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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Post Partum Hemorrhage

Treatments: Drug: Oxytocin; Drug: Misoprostol; Procedure: cesarean section

Study type: Interventional

Funder types: Other

Identifiers

NCT03680339

42

Details and patient eligibility

About

• 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

Full 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

Enrollment: 200 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Routine ecbolic group

Active Comparator group

Description:

100 patients will receive routine ecbolics ( oxytocin) after delivery of baby

Treatment:

Procedure: cesarean section

Drug: Oxytocin

Misoprostol group

Active Comparator group

Description:

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

Treatment:

Procedure: cesarean section

Drug: Misoprostol

Drug: Oxytocin