilation support, length of admission in neonatal intensive care, prolongation of pregnancy more than 7 days, delivery after 37 weeks of gestation, number of days till delivery, maternal mortality, maternal infection, and harm to mother from intervention.

Conditions

Threatened Preterm Labor

Outcome Measures

Primary Outcomes (1)

• Number of women not delivered within 48 hours of starting tocolytic therapy.

  postponing delivery for at least 48 hours to allow the time for corticosteroid administration for fatal lung maturity

  48 hours

Secondary Outcomes (10)

• Perinatal mortality

  From starting treatment until 1 month of delivery

• A composite of adverse neonatal outcomes

  within 1 month of delivery

• days on ventilation support

  within 1 month of delivery

• length of admission in neonatal intensive care

  within 1 month of delivery

• Prolongation of pregnancy more than 7 days

  7 days after initiation of therapy

Study Arms (2)

A

ACTIVE COMPARATOR

Nifedipine + Magnesium sulfate

Drug: Nifedipine 20 Mg; Drug: Magnesium sulfate

B

ACTIVE COMPARATOR

Magnesium Sulfate

Drug: Magnesium sulfate

Interventions

Nifedipine 20 Mg DRUG

The initial dose of nifedipine will be 2 × 10 mg nifedipine capsules orally in the first hour, followed by 20 mg slow-release nifedipine every 6 hours for the next 47 hours. In the first hour after starting nifedipine, blood pressure and heart rate will be measured every 15 minutes. If blood pressure remains within the normal limits, treatment will be continued.

A

Magnesium sulfate DRUG

Women will also receive MgSo4 as a loading dose of MgSo4 will be given immediately after enrollment as 4 gm diluted in 200 mL of saline solution administered intravenous over a period of 20 minutes. Afterwards, the maintenance dose of MgSo4 will be administered intravenous in a dose of 1 gm/hour given as 6 gm diluted in 500 mL saline solution titrated with a rate of 100 mL per hour, then this dose is repeated every 6 hours for 48 hours. Respiratory rate and knee jerk will be assessed hourly for women in the MgSo4 group. Serum magnesium level will be measured if clinically indicated.

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women with threatened preterm labor defined as 3 or more uterine contractions in 30 minutes confirmed by cardiotocography.
• Gestational age from 28 week + 0 days to (inclusive) 31 weeks + 6 days.
• Women with singleton or multiple pregnancy.
• Women with preterm prelabor rupture of membranes (PROM) will be included if they have uterine contractions.

You may not qualify if:

• Contraindications for the use of either drugs, such as cardiac disease, hypotension, myasthenia gravis, or renal impairment.
• Contraindications for tocolysis, such as intrauterine demise, intrauterine infection, fetal distress, placental separation, or severe pre-eclampsia.
• Cervical dilatation \> 5 cm.
• Cervical length \> 30 mm by trans-vaginal ultrasound.
• Cervical cerclage.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Interventions

Nifedipine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Karim S Abdallah, MD

CONTACT

+201270595485; karimsayed88@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 25, 2022
• Study Start: April 10, 2022
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)