Phase 3
N=636
Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
Postpartum Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02083107 ↗Enrolled (actual)
636
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Intraoperative Blood Loss — 357.8; 641.7; 457.5 millilitres
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Misoprostol (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ain Shams University
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Blood Loss |
357.8; 641.7; 457.5 | — |
| SECONDARY Need for Extra Ecbolics (Oxytocin). |
209; 206; 204 | — |
| SECONDARY APGAR Score |
6.5; 6.5; 6.5; 8.5; 8.5; 8.5 | — |
| SECONDARY Time to Resume Bowel Habits |
15.1; 14.7; 14.5 | — |
| SECONDARY Need for Extra Analgesics |
56; 62; 50 | — |
| SECONDARY Need for Postoperative Blood Transfusion |
4; 10; 5 | — |
| SECONDARY Incidence of Wound Sepsis |
3; 5; 4 | — |
| SECONDARY Incidence of Adverse Effects |
44; 11; 26; 42; 11; 24 | — |
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
- Patients booked for elective cesarean section.
- Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section
Exclusion Criteria
- Primigravida.
- Blood dyscrasias.
- Large fibroids.
- Multiple pregnancies.
- Overdistended uterus eg. Hydramnios.
- Pre-eclampsia.
- Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
- Previous history of PPH.
- Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- Placenta previa.
- Contraindication to spinal anesthesia.
- Previous myomectomy.
- Previous two or more C.S.
Data sourced from ClinicalTrials.gov (NCT02083107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.