The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

Phase 4

Completed

• Conditions: Post Partum Hemorrhage
• Interventions: Procedure: cesarean section; Drug: Oxytocin; Drug: Misoprostol

• Registration Number: NCT03680339
• Lead Sponsor: Cairo University

Brief Summary

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

* Intaoperative blood loss

* Risk of Postpartum hemorraghe in the first 24 hrs

* HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

Detailed Description

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

* Intaoperative blood loss

* Risk of Postpartum hemorraghe in the first 24 hrs

* HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

Study Timeline

• Study Start: 2018-09-02
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

women attending for elective CS.

• Age between 20-35 years.
• Normal placental site
• Normal coagulation profile
• Full term pregnancies(above 37 wks)
• Medically free
• Spinal anesthesia
• Living baby
• Average liquor by U/S

Exclusion Criteria

• • Women attending for emergency CS

  • .age below 20 or above 35
  • Abnormal placentation (Placenta previa,accrete,increta or percreta)
  • Women with coagulopathy
  • Preterm pregnancies (before 37 wks)
  • Medical disorder (Hypertension,Diabetes, Endocrinal disorder)
  • General anathesia
  • IUFD
  • Oligo or polyhydraminos by U/S

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine ecbolic group	cesarean section	100 patients will receive routine ecbolics ( oxytocin) after delivery of baby
Routine ecbolic group	Oxytocin	100 patients will receive routine ecbolics ( oxytocin) after delivery of baby
Misoprostol group	cesarean section	The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Misoprostol group	Oxytocin	The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Misoprostol group	Misoprostol	The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Primary Outcome Measures

Name	Time	Method
postpartum hemorrhage	24 hours after cesarean section

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt