Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

Study Overview
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Brief Summary
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Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising. Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.

Official Title
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Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial

Conditions
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Transient Tachypnea Newborn, Cesarean Delivery Affecting Fetus

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years or more. Term singleton pregnancy (38 - 38+6 weeks gestation). Planned for elective transverse lower segment caesarean section with an indication. Exclusion Criteria: Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease. Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol. Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study. Pregnancies with known foetal malformation/s or chromosomal aberration.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br>After preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized | Drug: Misoprostol<br>* Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage<br>* Other names: Mesotac;|
| Active Comparator: Placebo<br>After preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized | Drug: Placebos<br>* placebos tablet will be given before elective Cesarean sections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for admission to neonatal intensive care unit (NICU) | Number of newborns admitted to NICU for respiratory morbidity | first 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APGAR score below 6 at 5 minute | number of newborns delivered with APGAR score below 6 at 5 minutes | 5 minutes after delivery |