Clinical trial NCT03680339: The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
Official title: The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Partum Hemorrhage
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: postpartum hemorrhage
timeFrame: 24 hours after cesarean section
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maged AM, Fawzi T, Shalaby MA, Samy A, Rabee MA, Ali AS, Hussein EA, Hammad B, Deeb WS. A randomized controlled trial of the safety and efficacy of preoperative rectal misoprostol for prevention of intraoperative and postoperative blood loss at elective cesarean delivery. Int J Gynaecol Obstet. 2019 Oct;147(1):102-107. doi: 10.1002/ijgo.12922. Epub 2019 Jul 25.