Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cesarean Section

Treatments: Drug: Misoprostol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03144401

AS1374

Details and patient eligibility

About

This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients booked for elective cesarean section.
• Singleton pregnancies.
• Full term pregnancies (GA 37- 42 Wks).
• Age (18-40 yrs).
• body mass index (BMI) (20-30(Kg/m2 .

Exclusion criteria

• Contraindication to spinal anesthesia.
• Blood dyscrasias.
• Large fibroids.
• Multiple pregnancies.
• Overdistended uterus eg. Hydramnios.
• Pre-eclampsia.
• Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
• Previous history of PPH.
• Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
• Placenta previa.
• Previous myomectomy.
• Extreme of BMI (<20 or >30 Kg/m2 ).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

Preoperative

Active Comparator group

Description:

• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".

Treatment:

Other: Placebo

Drug: Misoprostol

Postoperative

Active Comparator group

Description:

• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .

Treatment:

Other: Placebo

Drug: Misoprostol