Clinical trial NCT02083107: Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
Official title: COMPARISON BETWEEN RECTAL & SUBLINGUAL MISOPROSTOL BEFORE CAESARIAN SECTION TO REDUCE INTRA & POST-OPERATIVE BLOOD LOSS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postpartum Hemorrhage
Keywords: Postpartum hemorrhage
Intrapartum blood loss
Misoprostol
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 636
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative Blood Loss
timeFrame: from start of cesarean section till the end of operation (average one hour)
Secondary outcomes:
measure: Need for Extra Ecbolics (Oxytocin).
timeFrame: from start of cesarean section till the end of operation (average one hour)
measure: APGAR Score
timeFrame: 1minute and 5 minutes from delivery of the fetus
measure: Time to Resume Bowel Habits
timeFrame: average 24 hours
measure: Need for Extra Analgesics
timeFrame: average 24 hours
measure: Need for Postoperative Blood Transfusion
timeFrame: average 24 hours
measure: Incidence of Wound Sepsis
timeFrame: upto one week
measure: Incidence of Adverse Effects
timeFrame: 24 hours
Other outcomes:
measure: Change in Hemoglobin Concentration
timeFrame: 24 hours postoperative from baseline hemoglobin
measure: Change in Hematocrite Value
timeFrame: 24 hours postoperative from baseline hematocrite value
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Mohamed S. Sweed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AinShams University
name: Mourad M. El-Said, Professor
role: STUDY_DIRECTOR
affiliation: AinShams university
name: Amgad E. Abou-Gamrah, Ass.Prof.
role: STUDY_DIRECTOR
affiliation: AinShams University
name: Haitham El-Sabe, MD
role: STUDY_DIRECTOR
affiliation: AinShams University
name: Mohamed M. AbdEl-Hamid, Registrar
role: PRINCIPAL_INVESTIGATOR
References: