Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postpartum Hemorrhage

Treatments: Drug: Misoprostol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02083107

9021344

Details and patient eligibility

About

The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.

Enrollment: 636 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients booked for elective cesarean section.
2. Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section

Exclusion criteria

1. Primigravida.
2. Blood dyscrasias.
3. Large fibroids.
4. Multiple pregnancies.
5. Overdistended uterus eg. Hydramnios.
6. Pre-eclampsia.
7. Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
8. Previous history of PPH.
9. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
10. Placenta previa.
11. Contraindication to spinal anesthesia.
12. Previous myomectomy.
13. Previous two or more C.S.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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636 participants in 3 patient groups, including a placebo group

sublingual misoprostol & rectal placebo

Experimental group

Description:

will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".

Treatment:

Drug: Misoprostol

rectal & sublingual placebo

Placebo Comparator group

Description:

will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".

Treatment:

Other: Placebo

rectal misoprostol & sublingual placebo

Experimental group

Description:

will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".

Treatment:

Drug: Misoprostol