An interventional study of Misoprostol in Neonatal Respiratory Distress, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
Project summary:
Objective: To test the hypothesis that administration of vaginal Misoprostol before elective cesarean section will improve the neonatal respiratory outcomes in late preterm and early term neonates through induction of catecholamine surge.
Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two hundred and ninety two women will be randomly allocated to receive either 50 micrograms of Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or receive nothing (control group; n = 146) .
Main outcome measure: Apgar score at 1 and 5 minutes.
Methodology: After a written informed consent obtained, women who are fitting the inclusion criteria will be randomly allocated using sealed, coded, opaque and sequentially numbered envelopes containing computer generated random numbers into either the study group or the control group. For the study group the enrolled women will receive 50 microgram misoprostol vaginally within 60 minutes before CS. For the control group mothers enrolled will receive nothing.
Observation and data collection: Cardiotocographic monitoring will be undertaken after maternal misoprostol administration to detect any evidence of uterine hyperstimulation and fetal distress.
Ritodrine IV will be used as a tocolytic agent in case of uterine tachysystole. 100 mg of ritodrine will be added to 500 ml of 0.5% dextrose, the solution will be administered as following:
5 drops / minute in the 1st 10 minutes. 10 drops / minute in the next 10 minutes then 15 drops / minute . The clinician should adjust the infusion rate so that the pulse rate doesn't exceed 120b/min and lung bases are free of crepitations.
The surgical and anesthetic teams will be in a state of complete readiness for the ECS from the time of maternal misoprostol administration after enrollment. Details on maternal fluid-electrolyte status during ECS will be recorded as maternal fluid overload is reported to be associated with respiratory distress in the newborn. (SinghiS,Chookang E;1984) blood loss during and 1 hour after the operation will be estimated.
Maternal data: Patient name, hospital number, age, parity, gestational age, any medical disorder and indication of CS.
Neonatal observations: delivery room care details will be noted, neonatal heart rate, respiratory rate, and signs of respiratory distress- for example, grunting, chest wall retractions, nasal flaring- will be recorded hourly in the postnatal ward for eight hours and once only at 24 hours of age after delivery. Management of a neonate with respiratory distress (defined as respiratory rate at rest.60/min and/or signs of respiratory distress) will be left to the neonatal team. Severity of illness, provisional and final diagnosis, and outcome (death/discharge home/transfer to other hospital) will be recorded if any neonate would be admitted to the neonatal intensive care unit for respiratory distress.
1,180 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 161 are open to participants now.
This study's planned enrollment of 292 is above the median of 60 across 712 interventional studies indexed under Respiratory Distress Syndrome, Newborn.
Browse Respiratory Distress Syndrome, Newborn studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
All pregnant women who are planned for elective (planned\& pre labor) cesarean section at 34 -37 weeks gestation.
Exclusion Criteria:
For the study group the enrolled women will receive 50 microgram misoprostol vaginally 60 minutes before CS
Drug: Misoprostol
For the control group mothers enrolled will receive nothing.
Also known as: Prostaglandin E1,Cytotec
1- Rate of Neonatal Intensive Care Unit admission for neonatal respiratory distress.
The number of neonates who need Neonatal Intensive Care Unit admission in each study group
Time frame: During the first 24 hours of life.
Plan to share: Undecided
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome, Newborn→
Assiut University