Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section

Study Overview
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Brief Summary
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Neonatal respiratory morbidities represent a common group of post natal complications including respiratory distress syndrome, transient tachypnea of newborn, and persistent pulmonary hypertension of newborn. It is thought that preoperative vaginal misoprostol administration may decrease the incidence of neonatal respiratory morbidity especially transient tachypnea of newborn. And therefore, it may decrease the incidence of admission to neonatal intensive care units for respiratory causes.

Official Title
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Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section

Conditions
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Transient Tachypnea of the Newborn, Neonatal Respiratory Distress

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years or more. Early term singleton pregnancy. Elective caesarian section at (37 - 38+6) weeks of gestation. Any indication for lower uterine segment caesarian section other than labor (as malpresentations, severe preeclampsia, placenta previa with no previous bleeding attacks, Diabetes Mellitus, macrosomic fetus, non reassuring cardiotocogram (CTG), and fetal growth restriction). Informed written consent signed by the participating pregnant woman. Exclusion Criteria: Women having any contraindication to Prostaglandin E1 as hypersensitivity, respiratory disease (especially bronchial asthma), or glaucoma. Any mental problems that block understanding of the nature and all the possible consequences of the procedure and the study. Pregnancies of known fetal diseases or chromosomal abnormalities. Non-singleton pregnancies. Emergency caesarian section as in ruptured membrane and women in labor pain.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol Group<br> | Drug: Misoprostol<br>* Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.<br>* Other names: prostaglandin E1;|
| Placebo Comparator: Placebo Group<br> | Drug: Placebo<br>* Vaginal placebo pills given 90-120 minutes before an elective caesarian section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of neonatal respiratory morbidity (NRM) | The incidence of neonatal respiratory morbidity, especially transient tachypnea of newborn, in early term neonates born to elective caesarian section. | up to 24 hours after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal intensive care unit (NICU) admission | The incidence of the need for neonatal intensive care unit admission during the first ten days after delivery in early term neonates born to elective caesarian section. | up to 24 hours after birth |