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

Phase 2

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Other: Placebo; Drug: Misoprostol

• Registration Number: NCT02083107
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-11
• Results First Submitted: 2014-04-24
• Results First Submitted QC: 2014-05-26
• Results First Posted: 2014-06-27
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-22
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 636

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rectal & sublingual placebo	Placebo	will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
rectal misoprostol & sublingual placebo	Misoprostol	will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".
sublingual misoprostol & rectal placebo	Misoprostol	will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".

Primary Outcome Measures

Name	Time	Method
Intraoperative Blood Loss	from start of cesarean section till the end of operation (average one hour)

Secondary Outcome Measures

Name	Time	Method
Need for Extra Analgesics	average 24 hours
Incidence of Adverse Effects	24 hours
Need for Extra Ecbolics (Oxytocin).	from start of cesarean section till the end of operation (average one hour)
APGAR Score	1minute and 5 minutes from delivery of the fetus	The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0).
Time to Resume Bowel Habits	average 24 hours
Need for Postoperative Blood Transfusion	average 24 hours
Incidence of Wound Sepsis	upto one week

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt