Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

Ain Shams University

Status: Unknown

Conditions: Transient Tachypnea Newborn; Cesarean Delivery Affecting Fetus

Treatments: Drug: Misoprostol; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03031353

AinShamsU103

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 2 patient groups

Misoprostol

Experimental group

Description:

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

Treatment:

Drug: Misoprostol

Placebo

Active Comparator group

Description:

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

Treatment:

Drug: Placebos