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

Post Partum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680339
• Other study ID #: 42
• Status: Completed
• Phase: Phase 4
• Start date: September 2, 2018
• Est. completion date: January 28, 2019

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 28, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Procedure:
• cesarean section
CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers

Drug:
• Misoprostol
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
• Oxytocin
10 IU of oxytocin with fetal delivery

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postpartum hemorrhage		24 hours after cesarean section