Phase 3
Completed N=636
Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
Source: ClinicalTrials.gov NCT02083107 ↗Enrolled (actual)
636
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Intraoperative Blood Loss — 357.8; 641.7; 457.5 millilitres
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.
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 | — |
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. Informational only — not medical advice.