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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05343806
Other study ID # ASsiut TOcolytic Study 2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date February 1, 2026

Study information

Verified date December 2023
Source Assiut University
Contact Karim Abdallah, MD
Phone +201270595485
Email karimsayed88@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: This trial is designed to compare between the effectiveness of nifedipine versus magnesium sulfate (MgSO4) for tocolysis in women with threatened preterm labor. Patient Population: The population will include pregnant women at gestational age between 32 and 36 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 32 and 36 weeks having threatened preterm labor will be enrolled and randomized into two parallel treatment arms. Patients in the group A will receive nifedipine, 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 264
Est. completion date February 1, 2026
Est. primary completion date November 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Pregnant women with threatened preterm labor defined as 3 or more uterine contractions in 30 minutes confirmed by cardiotocography. 2. Gestational age from 32 week + 0 days to (inclusive) 36 weeks + 0 days. 3. Women with singleton or multiple pregnancy. 4. Women with preterm prelabor rupture of membranes (PROM) will be included if they have uterine contractions. Exclusion Criteria: 1. Contraindications for the use of either drugs, such as cardiac disease, hypotension, myasthenia gravis, or renal impairment. 2. Contraindications for tocolysis, such as intrauterine demise, intrauterine infection, fetal distress, placental separation, or severe pre-eclampsia. 3. Cervical dilatation > 5 cm. 4. Cervical length > 30 mm by trans-vaginal ultrasound. 5. Cervical cerclage.

Study Design


Intervention

Drug:
Nifedipine 20 Mg
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.
Magnesium Sulfate
Women will receive only MgSo4. 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.

Locations

Country Name City State
Egypt Faculty of Medicine, Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Perinatal mortality Death of the offspring during treatment, labor or neonatal period From starting treatment until 1 month of delivery
Secondary A composite of adverse neonatal outcomes convulsions, apnoea, asphyxia, proven meningitis, pneumothorax or sepsis within 1 month of delivery
Secondary days on ventilation support number of days on mechanical ventilation within 1 month of delivery
Secondary length of admission in neonatal intensive care Number of days in the NICU within 1 month of delivery
Secondary Prolongation of pregnancy more than 7 days Number of women not delivering after at least 7 days from starting the intervention 7 days after initiation of therapy
Secondary Delivery after 37 weeks of gestation number of women delivered after 37 weeks of gestation after 37th week of gestation
Secondary Number of days till delivery from starting the intervention until delivery
Secondary Maternal mortality rate Number of maternal deaths during pregnancy, labor or puerperium from starting treatment until 1 month after delivery
Secondary Maternal infection rate Number of women having Chorioamnionitis, Puerperal sepsis, endometritis, or sepsis from starting treatment until 1 month after delivery
Secondary Harm to mother from interventions (side effects) admission to intensive care, anaphylactic shock, dyspnoea, hypotension (leading to cardiotocography abnormalities), liver test abnormalities (elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT)), general side effects (nausea, vomiting, headache) and postpartum haemorrhage defined as >500 mL blood loss from starting treatment until 1 month after delivery
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Recruiting NCT05345132 - Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs N/A