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

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Other: Placebo; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 636
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sublingual misoprostol & rectal placebo; will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".	Drug: Misoprostol; Comparison of different routes of administration of 400 micro gram misoprostol; Other Names: Cytotec; Misotac
Placebo Comparator: rectal & sublingual placebo; will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".	Other: Placebo
Experimental: rectal misoprostol & sublingual placebo; will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".	Drug: Misoprostol; Comparison of different routes of administration of 400 micro gram misoprostol; Other Names: Cytotec; Misotac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative Blood Loss	from start of cesarean section till the end of operation (average one hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Extra Ecbolics (Oxytocin).		from start of cesarean section till the end of operation (average one hour)
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
Time to Resume Bowel Habits		average 24 hours
Need for Extra Analgesics		average 24 hours
Need for Postoperative Blood Transfusion		average 24 hours
Incidence of Wound Sepsis		upto one week
Incidence of Adverse Effects		24 hours

Other Outcome Measures

Outcome Measure	Time Frame
Change in Hemoglobin Concentration	24 hours postoperative from baseline hemoglobin
Change in Hematocrite Value	24 hours postoperative from baseline hematocrite value

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Mourad M. El-Said, Professor, Ainshams university; Study Director: Amgad E. Abou-Gamrah, Ass.Prof., Ainshams university; Study Director: Haitham El-Sabe, MD, Ainshams university; Principal Investigator: Mohamed M. AbdEl-Hamid, Registrar, Ainshams university

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: March 7, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 11, 2014

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: November 22, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Misoprostol; Postpartum hemorrhage; Intrapartum blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Postoperative Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 9021344