Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Neonatal Outcome

Treatments: Drug: Misoprostol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03148717

AS1380

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 December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol.

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: 300 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patients candidate for cesarean section.
2. Full term pregnancies (GA 37- 42 Wks).
3. Age (18-40 yrs).
4. body mass index (BMI) (20-30(Kg/m2 .

Exclusion Criteia:

1. Contraindication to spinal anesthesia.
2. Blood dyscrasias.
3. Large fibroids.
4. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
5. Emergency CS such as fetal distress
6. 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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300 participants in 2 patient groups

Preoperative

Active Comparator group

Description:

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

Treatment:

Other: Placebo

Drug: Misoprostol

Postoperative

Active Comparator group

Description:

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

Treatment:

Other: Placebo

Drug: Misoprostol