NCT03680339

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

September 19, 2018

Last Update Submit

June 24, 2023

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • postpartum hemorrhage

    24 hours after cesarean section

Study Arms (2)

Routine ecbolic group

ACTIVE COMPARATOR

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

Procedure: cesarean sectionDrug: Oxytocin

Misoprostol group

ACTIVE COMPARATOR

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

Procedure: cesarean sectionDrug: MisoprostolDrug: Oxytocin

Interventions

cesarean sectionPROCEDURE

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

Misoprostol groupRoutine ecbolic group
MisoprostolDRUG

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

Also known as: Cytotec
Misoprostol group
OxytocinDRUG

10 IU of oxytocin with fetal delivery

Misoprostol groupRoutine ecbolic group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 31304593DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Cesarean SectionMisoprostolOxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, OperativeProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Ahmed maged, MD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 21, 2018

Study Start

September 2, 2018

Primary Completion

January 1, 2019

Study Completion

January 28, 2019

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations

EG(1)