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

Postpartum Hemorrhage Clinical Trial

Official title:

COMPARISON BETWEEN RECTAL & SUBLINGUAL MISOPROSTOL BEFORE CAESARIAN SECTION TO REDUCE INTRA & POST-OPERATIVE BLOOD LOSS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083107
• Other study ID #: 9021344
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 7, 2014
• Last updated: November 22, 2015
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2015
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postoperative Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
Comparison of different routes of administration of 400 micro gram misoprostol

Other:
• Placebo

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Hemoglobin Concentration		24 hours postoperative from baseline hemoglobin	No
Other	Change in Hematocrite Value		24 hours postoperative from baseline hematocrite value	No
Primary	Intraoperative Blood Loss		from start of cesarean section till the end of operation (average one hour)	Yes
Secondary	Need for Extra Ecbolics (Oxytocin).		from start of cesarean section till the end of operation (average one hour)	Yes
Secondary	APGAR Score	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).	1minute and 5 minutes from delivery of the fetus	No
Secondary	Time to Resume Bowel Habits		average 24 hours	No
Secondary	Need for Extra Analgesics		average 24 hours	Yes
Secondary	Need for Postoperative Blood Transfusion		average 24 hours	Yes
Secondary	Incidence of Wound Sepsis		upto one week	No
Secondary	Incidence of Adverse Effects		24 hours	No