Clinical trial NCT05345132: Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs
Official title: Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate Alone for Tocolysis in Pregnant Women at 28 - 31 Weeks Gestation With Threatened Preterm Labor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Threatened Preterm Labor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of women not delivered within 48 hours of starting tocolytic therapy.
timeFrame: 48 hours
Secondary outcomes:
measure: Perinatal mortality
timeFrame: From starting treatment until 1 month of delivery
measure: A composite of adverse neonatal outcomes
timeFrame: within 1 month of delivery
measure: days on ventilation support
timeFrame: within 1 month of delivery
measure: length of admission in neonatal intensive care
timeFrame: within 1 month of delivery
measure: Prolongation of pregnancy more than 7 days
timeFrame: 7 days after initiation of therapy
measure: Delivery after 37 weeks of gestation.
timeFrame: after 37th week of delivery
measure: Number of days till delivery
timeFrame: from starting the intervention until delivery
measure: Maternal mortality rate
timeFrame: from starting treatment until 1 month after delivery
measure: Maternal infection rate
timeFrame: from starting treatment until 1 month after delivery
measure: Harm to mother from interventions (side effects)
timeFrame: from starting treatment until 1 month after delivery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References: