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

Ain Shams University210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

210

Conditions

Transient Tachypnea of the Newborn Neonatal Respiratory Distress

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: up to 24 hours after birth

Secondary Outcomes

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.