Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

Not Applicable

• Conditions: Transient Tachypnea Newborn; Cesarean Delivery Affecting Fetus
• Interventions: Drug: Placebos; Drug: Misoprostol

• Registration Number: NCT03031353
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-27
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-25
• Status Verified: 2018-05
• Primary Completion: 2018-05
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-05-29
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	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
Misoprostol	Misoprostol	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

Primary Outcome Measures

Name	Time	Method
The need for admission to neonatal intensive care unit (NICU)	first 24 hours after delivery	Number of newborns admitted to NICU for respiratory morbidity

Secondary Outcome Measures

Name	Time	Method
APGAR score below 6 at 5 minute	5 minutes after delivery	number of newborns delivered with APGAR score below 6 at 5 minutes

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Al Qahirah, Egypt