Prevention of premature birth by Nifedipine alone or with Indomethacin

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2020
INTERVENTION: Indomethacin and Nifedipine combination therapy nifedipine monotherapy CONDITION: ; Pregnancy and Childbirth Pregnancy and Childbirth PRIMARY OUTCOME: The primary outcome will be an estimation of the tocolytic efficacy and safety profile of the tocolytic therapies Indomethacin/Nifedipine combination versus Nifedipine monotherapy on delivering mother, which will be assessed in terms of the proportion of women who will not deliver and who will not need an alternate tocolytic medication within 48 hours after the first administration of the study drug. Safety assessment will be by assessing maternal associated adverse effects that included maternal tachycardia (i.e. heart rate above 120 beats per minute), hypotension (i.e. systolic blood pressure less than 90 mm Hg), other symptoms like palpitations, headache, nausea, vomiting, itching, and rash. SECONDARY OUTCOME: To estimate associated neonatal morbidity and mortality may associate with the tocolytic therapies Indomethacin/Nifedipine combination versus Nifedipine monotherapy which includes gestational age at delivery and neonatal morbidity and mortality related to prematurity (lung diseases, severe intraventricular hemorrhage, periventricular leukomalacia, sepsis, necrotizing enterocolitis), gestational age at delivery. That will be assessed until discharge from the hospital or neonatal death. INCLUSION CRITERIA: Women, aged =18 years, who diagnosed as threatened preterm labor patient And their gestational age is between 25 and 34 weeks are eligible for this trial participation. The diagnosis of threatened preterm labor is defined by uterine contractions, at least 3 contractions per 30 minutes, and one of the following: 1‐ a cervical length of =10 mm or 2) a cervical length of 11‐30 mm 3‐ ruptured amniotic membranes. Patients with singleton or twin pregnancies are eligible, Any fetus position will be included.
Epistemonikos ID: 45f6f179da235262c530edd1b9b95490a57b8ede
First added on: Aug 24, 2024